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Ketamine and psychosis risk: New data

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Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

 

 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

A version of this article first appeared on Medscape.com.

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Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

 

 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

A version of this article first appeared on Medscape.com.

 

Ketamine used to treat severe depression in patients with a history of psychosis does not exacerbate psychosis risk, new research suggests.

A meta-analysis of nine studies, encompassing 41 patients with TRD and a history of psychosis, suggests ketamine is safe and effective and did not exacerbate psychotic symptoms in this patient population.

“We believe our findings could encourage clinicians and researchers to examine a broadened indication for ketamine treatment in individual patients with high levels of treatment resistance, carefully monitoring both clinical response and side effects, specifically looking at possible increases in psychotic symptoms,” study investigator Jolien K. E. Veraart, MD, University of Groningen, University Medical Center Groningen, the Netherlands, told this news organization.

The study was published online July 13 in the Journal of Clinical Psychiatry.
 

Rapid, robust effects

Ketamine has shown “rapid and robust antidepressant effects” in clinical studies. However, this research has not included patients with past or current psychosis, based on the assumption that psychosis will increase with ketamine administration, since side effects of ketamine can include transient “schizophrenia-like” psychotomimetic phenomena, including perceptual disorders and hallucinations in healthy individuals, the investigators note.

Dr. Veraart said psychotic symptoms are “common in people with severe depression,” and these patients have poorer outcomes with pharmacotherapy, psychotherapy, and electroconvulsive therapy.

Additionally, up to 60% of patients with schizophrenia experience negative symptomatology, including loss of motivation, affective blunting, and anhedonia, which “has a clear phenomenological overlap with depression,” the authors write. They also note anti-anhedonic effects of subanesthetic ketamine doses have been reported, without adversely impacting long-term psychotic symptoms in patients with schizophrenia.

“Positive results from carefully monitored trials with ketamine treatment in these patients have motivated us to summarize the currently available knowledge to inform our colleagues,” she said.

To investigate, the researchers conducted a literature search and selected 9 articles (N = 41 patients) that reported on ketamine treatment in patients with a history of psychosis or current psychotic symptoms.

All studies were either case reports or pilot studies, the authors report. Types of patients included those with bipolar or unipolar depression, or depression in schizoaffective disorder , or patients with schizophrenia and concurrent depression. Depressive symptomatology was the treatment target in eight studies, and one study targeted negative symptoms in patients with schizophrenia.

Dosing, frequency, and types of administration (ketamine IV, esketamine IV, or esketamine subcutaneous) varied from study to study.

In seven studies, ketamine was found to improve depressive symptoms, and in two studies, improvement in psychotic symptoms was also shown. Two studies revealed improvement in symptoms of suicidality. Results of the study that measured negative symptoms showed “significant improvement” in five of six patients, with a -37.3% decrease in mean Brief Negative Symptoms Scale (BNSS) from the baseline to the end of four infusions.

“Ketamine showed good antidepressant effects, and, in some cases, the comorbid symptoms even improved or disappeared after ketamine treatment,” Dr. Veraart summarized. However, the effect size of ketamine might be lower in those with a history of psychosis, she added.

She also noted that ketamine administration did not negatively influence the course of psychotic illness or induce psychotic exacerbations in patients.

She pointed to one study limitation, which is that only small, uncontrolled trials were included and that there is a risk for publication bias.
 

 

 

Larger trials needed

Commenting on the study, Dan Iosifescu, MD, MSc, associate professor of psychiatry, New York University School of Medicine, said that if the finding “were based on a larger study it would be very important, as a theoretical risk of psychosis is preventing such patients from access to an otherwise beneficial treatment.”

However, “since the review is based on a small sample, a low risk of psychosis exacerbation after IV ketamine is still possible,” said Dr. Iosifescu, who is also the director of clinical research at the Kline Institute for Psychiatric Research in Orangeburg, New York, and was not involved with the study.

Dr. Veraart agreed, adding that the “efficacy, safety, and tolerability of ketamine in depressed patients with a vulnerability to psychosis should be investigated in well-designed randomized controlled trials before application on a large scale is promoted.”

The study had no specific funding. Dr. Veraart has received speaker honoraria from Janssen outside of the submitted work. The other authors’ disclosures are listed in the original article. Dr. Iosifescu has been a consultant to the Centers of Psychiatric Excellence, advising clinics on the best methods of providing treatment with IV ketamine.

A version of this article first appeared on Medscape.com.

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Strong support for causal role of cannabis in schizophrenia

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The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Psychiatric genomics has a diversity problem

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In combing the genome, scientists can use genetic clues to determine a person’s risk for psychiatric disease and even identify new drug targets. But the benefits of these discoveries will be limited to people of European descent.

Nearly 90% of participants in genome-wide association studies (GWASs), which search for gene variants linked to disease, are of European ancestry. This Eurocentric focus threatens to widen existing disparities in racial and ethnic mental health.

Dr. Solomon Teferra


“If you develop certain interventions based on only a single population profile, then you’ll be leaving out the rest of the populations in the world,” says Solomon Teferra, MD, PhD, associate professor of psychiatry at Addis Ababa University, Ethiopia. In a growing trend, psychiatric researchers are diverging from the field’s European bias and are working to correct the imbalance in DNA databases.

The significant downsides of genomics’ one-track mind

One obstacle hindering therapeutic advances in psychiatry is a shallow understanding of the mechanisms of disorders. “The biggest problem in terms of advancing research for mental health conditions is that we don’t understand the underlying biology,” says Laramie Duncan, PhD, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “Genetics is one of the best ways to systematically look for new clues about the underlying biology.”

At the advent of genomic research, scientists thought it best to study DNA from people of a single ancestry from one continent. “Researchers for a long time held the idea that it was going to be too complicated to include multiple ancestries in the first rounds of genetic analyses,” says Dr. Duncan.

Studying DNA from someone with ancestors from multiple parts of the world wasn’t compatible with methods used in the early days of GWASs. “Individual parts of a person’s DNA can be linked back to one region of the world or another, and most of our methods essentially assume that all of a person’s DNA came from one region of the world,” says Dr. Duncan.

Because many genes are usually involved in psychiatric disorders, scientists need large numbers of participants to detect uncommon, influential variants. Early research was concentrated in North America and Europe so that scientists could readily collect samples from people of European ancestry.

“It then went out of hand because it became routine practice to use only this one group, essentially White, European ancestry people,” says Karoline Kuchenbaecker, PhD, associate professor of psychiatry at University College London.

Yet findings from one population won’t necessarily translate to others. “And that’s exactly what has been shown,” says Dr. Teferra. Polygenic risk scores developed for schizophrenia from European samples, for example, perform poorly among people of African ancestry, although among Europeans, they are strongly effective at differentiating European individuals with and those without schizophrenia. Moreover, drugs that target a gene identified from studies in European populations may be harmful to other groups.

Studies drawn from a diverse pool of participants would benefit a wider swath of humanity. They would also allow scientists to discover small areas of overlap in genomes of different populations, which would help them close in on the true biology of diseases and ensure that “we’re all benefiting from more diverse data in genetics and psychiatric genetics,” says Dr. Kuchenbaecker.
 

 

 

New efforts aim at filling the gaps

Genomic studies are featuring more people of non-European ancestry, but most of that improvement comes from populations of Asian ancestry, not African, Latin American, or Indigenous ancestry.

Efforts to increase representation of persons of African ancestry have largely focused on African Americans; fewer efforts have extended to the African continent, home to the most genetically diverse populations. Even fewer have focused on mental health. “The little that was being done was on a very small scale,” says Karestan Koenen, PhD, a professor at Harvard School of Public Health, Boston.

With this in mind, researchers from institutions in Kenya, Uganda, South Africa, and Ethiopia partnered with researchers at the Broad Institute of the Massachusetts Institute of Technology and Harvard to conduct the largest GWAS of psychiatric disorders in Africa. Dr. Koenen leads the project, Neuropsychiatric Genetics of African Populations–Psychosis (NeuroGAP-Psychosis), which will analyze DNA from over 35,000 people of African ancestry in each of these four countries. Investigators will compare the half of participants who have no history of psychosis with the half with schizophrenia or bipolar disorder in the hopes of identifying the genetic determinants of psychosis.

“Then any potential intervention or therapeutics that will be developed will also be useful for Africans,” says Dr. Teferra, a NeuroGAP principal investigator. Because of the tremendous degree of genetic diversity among people on the continent, however, findings still might not translate to all African populations.

But correcting equity problems in genomics isn’t as simple as recruiting people with non-European backgrounds, especially if those people are unfamiliar with research or have been subject to scientific exploitation. “Special care needs to be taken to, first of all, provide information that’s appropriate [to participants], but also motivate people to take part and then find ways to keep these communities involved and understand what they’re interested in,” says Dr. Kuchenbaecker, who is not involved with NeuroGAP.

For NeuroGAP, the team needed to work with ethical committees at all of the institutions involved, ensure research materials were appropriate for each community’s cultural context, and gain the trust of local communities.

“One of the biggest criticisms within the scientific world is that people from more endowed countries just fly in, bully everyone, collect the data, and leave, with no credit to the local scientists or communities,” says NeuroGAP principal investigator Lukoye Atwoli, MMed, PhD, professor of psychiatry and dean of the Medical College, East Africa, at the Aga Khan University, Nairobi, Kenya. “That is one of the biggest pitfalls we had to grapple with.”

To address that concern, NeuroGAP is training local researchers and is providing them with requested resources so they can carry out similar studies in the future. “We will be looking to address a real need in the academic community and in clinical service delivery,” says Dr. Atwoli.

Dr. Kuchenbaecker says that NeuroGAP demonstrates features necessary for projects seeking to improve equity in psychiatric genomics. “What they’re doing right is recruiting really large numbers, recruiting from different African countries, and involving African investigators,” she says.

In the Americas, Janitza Montalvo-Ortiz, PhD, assistant professor in the Division of Genetics, department of psychiatry, Yale University, New Haven, Conn., and her colleagues are expanding psychiatric genomics projects in Latin America. She co-founded the Latin American Genomics Consortium in 2019, a network of scientists supporting psychiatric genomic research in the region. The consortium also involves the Neuropsychiatric Genetics in Mexican Populations project, which is similar to NeuroGAP and is also led by Dr. Koenan.

The study of Latin American populations is complicated, because genes in these populations reflect Indigenous American, European, and African ancestries. Even when investigators sampled DNA from Latin American individuals, that data often went unused. “Now with new methods emerging to allow us to properly analyze admixed populations in GWAS studies, we’re making efforts to compile different datasets scattered across different large-scale cohorts,” says Dr. Montalvo-Ortiz. “Our ultimate goal is to conduct the first large-scale LatinX GWAS of psychiatry,” she says.

With these projects, researchers hope that new psychiatric research will produce clinical advances for people historically left on the sidelines of genomic studies. By involving their communities in genomic research, “whatever is going to be developed will also benefit our community,” says Dr. Teferra. “We will not be left out.”

A version of this article first appeared on Medscape.com.

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In combing the genome, scientists can use genetic clues to determine a person’s risk for psychiatric disease and even identify new drug targets. But the benefits of these discoveries will be limited to people of European descent.

Nearly 90% of participants in genome-wide association studies (GWASs), which search for gene variants linked to disease, are of European ancestry. This Eurocentric focus threatens to widen existing disparities in racial and ethnic mental health.

Dr. Solomon Teferra


“If you develop certain interventions based on only a single population profile, then you’ll be leaving out the rest of the populations in the world,” says Solomon Teferra, MD, PhD, associate professor of psychiatry at Addis Ababa University, Ethiopia. In a growing trend, psychiatric researchers are diverging from the field’s European bias and are working to correct the imbalance in DNA databases.

The significant downsides of genomics’ one-track mind

One obstacle hindering therapeutic advances in psychiatry is a shallow understanding of the mechanisms of disorders. “The biggest problem in terms of advancing research for mental health conditions is that we don’t understand the underlying biology,” says Laramie Duncan, PhD, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “Genetics is one of the best ways to systematically look for new clues about the underlying biology.”

At the advent of genomic research, scientists thought it best to study DNA from people of a single ancestry from one continent. “Researchers for a long time held the idea that it was going to be too complicated to include multiple ancestries in the first rounds of genetic analyses,” says Dr. Duncan.

Studying DNA from someone with ancestors from multiple parts of the world wasn’t compatible with methods used in the early days of GWASs. “Individual parts of a person’s DNA can be linked back to one region of the world or another, and most of our methods essentially assume that all of a person’s DNA came from one region of the world,” says Dr. Duncan.

Because many genes are usually involved in psychiatric disorders, scientists need large numbers of participants to detect uncommon, influential variants. Early research was concentrated in North America and Europe so that scientists could readily collect samples from people of European ancestry.

“It then went out of hand because it became routine practice to use only this one group, essentially White, European ancestry people,” says Karoline Kuchenbaecker, PhD, associate professor of psychiatry at University College London.

Yet findings from one population won’t necessarily translate to others. “And that’s exactly what has been shown,” says Dr. Teferra. Polygenic risk scores developed for schizophrenia from European samples, for example, perform poorly among people of African ancestry, although among Europeans, they are strongly effective at differentiating European individuals with and those without schizophrenia. Moreover, drugs that target a gene identified from studies in European populations may be harmful to other groups.

Studies drawn from a diverse pool of participants would benefit a wider swath of humanity. They would also allow scientists to discover small areas of overlap in genomes of different populations, which would help them close in on the true biology of diseases and ensure that “we’re all benefiting from more diverse data in genetics and psychiatric genetics,” says Dr. Kuchenbaecker.
 

 

 

New efforts aim at filling the gaps

Genomic studies are featuring more people of non-European ancestry, but most of that improvement comes from populations of Asian ancestry, not African, Latin American, or Indigenous ancestry.

Efforts to increase representation of persons of African ancestry have largely focused on African Americans; fewer efforts have extended to the African continent, home to the most genetically diverse populations. Even fewer have focused on mental health. “The little that was being done was on a very small scale,” says Karestan Koenen, PhD, a professor at Harvard School of Public Health, Boston.

With this in mind, researchers from institutions in Kenya, Uganda, South Africa, and Ethiopia partnered with researchers at the Broad Institute of the Massachusetts Institute of Technology and Harvard to conduct the largest GWAS of psychiatric disorders in Africa. Dr. Koenen leads the project, Neuropsychiatric Genetics of African Populations–Psychosis (NeuroGAP-Psychosis), which will analyze DNA from over 35,000 people of African ancestry in each of these four countries. Investigators will compare the half of participants who have no history of psychosis with the half with schizophrenia or bipolar disorder in the hopes of identifying the genetic determinants of psychosis.

“Then any potential intervention or therapeutics that will be developed will also be useful for Africans,” says Dr. Teferra, a NeuroGAP principal investigator. Because of the tremendous degree of genetic diversity among people on the continent, however, findings still might not translate to all African populations.

But correcting equity problems in genomics isn’t as simple as recruiting people with non-European backgrounds, especially if those people are unfamiliar with research or have been subject to scientific exploitation. “Special care needs to be taken to, first of all, provide information that’s appropriate [to participants], but also motivate people to take part and then find ways to keep these communities involved and understand what they’re interested in,” says Dr. Kuchenbaecker, who is not involved with NeuroGAP.

For NeuroGAP, the team needed to work with ethical committees at all of the institutions involved, ensure research materials were appropriate for each community’s cultural context, and gain the trust of local communities.

“One of the biggest criticisms within the scientific world is that people from more endowed countries just fly in, bully everyone, collect the data, and leave, with no credit to the local scientists or communities,” says NeuroGAP principal investigator Lukoye Atwoli, MMed, PhD, professor of psychiatry and dean of the Medical College, East Africa, at the Aga Khan University, Nairobi, Kenya. “That is one of the biggest pitfalls we had to grapple with.”

To address that concern, NeuroGAP is training local researchers and is providing them with requested resources so they can carry out similar studies in the future. “We will be looking to address a real need in the academic community and in clinical service delivery,” says Dr. Atwoli.

Dr. Kuchenbaecker says that NeuroGAP demonstrates features necessary for projects seeking to improve equity in psychiatric genomics. “What they’re doing right is recruiting really large numbers, recruiting from different African countries, and involving African investigators,” she says.

In the Americas, Janitza Montalvo-Ortiz, PhD, assistant professor in the Division of Genetics, department of psychiatry, Yale University, New Haven, Conn., and her colleagues are expanding psychiatric genomics projects in Latin America. She co-founded the Latin American Genomics Consortium in 2019, a network of scientists supporting psychiatric genomic research in the region. The consortium also involves the Neuropsychiatric Genetics in Mexican Populations project, which is similar to NeuroGAP and is also led by Dr. Koenan.

The study of Latin American populations is complicated, because genes in these populations reflect Indigenous American, European, and African ancestries. Even when investigators sampled DNA from Latin American individuals, that data often went unused. “Now with new methods emerging to allow us to properly analyze admixed populations in GWAS studies, we’re making efforts to compile different datasets scattered across different large-scale cohorts,” says Dr. Montalvo-Ortiz. “Our ultimate goal is to conduct the first large-scale LatinX GWAS of psychiatry,” she says.

With these projects, researchers hope that new psychiatric research will produce clinical advances for people historically left on the sidelines of genomic studies. By involving their communities in genomic research, “whatever is going to be developed will also benefit our community,” says Dr. Teferra. “We will not be left out.”

A version of this article first appeared on Medscape.com.

 

In combing the genome, scientists can use genetic clues to determine a person’s risk for psychiatric disease and even identify new drug targets. But the benefits of these discoveries will be limited to people of European descent.

Nearly 90% of participants in genome-wide association studies (GWASs), which search for gene variants linked to disease, are of European ancestry. This Eurocentric focus threatens to widen existing disparities in racial and ethnic mental health.

Dr. Solomon Teferra


“If you develop certain interventions based on only a single population profile, then you’ll be leaving out the rest of the populations in the world,” says Solomon Teferra, MD, PhD, associate professor of psychiatry at Addis Ababa University, Ethiopia. In a growing trend, psychiatric researchers are diverging from the field’s European bias and are working to correct the imbalance in DNA databases.

The significant downsides of genomics’ one-track mind

One obstacle hindering therapeutic advances in psychiatry is a shallow understanding of the mechanisms of disorders. “The biggest problem in terms of advancing research for mental health conditions is that we don’t understand the underlying biology,” says Laramie Duncan, PhD, assistant professor of psychiatry and behavioral sciences at Stanford (Calif.) University. “Genetics is one of the best ways to systematically look for new clues about the underlying biology.”

At the advent of genomic research, scientists thought it best to study DNA from people of a single ancestry from one continent. “Researchers for a long time held the idea that it was going to be too complicated to include multiple ancestries in the first rounds of genetic analyses,” says Dr. Duncan.

Studying DNA from someone with ancestors from multiple parts of the world wasn’t compatible with methods used in the early days of GWASs. “Individual parts of a person’s DNA can be linked back to one region of the world or another, and most of our methods essentially assume that all of a person’s DNA came from one region of the world,” says Dr. Duncan.

Because many genes are usually involved in psychiatric disorders, scientists need large numbers of participants to detect uncommon, influential variants. Early research was concentrated in North America and Europe so that scientists could readily collect samples from people of European ancestry.

“It then went out of hand because it became routine practice to use only this one group, essentially White, European ancestry people,” says Karoline Kuchenbaecker, PhD, associate professor of psychiatry at University College London.

Yet findings from one population won’t necessarily translate to others. “And that’s exactly what has been shown,” says Dr. Teferra. Polygenic risk scores developed for schizophrenia from European samples, for example, perform poorly among people of African ancestry, although among Europeans, they are strongly effective at differentiating European individuals with and those without schizophrenia. Moreover, drugs that target a gene identified from studies in European populations may be harmful to other groups.

Studies drawn from a diverse pool of participants would benefit a wider swath of humanity. They would also allow scientists to discover small areas of overlap in genomes of different populations, which would help them close in on the true biology of diseases and ensure that “we’re all benefiting from more diverse data in genetics and psychiatric genetics,” says Dr. Kuchenbaecker.
 

 

 

New efforts aim at filling the gaps

Genomic studies are featuring more people of non-European ancestry, but most of that improvement comes from populations of Asian ancestry, not African, Latin American, or Indigenous ancestry.

Efforts to increase representation of persons of African ancestry have largely focused on African Americans; fewer efforts have extended to the African continent, home to the most genetically diverse populations. Even fewer have focused on mental health. “The little that was being done was on a very small scale,” says Karestan Koenen, PhD, a professor at Harvard School of Public Health, Boston.

With this in mind, researchers from institutions in Kenya, Uganda, South Africa, and Ethiopia partnered with researchers at the Broad Institute of the Massachusetts Institute of Technology and Harvard to conduct the largest GWAS of psychiatric disorders in Africa. Dr. Koenen leads the project, Neuropsychiatric Genetics of African Populations–Psychosis (NeuroGAP-Psychosis), which will analyze DNA from over 35,000 people of African ancestry in each of these four countries. Investigators will compare the half of participants who have no history of psychosis with the half with schizophrenia or bipolar disorder in the hopes of identifying the genetic determinants of psychosis.

“Then any potential intervention or therapeutics that will be developed will also be useful for Africans,” says Dr. Teferra, a NeuroGAP principal investigator. Because of the tremendous degree of genetic diversity among people on the continent, however, findings still might not translate to all African populations.

But correcting equity problems in genomics isn’t as simple as recruiting people with non-European backgrounds, especially if those people are unfamiliar with research or have been subject to scientific exploitation. “Special care needs to be taken to, first of all, provide information that’s appropriate [to participants], but also motivate people to take part and then find ways to keep these communities involved and understand what they’re interested in,” says Dr. Kuchenbaecker, who is not involved with NeuroGAP.

For NeuroGAP, the team needed to work with ethical committees at all of the institutions involved, ensure research materials were appropriate for each community’s cultural context, and gain the trust of local communities.

“One of the biggest criticisms within the scientific world is that people from more endowed countries just fly in, bully everyone, collect the data, and leave, with no credit to the local scientists or communities,” says NeuroGAP principal investigator Lukoye Atwoli, MMed, PhD, professor of psychiatry and dean of the Medical College, East Africa, at the Aga Khan University, Nairobi, Kenya. “That is one of the biggest pitfalls we had to grapple with.”

To address that concern, NeuroGAP is training local researchers and is providing them with requested resources so they can carry out similar studies in the future. “We will be looking to address a real need in the academic community and in clinical service delivery,” says Dr. Atwoli.

Dr. Kuchenbaecker says that NeuroGAP demonstrates features necessary for projects seeking to improve equity in psychiatric genomics. “What they’re doing right is recruiting really large numbers, recruiting from different African countries, and involving African investigators,” she says.

In the Americas, Janitza Montalvo-Ortiz, PhD, assistant professor in the Division of Genetics, department of psychiatry, Yale University, New Haven, Conn., and her colleagues are expanding psychiatric genomics projects in Latin America. She co-founded the Latin American Genomics Consortium in 2019, a network of scientists supporting psychiatric genomic research in the region. The consortium also involves the Neuropsychiatric Genetics in Mexican Populations project, which is similar to NeuroGAP and is also led by Dr. Koenan.

The study of Latin American populations is complicated, because genes in these populations reflect Indigenous American, European, and African ancestries. Even when investigators sampled DNA from Latin American individuals, that data often went unused. “Now with new methods emerging to allow us to properly analyze admixed populations in GWAS studies, we’re making efforts to compile different datasets scattered across different large-scale cohorts,” says Dr. Montalvo-Ortiz. “Our ultimate goal is to conduct the first large-scale LatinX GWAS of psychiatry,” she says.

With these projects, researchers hope that new psychiatric research will produce clinical advances for people historically left on the sidelines of genomic studies. By involving their communities in genomic research, “whatever is going to be developed will also benefit our community,” says Dr. Teferra. “We will not be left out.”

A version of this article first appeared on Medscape.com.

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State-of-the-art psych unit designed with recovery in mind

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Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Dr. Sarah Edwards


“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.

Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.

The pandemic has added to the already stressful circumstances that many youth in Baltimore and elsewhere face, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.

“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Dr. Jill RachBeisel


Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.

“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.

Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

“We offer a really warm and welcoming environment that we think is going to promote health and healing,” said the unit’s head, Dr. Sarah Edwards.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

Unique elements of the new unit include walls painted soothing shades.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

A version of this article first appeared on Medscape.com.

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Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Dr. Sarah Edwards


“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.

Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.

The pandemic has added to the already stressful circumstances that many youth in Baltimore and elsewhere face, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.

“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Dr. Jill RachBeisel


Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.

“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.

Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

“We offer a really warm and welcoming environment that we think is going to promote health and healing,” said the unit’s head, Dr. Sarah Edwards.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

Unique elements of the new unit include walls painted soothing shades.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

A version of this article first appeared on Medscape.com.

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Dr. Sarah Edwards


“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.

Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.

The pandemic has added to the already stressful circumstances that many youth in Baltimore and elsewhere face, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.

“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Dr. Jill RachBeisel


Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.

“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.

Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

“We offer a really warm and welcoming environment that we think is going to promote health and healing,” said the unit’s head, Dr. Sarah Edwards.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

Unique elements of the new unit include walls painted soothing shades.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

A version of this article first appeared on Medscape.com.

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Britney Spears and her 13-year conservatorship: An abuse of involuntary care?

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The public has watched the ongoing drama unfold in the media for the past 13 years. In 2008, pop star Britney Spears was placed on conservatorship – a court process that gave decision-making powers over her personal, legal, and financial decisions to another person.

On June 23, 2021, Ms. Spears announced in open court that she is traumatized by being conserved and wants her rights back, but we know little about what behaviors left her family and a judge to determine that she was not capable of managing her own affairs, and why this would remain the case for so many years. This is an important conversation for those interested in involuntary care.

Adam Nelson, MD, practices psychiatry in Marin County, Calif. He explained in an interview that there are different types of conservatorships. “Probate conservatorship is the traditional path for conservatorship of person, estate, and/or finances based on evidence of incapacity due to any medical condition. This is the type of conservatorship that Britney Spears has had and which she is now contesting.”

Ms. Spears was placed on conservatorship after two involuntary hospitalizations for psychiatric illness and/or substance abuse. Her father, Jamie Spears, was appointed by the court to be her conservator.

In a New York Times article, reporters Liz Day, Samantha Stark, and Joe Coscarelli recently wrote: “But now, confidential court records obtained by the New York Times reveal that Ms. Spears, 39, expressed serious opposition to the conservatorship earlier and more often than had previously been known, and said that it restricted everything from whom she dated to the color of her kitchen cabinets.” The article goes on to say: “The newly obtained court records show that Ms. Spears questioned [her father’s] fitness for the role. As early as 2014, in a hearing closed to the public, Ms. Spears’s court-appointed lawyer, Samuel D. Ingham III, said she wanted to explore removing her father as conservator, citing his drinking, among other objections on a ‘shopping list’ of grievances.

“As the fight drags on, the bills are piling up – and, in a quirk of the conservatorship system, Ms. Spears has to pay for lawyers on both sides, including those arguing against her wishes in court. A recent $890,000 bill from one set of Mr. Spears’s lawyers, covering about 4 months of work, included media strategizing for defending the conservatorship.”

The case heated up at the June 23 hearing, when Ms. Spears had a telephone hearing with Los Angeles probate Judge Brenda Penney. The call was transcribed and published in Variety. The purpose of the hearing was for Ms. Spears to request an expedited release from her conservatorship without a psychiatric evaluation.

Ms. Spears began her 23-minute testimony to the judge by discussing her work and how she felt compelled to perform. “My management said, if I don’t do this tour, I will have to find an attorney, and by contract my own management could sue me if I didn’t follow through with the tour. ... So out of fear, I went ahead and I did the tour.”

She then discussed concerns by her manager that she was not complying with her medication regimen.

“Three days later, after I said no to Vegas,” Ms. Spears continued, “my therapist sat me down in a room and said he had a million phone calls about how I was not cooperating in rehearsals, and I haven’t been taking my medication. All this was false. He immediately, the next day, put me on lithium out of nowhere. He took me off my normal meds I’ve been on for 5 years. ... There were six different nurses in my home and they wouldn’t let me get in my car to go anywhere for a month.”

She spoke about entering rehab at the insistence of the conservatorship, and relayed her distress about this experience. She talked poignantly about her frustration of feeling she was not being heard by the court the last time she spoke and about the financial conflicts of interest created by her conservatorship. Ms. Spears, who has appeared on national television, recorded albums, and gone on performance tours during this period, has a net worth estimated at $60 million.

“It’s been a long time since I’ve owned my money. And it’s my wish and my dream for all of this to end without being tested,” she told the judge. “Again, it makes no sense whatsoever for the state of California to sit back and literally watch me with their own two eyes, make a living for so many people, and pay so many people trucks and buses on the road with me and be told, I’m not good enough. But I’m great at what I do. And I allow these people to control what I do, ma’am. And it’s enough. It makes no sense at all.”

Finally, Ms. Spears expressed a heart-wrenching desire to have another child and she asserted that the conservatorship will not allow her to see a doctor to have her IUD removed. She talked about being required to go to therapy three times a week and contended that she is traumatized by all that has transpired.

Ms. Spears has not filed the necessary paperwork to have her conservatorship ended. In an interview with Vice, attorney Scott Rahn noted that the process to end conservatorship can be a lengthy and difficult path. To do so, she might first need to petition the court to be allowed to hire her own attorney. If uncontested, the conservatorship could possibly be ended within months, but otherwise this could entail a lengthy trial over the course of years. While ending conservatorship may entail discovery, depositions, and hearings over years, a scathing story in the New Yorker detailed how Ms. Spears was placed into this conservatorship in a matter of days, without being present to give her own testimony. In the usual circumstances, California law requires that the person being conserved must be given 5 days’ notice before a conservatorship takes place, but Ms. Spears was deemed to be at risk of substantial harm and the judge allowed for an immediate conservatorship. The article notes that even axe murderers are allowed to hire lawyers, while those placed in conservatorships are not.


 

Reasoning behind such actions

Often, people are appointed guardians, conservators, or payees because of concerns that their psychiatric or substance use disorders, dementia, or impaired intellectual states lead them to poor decisions that endanger their financial stability. Usually the money they may lose is from a government disability benefit, an inheritance, or former accrued wealth. In this unusual celebrity case, Britney Spears has been conserved while she maintained a rigorous work schedule and actively earned the money she is being protected from spending.

Dr. Dinah Miller

Dr. Nelson talked about how people come to be conserved. “The law regarding conservatorship is a state law, but conservatorships in California are done at the county level, and the counties don’t have a vested interest in protecting people from themselves unless a third party or a family member comes forward. I imagine there is another side to this story, I have never seen it used like this for someone who is working. Questions remain about why this conservatorship has gone on for 13 years.”

Dr. Nelson believes that the current California laws leave room for abuse. “If the children of a wealthy parent observes the parent spending their inheritance in a way they don’t approve of, they can claim the parent is impaired and needs to be conserved. Usually it doesn’t work, but it’s possible there are times when the courts are swayed.”

Why does it matter and why should psychiatrists be concerned? The issue of involuntary treatment is a contentious one, and the stakeholders on all sides are vocal when it comes to our country’s sickest and most vulnerable individuals. Any story with a whiff of abuse, or of someone who is not severely impaired being denied basic civil rights – including the right to refuse treatment – dilutes and stains the efforts of those who are trying to protect people who suffer from chronic psychotic disorders. And when society reaches further to say that an individual is not entitled to make their own basic life decisions, this further stigmatizes those with psychiatric illnesses. And people with both mental illnesses and substance use disorders often get better, so why would conservatorships be permanent?

Does our society want the courts to protect people from their own poor judgment? Should there be judges at every casino entrance? Where are the conservators for those who live in the streets? Again, this is a half-told story, one where the potential for abuse of the conserved remains a high risk, and the long-term message about involuntary care is one of taking a way a person’s rights unnecessarily.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. She has no disclosures.

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The public has watched the ongoing drama unfold in the media for the past 13 years. In 2008, pop star Britney Spears was placed on conservatorship – a court process that gave decision-making powers over her personal, legal, and financial decisions to another person.

On June 23, 2021, Ms. Spears announced in open court that she is traumatized by being conserved and wants her rights back, but we know little about what behaviors left her family and a judge to determine that she was not capable of managing her own affairs, and why this would remain the case for so many years. This is an important conversation for those interested in involuntary care.

Adam Nelson, MD, practices psychiatry in Marin County, Calif. He explained in an interview that there are different types of conservatorships. “Probate conservatorship is the traditional path for conservatorship of person, estate, and/or finances based on evidence of incapacity due to any medical condition. This is the type of conservatorship that Britney Spears has had and which she is now contesting.”

Ms. Spears was placed on conservatorship after two involuntary hospitalizations for psychiatric illness and/or substance abuse. Her father, Jamie Spears, was appointed by the court to be her conservator.

In a New York Times article, reporters Liz Day, Samantha Stark, and Joe Coscarelli recently wrote: “But now, confidential court records obtained by the New York Times reveal that Ms. Spears, 39, expressed serious opposition to the conservatorship earlier and more often than had previously been known, and said that it restricted everything from whom she dated to the color of her kitchen cabinets.” The article goes on to say: “The newly obtained court records show that Ms. Spears questioned [her father’s] fitness for the role. As early as 2014, in a hearing closed to the public, Ms. Spears’s court-appointed lawyer, Samuel D. Ingham III, said she wanted to explore removing her father as conservator, citing his drinking, among other objections on a ‘shopping list’ of grievances.

“As the fight drags on, the bills are piling up – and, in a quirk of the conservatorship system, Ms. Spears has to pay for lawyers on both sides, including those arguing against her wishes in court. A recent $890,000 bill from one set of Mr. Spears’s lawyers, covering about 4 months of work, included media strategizing for defending the conservatorship.”

The case heated up at the June 23 hearing, when Ms. Spears had a telephone hearing with Los Angeles probate Judge Brenda Penney. The call was transcribed and published in Variety. The purpose of the hearing was for Ms. Spears to request an expedited release from her conservatorship without a psychiatric evaluation.

Ms. Spears began her 23-minute testimony to the judge by discussing her work and how she felt compelled to perform. “My management said, if I don’t do this tour, I will have to find an attorney, and by contract my own management could sue me if I didn’t follow through with the tour. ... So out of fear, I went ahead and I did the tour.”

She then discussed concerns by her manager that she was not complying with her medication regimen.

“Three days later, after I said no to Vegas,” Ms. Spears continued, “my therapist sat me down in a room and said he had a million phone calls about how I was not cooperating in rehearsals, and I haven’t been taking my medication. All this was false. He immediately, the next day, put me on lithium out of nowhere. He took me off my normal meds I’ve been on for 5 years. ... There were six different nurses in my home and they wouldn’t let me get in my car to go anywhere for a month.”

She spoke about entering rehab at the insistence of the conservatorship, and relayed her distress about this experience. She talked poignantly about her frustration of feeling she was not being heard by the court the last time she spoke and about the financial conflicts of interest created by her conservatorship. Ms. Spears, who has appeared on national television, recorded albums, and gone on performance tours during this period, has a net worth estimated at $60 million.

“It’s been a long time since I’ve owned my money. And it’s my wish and my dream for all of this to end without being tested,” she told the judge. “Again, it makes no sense whatsoever for the state of California to sit back and literally watch me with their own two eyes, make a living for so many people, and pay so many people trucks and buses on the road with me and be told, I’m not good enough. But I’m great at what I do. And I allow these people to control what I do, ma’am. And it’s enough. It makes no sense at all.”

Finally, Ms. Spears expressed a heart-wrenching desire to have another child and she asserted that the conservatorship will not allow her to see a doctor to have her IUD removed. She talked about being required to go to therapy three times a week and contended that she is traumatized by all that has transpired.

Ms. Spears has not filed the necessary paperwork to have her conservatorship ended. In an interview with Vice, attorney Scott Rahn noted that the process to end conservatorship can be a lengthy and difficult path. To do so, she might first need to petition the court to be allowed to hire her own attorney. If uncontested, the conservatorship could possibly be ended within months, but otherwise this could entail a lengthy trial over the course of years. While ending conservatorship may entail discovery, depositions, and hearings over years, a scathing story in the New Yorker detailed how Ms. Spears was placed into this conservatorship in a matter of days, without being present to give her own testimony. In the usual circumstances, California law requires that the person being conserved must be given 5 days’ notice before a conservatorship takes place, but Ms. Spears was deemed to be at risk of substantial harm and the judge allowed for an immediate conservatorship. The article notes that even axe murderers are allowed to hire lawyers, while those placed in conservatorships are not.


 

Reasoning behind such actions

Often, people are appointed guardians, conservators, or payees because of concerns that their psychiatric or substance use disorders, dementia, or impaired intellectual states lead them to poor decisions that endanger their financial stability. Usually the money they may lose is from a government disability benefit, an inheritance, or former accrued wealth. In this unusual celebrity case, Britney Spears has been conserved while she maintained a rigorous work schedule and actively earned the money she is being protected from spending.

Dr. Dinah Miller

Dr. Nelson talked about how people come to be conserved. “The law regarding conservatorship is a state law, but conservatorships in California are done at the county level, and the counties don’t have a vested interest in protecting people from themselves unless a third party or a family member comes forward. I imagine there is another side to this story, I have never seen it used like this for someone who is working. Questions remain about why this conservatorship has gone on for 13 years.”

Dr. Nelson believes that the current California laws leave room for abuse. “If the children of a wealthy parent observes the parent spending their inheritance in a way they don’t approve of, they can claim the parent is impaired and needs to be conserved. Usually it doesn’t work, but it’s possible there are times when the courts are swayed.”

Why does it matter and why should psychiatrists be concerned? The issue of involuntary treatment is a contentious one, and the stakeholders on all sides are vocal when it comes to our country’s sickest and most vulnerable individuals. Any story with a whiff of abuse, or of someone who is not severely impaired being denied basic civil rights – including the right to refuse treatment – dilutes and stains the efforts of those who are trying to protect people who suffer from chronic psychotic disorders. And when society reaches further to say that an individual is not entitled to make their own basic life decisions, this further stigmatizes those with psychiatric illnesses. And people with both mental illnesses and substance use disorders often get better, so why would conservatorships be permanent?

Does our society want the courts to protect people from their own poor judgment? Should there be judges at every casino entrance? Where are the conservators for those who live in the streets? Again, this is a half-told story, one where the potential for abuse of the conserved remains a high risk, and the long-term message about involuntary care is one of taking a way a person’s rights unnecessarily.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. She has no disclosures.

 

The public has watched the ongoing drama unfold in the media for the past 13 years. In 2008, pop star Britney Spears was placed on conservatorship – a court process that gave decision-making powers over her personal, legal, and financial decisions to another person.

On June 23, 2021, Ms. Spears announced in open court that she is traumatized by being conserved and wants her rights back, but we know little about what behaviors left her family and a judge to determine that she was not capable of managing her own affairs, and why this would remain the case for so many years. This is an important conversation for those interested in involuntary care.

Adam Nelson, MD, practices psychiatry in Marin County, Calif. He explained in an interview that there are different types of conservatorships. “Probate conservatorship is the traditional path for conservatorship of person, estate, and/or finances based on evidence of incapacity due to any medical condition. This is the type of conservatorship that Britney Spears has had and which she is now contesting.”

Ms. Spears was placed on conservatorship after two involuntary hospitalizations for psychiatric illness and/or substance abuse. Her father, Jamie Spears, was appointed by the court to be her conservator.

In a New York Times article, reporters Liz Day, Samantha Stark, and Joe Coscarelli recently wrote: “But now, confidential court records obtained by the New York Times reveal that Ms. Spears, 39, expressed serious opposition to the conservatorship earlier and more often than had previously been known, and said that it restricted everything from whom she dated to the color of her kitchen cabinets.” The article goes on to say: “The newly obtained court records show that Ms. Spears questioned [her father’s] fitness for the role. As early as 2014, in a hearing closed to the public, Ms. Spears’s court-appointed lawyer, Samuel D. Ingham III, said she wanted to explore removing her father as conservator, citing his drinking, among other objections on a ‘shopping list’ of grievances.

“As the fight drags on, the bills are piling up – and, in a quirk of the conservatorship system, Ms. Spears has to pay for lawyers on both sides, including those arguing against her wishes in court. A recent $890,000 bill from one set of Mr. Spears’s lawyers, covering about 4 months of work, included media strategizing for defending the conservatorship.”

The case heated up at the June 23 hearing, when Ms. Spears had a telephone hearing with Los Angeles probate Judge Brenda Penney. The call was transcribed and published in Variety. The purpose of the hearing was for Ms. Spears to request an expedited release from her conservatorship without a psychiatric evaluation.

Ms. Spears began her 23-minute testimony to the judge by discussing her work and how she felt compelled to perform. “My management said, if I don’t do this tour, I will have to find an attorney, and by contract my own management could sue me if I didn’t follow through with the tour. ... So out of fear, I went ahead and I did the tour.”

She then discussed concerns by her manager that she was not complying with her medication regimen.

“Three days later, after I said no to Vegas,” Ms. Spears continued, “my therapist sat me down in a room and said he had a million phone calls about how I was not cooperating in rehearsals, and I haven’t been taking my medication. All this was false. He immediately, the next day, put me on lithium out of nowhere. He took me off my normal meds I’ve been on for 5 years. ... There were six different nurses in my home and they wouldn’t let me get in my car to go anywhere for a month.”

She spoke about entering rehab at the insistence of the conservatorship, and relayed her distress about this experience. She talked poignantly about her frustration of feeling she was not being heard by the court the last time she spoke and about the financial conflicts of interest created by her conservatorship. Ms. Spears, who has appeared on national television, recorded albums, and gone on performance tours during this period, has a net worth estimated at $60 million.

“It’s been a long time since I’ve owned my money. And it’s my wish and my dream for all of this to end without being tested,” she told the judge. “Again, it makes no sense whatsoever for the state of California to sit back and literally watch me with their own two eyes, make a living for so many people, and pay so many people trucks and buses on the road with me and be told, I’m not good enough. But I’m great at what I do. And I allow these people to control what I do, ma’am. And it’s enough. It makes no sense at all.”

Finally, Ms. Spears expressed a heart-wrenching desire to have another child and she asserted that the conservatorship will not allow her to see a doctor to have her IUD removed. She talked about being required to go to therapy three times a week and contended that she is traumatized by all that has transpired.

Ms. Spears has not filed the necessary paperwork to have her conservatorship ended. In an interview with Vice, attorney Scott Rahn noted that the process to end conservatorship can be a lengthy and difficult path. To do so, she might first need to petition the court to be allowed to hire her own attorney. If uncontested, the conservatorship could possibly be ended within months, but otherwise this could entail a lengthy trial over the course of years. While ending conservatorship may entail discovery, depositions, and hearings over years, a scathing story in the New Yorker detailed how Ms. Spears was placed into this conservatorship in a matter of days, without being present to give her own testimony. In the usual circumstances, California law requires that the person being conserved must be given 5 days’ notice before a conservatorship takes place, but Ms. Spears was deemed to be at risk of substantial harm and the judge allowed for an immediate conservatorship. The article notes that even axe murderers are allowed to hire lawyers, while those placed in conservatorships are not.


 

Reasoning behind such actions

Often, people are appointed guardians, conservators, or payees because of concerns that their psychiatric or substance use disorders, dementia, or impaired intellectual states lead them to poor decisions that endanger their financial stability. Usually the money they may lose is from a government disability benefit, an inheritance, or former accrued wealth. In this unusual celebrity case, Britney Spears has been conserved while she maintained a rigorous work schedule and actively earned the money she is being protected from spending.

Dr. Dinah Miller

Dr. Nelson talked about how people come to be conserved. “The law regarding conservatorship is a state law, but conservatorships in California are done at the county level, and the counties don’t have a vested interest in protecting people from themselves unless a third party or a family member comes forward. I imagine there is another side to this story, I have never seen it used like this for someone who is working. Questions remain about why this conservatorship has gone on for 13 years.”

Dr. Nelson believes that the current California laws leave room for abuse. “If the children of a wealthy parent observes the parent spending their inheritance in a way they don’t approve of, they can claim the parent is impaired and needs to be conserved. Usually it doesn’t work, but it’s possible there are times when the courts are swayed.”

Why does it matter and why should psychiatrists be concerned? The issue of involuntary treatment is a contentious one, and the stakeholders on all sides are vocal when it comes to our country’s sickest and most vulnerable individuals. Any story with a whiff of abuse, or of someone who is not severely impaired being denied basic civil rights – including the right to refuse treatment – dilutes and stains the efforts of those who are trying to protect people who suffer from chronic psychotic disorders. And when society reaches further to say that an individual is not entitled to make their own basic life decisions, this further stigmatizes those with psychiatric illnesses. And people with both mental illnesses and substance use disorders often get better, so why would conservatorships be permanent?

Does our society want the courts to protect people from their own poor judgment? Should there be judges at every casino entrance? Where are the conservators for those who live in the streets? Again, this is a half-told story, one where the potential for abuse of the conserved remains a high risk, and the long-term message about involuntary care is one of taking a way a person’s rights unnecessarily.

Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. She has no disclosures.

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More on long-acting injectable antipsychotics

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More on long-acting injectable antipsychotics

Benefits of early LAI use

I want to thank Dr. Nasrallah for his editorial calling for more frequent and earlier use of long-acting injectable antipsychotics (LAIs) in schizophrenia (From the Editor, Current Psychiatry, May 2021, p. 9-12). I consider LAIs to be lifesaving interventions, so I’ve offered LAI administration via a drive-up service over the past year to ensure patients could continue to receive their treatment, even through the worst times of the COVID-19 pandemic.1 LAIs can be beneficial for anyone living with schizophrenia, but are never more important than in first-episode psychosis (FEP), when repeated psychotic relapses have not yet ravaged the brain. Earlier aggressive treatment of FEP and subsequent relapses with LAIs can dramatically improve long-term outcomes for people with schizophrenia.

In addition to the neuroprotective biologic effects of early LAI usage, I’ve found that many of my FEP patients find great psychological comfort from incorporating LAIs into their treatment plan. The first psychotic break is generally when a person (and their family) feels the most afraid about the future and is in desperate need of hope that they can have a full life—with educational opportunities, sustained employment, meaningful relationships, and more. Just as society has seen the COVID-19 vaccines as a symbol of hope and the first step in overcoming the oppression of living in fear of an uncertain future, we need to help people experiencing FEP find hope in a needle.

Craig Chepke, MD, FAPA
Excel Psychiatric Associates
Huntersville, North Carolina

Reference

1. Chepke C. Drive-up pharmacotherapy during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):29-30.

Dr. Nasrallah responds

Thank you, Dr. Chepke, for your letter confirming full support for using LAIs in schizophrenia. I like the phrase you coined: “hope in a needle.” The early use of LAIs in schizophrenia can provide the same type of hope that the vaccines against the life-threatening COVID-19 virus have generated in our society. Based on my direct observations, I also agree with you that the longer patients with schizophrenia remain on LAIs, the more engaged and happy they are with their progress and the quality of their lives. It is tragic that many patients never had the opportunity to return to their baseline with the early use of LAIs immediately following their first psychotic episode, instead of relapsing again and again due to their inability to adhere completely to their oral medications.

Henry A. Nasrallah, MD
Editor-In-Chief

Continue to: LAIs as the standard of care

 

 

LAIs as the standard of care

Thank you, Dr. Nasrallah, for reiterating the importance of compliance with pharmacologic management of schizophrenia after FEP (From the Editor, Current Psychiatry, May 2021, p. 9-12). Long before LAIs, I appreciated the successes patients with schizophrenia experienced when they complied with treatment after the first episode. It was clear that success was forthcoming for patients who had an interested psychiatrist and a committed relationship with them.

As you point out in your editorial, the facts are powerful, well-known, undisputed, and yet not adopted in the United States, when in other countries LAIs are first-line care. Yes, LAIs are expensive, but not nearly as expensive as the disabilities caused by noncompliance are to society.

Why isn’t LAI use the standard of care here in the United States? In the United States, there is advocacy for treatment because there’s money in it. There is no good advocacy for preventive care because there’s no immediate money in it. We have another good example of this in the United States: private, for-profit prisons. They have a vested interest in keeping prisons full and building new ones. Patients with FEP are most often treated in the hospital, where a standard of care could easily be established that mandates LAIs as first-tier care. Why is that not so? Who is pushing for it? Who is resisting?

Your editorial inspired me to advocate more strongly. Do you have advice about how to effect policy change? I know administrators respond when we talk dollars and cents, not quality of care. What is the dollar cost of not using LAIs as the standard of care after FEP? Who cares? Who would listen to the numbers?

Edward A. Major, MD, LFAPA
Clinical Professor of Psychiatry
Upstate Medical Center
Syracuse, New York

Dr. Nasrallah responds

Dr. Major, thanks for your message. Establishing a standard of care for the use of LAIs (or any other therapy) is not that simple. It requires well-coordinated collaboration among several stakeholders (clinicians, researchers, payors, advocacy groups, and a national organization such as the American Psychiatric Association). The cost issue is certainly powerful, but the equation works in favor of LAIs because 1 psychiatric hospitalization due to a psychotic relapse costs up to 3 times the annual cost of an LAI medication that can prevent that rehospitalization. In addition, disability comprises the lion’s share of the large indirect costs of schizophrenia (disability payments, lifetime room and board, incarceration and legal costs, and loss of work and generation of taxes). LAIs can save both lives and expenditures, and a lot of suffering by patients and their families. I, too, long to see the emergence of a rational standard of care for schizophrenia using LAIs right after the initial psychotic episode. Oncology and cardiology have standards of care, so why not psychiatry?

Henry A. Nasrallah, MD
Editor-In-Chief

Continue to: Psychosis and epilepsy

 

 

Psychosis and epilepsy

I just read your editorial regarding the devastating consequences of psychotic relapses (From the Editor, Current Psychiatry, May 2021, p. 9-12). I was shocked to read of the extent of the damage caused by such relapses and the positive impact of LAIs, and I thank you for opening my eyes. 

I work in the spheres of psychiatry, epileptology, and whole genome sequencing, and have experienced a psychotic episode myself (in 2013, after temporal lobe resection and overdose). I now consider myself even more lucky to be out the other side! As Governor for South London and Maudsley NHS Foundation Trust (SLaM) and Trustee for Epilepsy Action, many of our patients have psychosis. Some patients with epilepsy even experience postictal psychosis. Just yesterday, we had a call at SLaM regarding patients from a secure unit, and a psychiatric nurse spoke about patients at risk to themselves and others because of their psychotic illness, and how crucial effective long-term care was.

Torie Robinson
CEO, Epilepsy Sparks

 

Dr. Nasrallah responds

Ms. Robinson, thank you for sharing your story. It is important to note that the neuro­biology of the psychosis that may occur with epilepsy may not be as neurodegenerative as the psychosis of schizophrenia. Many neurologic conditions can be associated with psychotic episodes, not only epilepsy. I am glad you overcame your post-temporal lobectomy psychotic episode and have had a very good outcome with high functioning.

Henry A. Nasrallah, MD
Editor-In-Chief

Disclosures
Dr. Chepke is a consultant to and speaker for Janssen Pharmaceuticals, Otsuka Pharmaceuticals, and Alkermes. The other authors report no financial relationships with any companies whose products are mentioned in their letters, or with manufacturers of competing products.

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Benefits of early LAI use

I want to thank Dr. Nasrallah for his editorial calling for more frequent and earlier use of long-acting injectable antipsychotics (LAIs) in schizophrenia (From the Editor, Current Psychiatry, May 2021, p. 9-12). I consider LAIs to be lifesaving interventions, so I’ve offered LAI administration via a drive-up service over the past year to ensure patients could continue to receive their treatment, even through the worst times of the COVID-19 pandemic.1 LAIs can be beneficial for anyone living with schizophrenia, but are never more important than in first-episode psychosis (FEP), when repeated psychotic relapses have not yet ravaged the brain. Earlier aggressive treatment of FEP and subsequent relapses with LAIs can dramatically improve long-term outcomes for people with schizophrenia.

In addition to the neuroprotective biologic effects of early LAI usage, I’ve found that many of my FEP patients find great psychological comfort from incorporating LAIs into their treatment plan. The first psychotic break is generally when a person (and their family) feels the most afraid about the future and is in desperate need of hope that they can have a full life—with educational opportunities, sustained employment, meaningful relationships, and more. Just as society has seen the COVID-19 vaccines as a symbol of hope and the first step in overcoming the oppression of living in fear of an uncertain future, we need to help people experiencing FEP find hope in a needle.

Craig Chepke, MD, FAPA
Excel Psychiatric Associates
Huntersville, North Carolina

Reference

1. Chepke C. Drive-up pharmacotherapy during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):29-30.

Dr. Nasrallah responds

Thank you, Dr. Chepke, for your letter confirming full support for using LAIs in schizophrenia. I like the phrase you coined: “hope in a needle.” The early use of LAIs in schizophrenia can provide the same type of hope that the vaccines against the life-threatening COVID-19 virus have generated in our society. Based on my direct observations, I also agree with you that the longer patients with schizophrenia remain on LAIs, the more engaged and happy they are with their progress and the quality of their lives. It is tragic that many patients never had the opportunity to return to their baseline with the early use of LAIs immediately following their first psychotic episode, instead of relapsing again and again due to their inability to adhere completely to their oral medications.

Henry A. Nasrallah, MD
Editor-In-Chief

Continue to: LAIs as the standard of care

 

 

LAIs as the standard of care

Thank you, Dr. Nasrallah, for reiterating the importance of compliance with pharmacologic management of schizophrenia after FEP (From the Editor, Current Psychiatry, May 2021, p. 9-12). Long before LAIs, I appreciated the successes patients with schizophrenia experienced when they complied with treatment after the first episode. It was clear that success was forthcoming for patients who had an interested psychiatrist and a committed relationship with them.

As you point out in your editorial, the facts are powerful, well-known, undisputed, and yet not adopted in the United States, when in other countries LAIs are first-line care. Yes, LAIs are expensive, but not nearly as expensive as the disabilities caused by noncompliance are to society.

Why isn’t LAI use the standard of care here in the United States? In the United States, there is advocacy for treatment because there’s money in it. There is no good advocacy for preventive care because there’s no immediate money in it. We have another good example of this in the United States: private, for-profit prisons. They have a vested interest in keeping prisons full and building new ones. Patients with FEP are most often treated in the hospital, where a standard of care could easily be established that mandates LAIs as first-tier care. Why is that not so? Who is pushing for it? Who is resisting?

Your editorial inspired me to advocate more strongly. Do you have advice about how to effect policy change? I know administrators respond when we talk dollars and cents, not quality of care. What is the dollar cost of not using LAIs as the standard of care after FEP? Who cares? Who would listen to the numbers?

Edward A. Major, MD, LFAPA
Clinical Professor of Psychiatry
Upstate Medical Center
Syracuse, New York

Dr. Nasrallah responds

Dr. Major, thanks for your message. Establishing a standard of care for the use of LAIs (or any other therapy) is not that simple. It requires well-coordinated collaboration among several stakeholders (clinicians, researchers, payors, advocacy groups, and a national organization such as the American Psychiatric Association). The cost issue is certainly powerful, but the equation works in favor of LAIs because 1 psychiatric hospitalization due to a psychotic relapse costs up to 3 times the annual cost of an LAI medication that can prevent that rehospitalization. In addition, disability comprises the lion’s share of the large indirect costs of schizophrenia (disability payments, lifetime room and board, incarceration and legal costs, and loss of work and generation of taxes). LAIs can save both lives and expenditures, and a lot of suffering by patients and their families. I, too, long to see the emergence of a rational standard of care for schizophrenia using LAIs right after the initial psychotic episode. Oncology and cardiology have standards of care, so why not psychiatry?

Henry A. Nasrallah, MD
Editor-In-Chief

Continue to: Psychosis and epilepsy

 

 

Psychosis and epilepsy

I just read your editorial regarding the devastating consequences of psychotic relapses (From the Editor, Current Psychiatry, May 2021, p. 9-12). I was shocked to read of the extent of the damage caused by such relapses and the positive impact of LAIs, and I thank you for opening my eyes. 

I work in the spheres of psychiatry, epileptology, and whole genome sequencing, and have experienced a psychotic episode myself (in 2013, after temporal lobe resection and overdose). I now consider myself even more lucky to be out the other side! As Governor for South London and Maudsley NHS Foundation Trust (SLaM) and Trustee for Epilepsy Action, many of our patients have psychosis. Some patients with epilepsy even experience postictal psychosis. Just yesterday, we had a call at SLaM regarding patients from a secure unit, and a psychiatric nurse spoke about patients at risk to themselves and others because of their psychotic illness, and how crucial effective long-term care was.

Torie Robinson
CEO, Epilepsy Sparks

 

Dr. Nasrallah responds

Ms. Robinson, thank you for sharing your story. It is important to note that the neuro­biology of the psychosis that may occur with epilepsy may not be as neurodegenerative as the psychosis of schizophrenia. Many neurologic conditions can be associated with psychotic episodes, not only epilepsy. I am glad you overcame your post-temporal lobectomy psychotic episode and have had a very good outcome with high functioning.

Henry A. Nasrallah, MD
Editor-In-Chief

Disclosures
Dr. Chepke is a consultant to and speaker for Janssen Pharmaceuticals, Otsuka Pharmaceuticals, and Alkermes. The other authors report no financial relationships with any companies whose products are mentioned in their letters, or with manufacturers of competing products.

Benefits of early LAI use

I want to thank Dr. Nasrallah for his editorial calling for more frequent and earlier use of long-acting injectable antipsychotics (LAIs) in schizophrenia (From the Editor, Current Psychiatry, May 2021, p. 9-12). I consider LAIs to be lifesaving interventions, so I’ve offered LAI administration via a drive-up service over the past year to ensure patients could continue to receive their treatment, even through the worst times of the COVID-19 pandemic.1 LAIs can be beneficial for anyone living with schizophrenia, but are never more important than in first-episode psychosis (FEP), when repeated psychotic relapses have not yet ravaged the brain. Earlier aggressive treatment of FEP and subsequent relapses with LAIs can dramatically improve long-term outcomes for people with schizophrenia.

In addition to the neuroprotective biologic effects of early LAI usage, I’ve found that many of my FEP patients find great psychological comfort from incorporating LAIs into their treatment plan. The first psychotic break is generally when a person (and their family) feels the most afraid about the future and is in desperate need of hope that they can have a full life—with educational opportunities, sustained employment, meaningful relationships, and more. Just as society has seen the COVID-19 vaccines as a symbol of hope and the first step in overcoming the oppression of living in fear of an uncertain future, we need to help people experiencing FEP find hope in a needle.

Craig Chepke, MD, FAPA
Excel Psychiatric Associates
Huntersville, North Carolina

Reference

1. Chepke C. Drive-up pharmacotherapy during the COVID-19 pandemic. Current Psychiatry. 2020;19(5):29-30.

Dr. Nasrallah responds

Thank you, Dr. Chepke, for your letter confirming full support for using LAIs in schizophrenia. I like the phrase you coined: “hope in a needle.” The early use of LAIs in schizophrenia can provide the same type of hope that the vaccines against the life-threatening COVID-19 virus have generated in our society. Based on my direct observations, I also agree with you that the longer patients with schizophrenia remain on LAIs, the more engaged and happy they are with their progress and the quality of their lives. It is tragic that many patients never had the opportunity to return to their baseline with the early use of LAIs immediately following their first psychotic episode, instead of relapsing again and again due to their inability to adhere completely to their oral medications.

Henry A. Nasrallah, MD
Editor-In-Chief

Continue to: LAIs as the standard of care

 

 

LAIs as the standard of care

Thank you, Dr. Nasrallah, for reiterating the importance of compliance with pharmacologic management of schizophrenia after FEP (From the Editor, Current Psychiatry, May 2021, p. 9-12). Long before LAIs, I appreciated the successes patients with schizophrenia experienced when they complied with treatment after the first episode. It was clear that success was forthcoming for patients who had an interested psychiatrist and a committed relationship with them.

As you point out in your editorial, the facts are powerful, well-known, undisputed, and yet not adopted in the United States, when in other countries LAIs are first-line care. Yes, LAIs are expensive, but not nearly as expensive as the disabilities caused by noncompliance are to society.

Why isn’t LAI use the standard of care here in the United States? In the United States, there is advocacy for treatment because there’s money in it. There is no good advocacy for preventive care because there’s no immediate money in it. We have another good example of this in the United States: private, for-profit prisons. They have a vested interest in keeping prisons full and building new ones. Patients with FEP are most often treated in the hospital, where a standard of care could easily be established that mandates LAIs as first-tier care. Why is that not so? Who is pushing for it? Who is resisting?

Your editorial inspired me to advocate more strongly. Do you have advice about how to effect policy change? I know administrators respond when we talk dollars and cents, not quality of care. What is the dollar cost of not using LAIs as the standard of care after FEP? Who cares? Who would listen to the numbers?

Edward A. Major, MD, LFAPA
Clinical Professor of Psychiatry
Upstate Medical Center
Syracuse, New York

Dr. Nasrallah responds

Dr. Major, thanks for your message. Establishing a standard of care for the use of LAIs (or any other therapy) is not that simple. It requires well-coordinated collaboration among several stakeholders (clinicians, researchers, payors, advocacy groups, and a national organization such as the American Psychiatric Association). The cost issue is certainly powerful, but the equation works in favor of LAIs because 1 psychiatric hospitalization due to a psychotic relapse costs up to 3 times the annual cost of an LAI medication that can prevent that rehospitalization. In addition, disability comprises the lion’s share of the large indirect costs of schizophrenia (disability payments, lifetime room and board, incarceration and legal costs, and loss of work and generation of taxes). LAIs can save both lives and expenditures, and a lot of suffering by patients and their families. I, too, long to see the emergence of a rational standard of care for schizophrenia using LAIs right after the initial psychotic episode. Oncology and cardiology have standards of care, so why not psychiatry?

Henry A. Nasrallah, MD
Editor-In-Chief

Continue to: Psychosis and epilepsy

 

 

Psychosis and epilepsy

I just read your editorial regarding the devastating consequences of psychotic relapses (From the Editor, Current Psychiatry, May 2021, p. 9-12). I was shocked to read of the extent of the damage caused by such relapses and the positive impact of LAIs, and I thank you for opening my eyes. 

I work in the spheres of psychiatry, epileptology, and whole genome sequencing, and have experienced a psychotic episode myself (in 2013, after temporal lobe resection and overdose). I now consider myself even more lucky to be out the other side! As Governor for South London and Maudsley NHS Foundation Trust (SLaM) and Trustee for Epilepsy Action, many of our patients have psychosis. Some patients with epilepsy even experience postictal psychosis. Just yesterday, we had a call at SLaM regarding patients from a secure unit, and a psychiatric nurse spoke about patients at risk to themselves and others because of their psychotic illness, and how crucial effective long-term care was.

Torie Robinson
CEO, Epilepsy Sparks

 

Dr. Nasrallah responds

Ms. Robinson, thank you for sharing your story. It is important to note that the neuro­biology of the psychosis that may occur with epilepsy may not be as neurodegenerative as the psychosis of schizophrenia. Many neurologic conditions can be associated with psychotic episodes, not only epilepsy. I am glad you overcame your post-temporal lobectomy psychotic episode and have had a very good outcome with high functioning.

Henry A. Nasrallah, MD
Editor-In-Chief

Disclosures
Dr. Chepke is a consultant to and speaker for Janssen Pharmaceuticals, Otsuka Pharmaceuticals, and Alkermes. The other authors report no financial relationships with any companies whose products are mentioned in their letters, or with manufacturers of competing products.

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Treating psychosis in pregnant women: A measured approach

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The peak age of onset of schizophrenia coincides with the peak childbearing age of 25 to 35 years.1 So it would not be unusual for your patient with schizophrenia to tell you she is trying to get pregnant, or thinks she might be pregnant. In these situations, you must carefully weigh the risks to the mother (eg, relapse, complications) and to the fetus (eg, possible miscarriage, teratogenesis) when deciding whether to continue or change her treatment regimen. When faced with making these decisions, keep the following factors in mind.

1. Most importantly: Do not make knee-jerk changes. Do not suddenly stop medications. Proceed in a thoughtful and measured way.

2. Discuss the risks with your patient. There is no such thing as a risk-free decision. There are potential risks from untreated psychosis as well as from medications. Mothers with untreated psychosis have an increased risk of suicide and violence, as well as poor self-care. Schizophrenia may be associated with an increased risk of poor birth outcomes, including preterm delivery, low birthweight, and neonatal complications.2 Avoid making absolute statements about specific medications during pregnancy; there needs to be an individualized risk-benefit discussion for each patient, and for each medication.

3. Involve the patient’s partner and family in treatment planning if possible. The patient’s family can be important in promoting mental health during pregnancy and the postpartum. Educating the family as well as the patient regarding medications and the risks of untreated mental illness can go a long way toward compliance.

4. Do not rely on what pregnancy category a medication was. There are multiple dimensions to evaluate when considering the use of an antipsychotic agent during pregnancy. Does it increase the risk of miscarriage? Malformations? Preterm birth? Perinatal toxicity? Behavioral teratogenesis (neurodevelopmental sequelae)? Looking for a simple summary or single letter grade minimizes the understanding of the specific outcome of concern in the specific mother. Instead, look at the Pregnancy section under Use in Specific Populations on the medication’s package insert (prescribing information), consult a web site such as MotherToBaby (mothertobaby.org/healthcare-professionals/), and/or search for the latest research on PubMed.

5. Collaborate with the patient’s obstetrician or family medicine physician. Make sure that you are on the same page regarding treating the patient’s psychosis. Other clinicians often will agree with your treatment plan because they understand the risks of untreated psychosis compared with other risks the patient is facing. However, if you don’t communicate with your patient’s other health care professionals, she might receive mixed messages.

6. As for medication choice, pregnancy is the most important time to conduct a careful medication history to inform your choice of medication. Was Medication X ineffective, or did the patient not pick it up from the pharmacy? Did she really have a trial of 3 months, or did she only take it for a week before she decided to stop?

Continue to: Determine which medication has worked for the patient in the past

 

 

7. Determine which medication has worked for the patient in the past. If Medication Y worked before she was pregnant, it is likely to still work during pregnancy. If it is a relatively safe option, it may be the best choice.

8. Avoid multiple medication exposures wherever possible. If a patient is taking Medication Z, it is working, and she tells you she is 3 months pregnant, it is often better to continue it (assuming it is a relatively safe medication) than to switch to Medication A, which has slightly better “safety data.” By switching to a different antipsychotic, you would be exposing the fetus to a second agent that may not even work for the mother.

9. Focus on treating the patient’s present symptoms. Medication doses may need to change due to pregnancy-related changes in symptoms, drug distribution, and/or metabolism.

10. Remain vigilant for other risks. Keep in mind that pregnant women with psychosis often face risks other than psychiatric medications and psychosis. Comorbidities such as substance use disorders, obesity, and poor prenatal care must also be addressed.3

11. Follow your patient more closely during pregnancy. Pregnancy is an uncertain time for any new mother. Be sure to have an open line of communication with the patient, and be responsive to her concerns.

Continue to: Provide psychoeducation about the postpartum period

 

 

12. Provide psychoeducation about the postpartum period. Pregnancy is the time to educate your patient about the importance of sleep, warning signs of exacerbation of psychosis, and breastfeeding safety.

13. Be proactive with future female pa­tients of childbearing age, regardless of whether they tell you they are sexually active. Women with psychosis have higher rates of unplanned pregnancy.3,4 When initiating treatment of psychosis in a woman of childbearing age, rather than treating her with the newest available medication that does not yet have safety data in pregnancy, it is best to start with a medication already known to be relatively safe in pregnancy. This way, if she were to become pregnant, your treatment plan would already be safe and appropriate.

14. Consult a reproductive psychiatrist if needed.

References

1. Einarson A, Boskovic R. Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract. 2009;15(3):183-192.
2. Galbally M, Crabb C. Schizophrenia and psychotic disorders. O&G. 2018;20(3). https://www.ogmagazine.org.au/20/3-20/schizophrenia-and-psychotic-disorders/
3. Miller LJ. Sexuality, reproduction, and family planning in women with schizophrenia. Schizophr Bull. 1997;23(4):623-635.
4. Friedman SH, Hall RCW, Sorrentino RM. Involuntary treatment of psychosis in pregnancy. J Am Acad Psychiatry Law. 2018;46(2):217-223.

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Dr. Hatters Friedman is the Phillip Resnick Professor of Psychiatry, Professor of Reproductive Biology and Pediatrics, Case Western Reserve University, Cleveland, Ohio. Dr. Reed is Senior Clinical Instructor of Psychiatry, Case Western Reserve University, Cleveland, Ohio.

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Dr. Hatters Friedman is the Phillip Resnick Professor of Psychiatry, Professor of Reproductive Biology and Pediatrics, Case Western Reserve University, Cleveland, Ohio. Dr. Reed is Senior Clinical Instructor of Psychiatry, Case Western Reserve University, Cleveland, Ohio.

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The authors report no financial relationships with any companies whose products are mentioned in the article, or with manufacturers of competing products.

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The peak age of onset of schizophrenia coincides with the peak childbearing age of 25 to 35 years.1 So it would not be unusual for your patient with schizophrenia to tell you she is trying to get pregnant, or thinks she might be pregnant. In these situations, you must carefully weigh the risks to the mother (eg, relapse, complications) and to the fetus (eg, possible miscarriage, teratogenesis) when deciding whether to continue or change her treatment regimen. When faced with making these decisions, keep the following factors in mind.

1. Most importantly: Do not make knee-jerk changes. Do not suddenly stop medications. Proceed in a thoughtful and measured way.

2. Discuss the risks with your patient. There is no such thing as a risk-free decision. There are potential risks from untreated psychosis as well as from medications. Mothers with untreated psychosis have an increased risk of suicide and violence, as well as poor self-care. Schizophrenia may be associated with an increased risk of poor birth outcomes, including preterm delivery, low birthweight, and neonatal complications.2 Avoid making absolute statements about specific medications during pregnancy; there needs to be an individualized risk-benefit discussion for each patient, and for each medication.

3. Involve the patient’s partner and family in treatment planning if possible. The patient’s family can be important in promoting mental health during pregnancy and the postpartum. Educating the family as well as the patient regarding medications and the risks of untreated mental illness can go a long way toward compliance.

4. Do not rely on what pregnancy category a medication was. There are multiple dimensions to evaluate when considering the use of an antipsychotic agent during pregnancy. Does it increase the risk of miscarriage? Malformations? Preterm birth? Perinatal toxicity? Behavioral teratogenesis (neurodevelopmental sequelae)? Looking for a simple summary or single letter grade minimizes the understanding of the specific outcome of concern in the specific mother. Instead, look at the Pregnancy section under Use in Specific Populations on the medication’s package insert (prescribing information), consult a web site such as MotherToBaby (mothertobaby.org/healthcare-professionals/), and/or search for the latest research on PubMed.

5. Collaborate with the patient’s obstetrician or family medicine physician. Make sure that you are on the same page regarding treating the patient’s psychosis. Other clinicians often will agree with your treatment plan because they understand the risks of untreated psychosis compared with other risks the patient is facing. However, if you don’t communicate with your patient’s other health care professionals, she might receive mixed messages.

6. As for medication choice, pregnancy is the most important time to conduct a careful medication history to inform your choice of medication. Was Medication X ineffective, or did the patient not pick it up from the pharmacy? Did she really have a trial of 3 months, or did she only take it for a week before she decided to stop?

Continue to: Determine which medication has worked for the patient in the past

 

 

7. Determine which medication has worked for the patient in the past. If Medication Y worked before she was pregnant, it is likely to still work during pregnancy. If it is a relatively safe option, it may be the best choice.

8. Avoid multiple medication exposures wherever possible. If a patient is taking Medication Z, it is working, and she tells you she is 3 months pregnant, it is often better to continue it (assuming it is a relatively safe medication) than to switch to Medication A, which has slightly better “safety data.” By switching to a different antipsychotic, you would be exposing the fetus to a second agent that may not even work for the mother.

9. Focus on treating the patient’s present symptoms. Medication doses may need to change due to pregnancy-related changes in symptoms, drug distribution, and/or metabolism.

10. Remain vigilant for other risks. Keep in mind that pregnant women with psychosis often face risks other than psychiatric medications and psychosis. Comorbidities such as substance use disorders, obesity, and poor prenatal care must also be addressed.3

11. Follow your patient more closely during pregnancy. Pregnancy is an uncertain time for any new mother. Be sure to have an open line of communication with the patient, and be responsive to her concerns.

Continue to: Provide psychoeducation about the postpartum period

 

 

12. Provide psychoeducation about the postpartum period. Pregnancy is the time to educate your patient about the importance of sleep, warning signs of exacerbation of psychosis, and breastfeeding safety.

13. Be proactive with future female pa­tients of childbearing age, regardless of whether they tell you they are sexually active. Women with psychosis have higher rates of unplanned pregnancy.3,4 When initiating treatment of psychosis in a woman of childbearing age, rather than treating her with the newest available medication that does not yet have safety data in pregnancy, it is best to start with a medication already known to be relatively safe in pregnancy. This way, if she were to become pregnant, your treatment plan would already be safe and appropriate.

14. Consult a reproductive psychiatrist if needed.

The peak age of onset of schizophrenia coincides with the peak childbearing age of 25 to 35 years.1 So it would not be unusual for your patient with schizophrenia to tell you she is trying to get pregnant, or thinks she might be pregnant. In these situations, you must carefully weigh the risks to the mother (eg, relapse, complications) and to the fetus (eg, possible miscarriage, teratogenesis) when deciding whether to continue or change her treatment regimen. When faced with making these decisions, keep the following factors in mind.

1. Most importantly: Do not make knee-jerk changes. Do not suddenly stop medications. Proceed in a thoughtful and measured way.

2. Discuss the risks with your patient. There is no such thing as a risk-free decision. There are potential risks from untreated psychosis as well as from medications. Mothers with untreated psychosis have an increased risk of suicide and violence, as well as poor self-care. Schizophrenia may be associated with an increased risk of poor birth outcomes, including preterm delivery, low birthweight, and neonatal complications.2 Avoid making absolute statements about specific medications during pregnancy; there needs to be an individualized risk-benefit discussion for each patient, and for each medication.

3. Involve the patient’s partner and family in treatment planning if possible. The patient’s family can be important in promoting mental health during pregnancy and the postpartum. Educating the family as well as the patient regarding medications and the risks of untreated mental illness can go a long way toward compliance.

4. Do not rely on what pregnancy category a medication was. There are multiple dimensions to evaluate when considering the use of an antipsychotic agent during pregnancy. Does it increase the risk of miscarriage? Malformations? Preterm birth? Perinatal toxicity? Behavioral teratogenesis (neurodevelopmental sequelae)? Looking for a simple summary or single letter grade minimizes the understanding of the specific outcome of concern in the specific mother. Instead, look at the Pregnancy section under Use in Specific Populations on the medication’s package insert (prescribing information), consult a web site such as MotherToBaby (mothertobaby.org/healthcare-professionals/), and/or search for the latest research on PubMed.

5. Collaborate with the patient’s obstetrician or family medicine physician. Make sure that you are on the same page regarding treating the patient’s psychosis. Other clinicians often will agree with your treatment plan because they understand the risks of untreated psychosis compared with other risks the patient is facing. However, if you don’t communicate with your patient’s other health care professionals, she might receive mixed messages.

6. As for medication choice, pregnancy is the most important time to conduct a careful medication history to inform your choice of medication. Was Medication X ineffective, or did the patient not pick it up from the pharmacy? Did she really have a trial of 3 months, or did she only take it for a week before she decided to stop?

Continue to: Determine which medication has worked for the patient in the past

 

 

7. Determine which medication has worked for the patient in the past. If Medication Y worked before she was pregnant, it is likely to still work during pregnancy. If it is a relatively safe option, it may be the best choice.

8. Avoid multiple medication exposures wherever possible. If a patient is taking Medication Z, it is working, and she tells you she is 3 months pregnant, it is often better to continue it (assuming it is a relatively safe medication) than to switch to Medication A, which has slightly better “safety data.” By switching to a different antipsychotic, you would be exposing the fetus to a second agent that may not even work for the mother.

9. Focus on treating the patient’s present symptoms. Medication doses may need to change due to pregnancy-related changes in symptoms, drug distribution, and/or metabolism.

10. Remain vigilant for other risks. Keep in mind that pregnant women with psychosis often face risks other than psychiatric medications and psychosis. Comorbidities such as substance use disorders, obesity, and poor prenatal care must also be addressed.3

11. Follow your patient more closely during pregnancy. Pregnancy is an uncertain time for any new mother. Be sure to have an open line of communication with the patient, and be responsive to her concerns.

Continue to: Provide psychoeducation about the postpartum period

 

 

12. Provide psychoeducation about the postpartum period. Pregnancy is the time to educate your patient about the importance of sleep, warning signs of exacerbation of psychosis, and breastfeeding safety.

13. Be proactive with future female pa­tients of childbearing age, regardless of whether they tell you they are sexually active. Women with psychosis have higher rates of unplanned pregnancy.3,4 When initiating treatment of psychosis in a woman of childbearing age, rather than treating her with the newest available medication that does not yet have safety data in pregnancy, it is best to start with a medication already known to be relatively safe in pregnancy. This way, if she were to become pregnant, your treatment plan would already be safe and appropriate.

14. Consult a reproductive psychiatrist if needed.

References

1. Einarson A, Boskovic R. Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract. 2009;15(3):183-192.
2. Galbally M, Crabb C. Schizophrenia and psychotic disorders. O&G. 2018;20(3). https://www.ogmagazine.org.au/20/3-20/schizophrenia-and-psychotic-disorders/
3. Miller LJ. Sexuality, reproduction, and family planning in women with schizophrenia. Schizophr Bull. 1997;23(4):623-635.
4. Friedman SH, Hall RCW, Sorrentino RM. Involuntary treatment of psychosis in pregnancy. J Am Acad Psychiatry Law. 2018;46(2):217-223.

References

1. Einarson A, Boskovic R. Use and safety of antipsychotic drugs during pregnancy. J Psychiatr Pract. 2009;15(3):183-192.
2. Galbally M, Crabb C. Schizophrenia and psychotic disorders. O&G. 2018;20(3). https://www.ogmagazine.org.au/20/3-20/schizophrenia-and-psychotic-disorders/
3. Miller LJ. Sexuality, reproduction, and family planning in women with schizophrenia. Schizophr Bull. 1997;23(4):623-635.
4. Friedman SH, Hall RCW, Sorrentino RM. Involuntary treatment of psychosis in pregnancy. J Am Acad Psychiatry Law. 2018;46(2):217-223.

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Long-acting injectable antipsychotics deserve first-line consideration

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Long-acting injectable (LAI) antipsychotic therapies continue to be largely reserved for patients who already have adherence issues. But most patients, including first-episode patients, should be considering drugs with this mode of delivery for their broad array of advantages, according to an overview presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Dr. Diana Perkins

“Due to the perception that long-acting injectables are for coercive applications, patients are not hearing about the many reasons this option might be preferable,” reported Diana Perkins, MD, MPH, professor, department of psychiatry, University of North Carolina, Chapel Hill.

According to Dr. Perkins, patients starting treatment for first-episode schizophrenia are particularly unlikely to even hear about injectable therapies even though “these might be the best candidates.”

The advantage of LAI in first-episode patients is that it takes adherence off the table as a risk for treatment failure. Ultimately, many patients educated about LAI in the context of other options, prefer LAI, according to Dr. Perkins, and she provided data to support these assertions.

Of several published articles reporting that patients fail to discuss LAI with patients, one was published last year (J Clin Psychopharmacol. 2020 Jul/Aug;40:346-9). For evidence that patients prefer LAI over pills for antipsychotic treatment, Dr. Perkins cited a study with data from more than 1,400 patients (Patient Prefer Adherence. 2020;14:1093-102).

In this latter analysis, 77% of patients preferred LAI over pills, Dr. Perkins reported at the virtual meeting, presented by MedscapeLive. Moreover, 50% of patients preferred every-3-month injections over monthly injections. For those who preferred LAI, the reasons included the convenience of avoiding daily therapy but also the empowerment derived from feeling healthier from not having to depend on a daily schedule of treatment.
 

LAI has benefits independent of adherence

“Some patients prefer injectables because the daily pills remind them of their illness even when they are feeling well,” Dr. Perkins said.

By eliminating pills and pill bottles, injections also provide a certain degree of confidentiality, said Dr. Perkins. She said that LAI, which avoids the peaks and troughs inherent in pill taking, provides more consistent drug levels even to the degree that doses can sometimes be lowered and adverse events reduced.

Yet, of all the reasons that patients might want to consider LAI, the most compelling is a lower risk of failure from inadequate adherence to daily pills. The evidence that patients do not take daily pills for chronic diseases, whether schizophrenia or any other illness that requires maintenance regimens for persistent disease control, is extensive and overwhelming, according to Dr. Perkins, who cited multiple studies.

For schizophrenia, with a relapsing and remitting pattern of symptoms, poor adherence is a particular risk. When symptoms abate, the cue and motivation for adherence dissipates.

“Most patients with schizophrenia already have some ambivalence about taking their medication. Symptoms are a powerful reminder, but people just forget when the treatment is for prevention,” Dr. Perkins said.

When patients forget their daily pills or when the they decide to skip doses when they feel well, they do not necessarily tell their physicians.
 

 

 

Poor adherence often goes unrecognized

“Clinicians are not very good at estimating adherence in their patients,” Dr. Perkins said. While she listed several strategies to help patients adhere to daily pills, she also said that LAI should not be discounted as a means to circumvent this problem altogether.

Importantly, suboptimal adherence by itself places the patient at a high risk for relapse. In one study of partial adherence, delayed doses were associated with increased risk of hospitalization overall, but each increment in further delay led to still more risk (Psychiatr Serv. 2004;55:886-91).

Imperfect adherence to daily pills is very common. In one study evaluating 34,000 veterans with schizophrenia, the proportion with consistently good adherence over the 12 months of study was not quite 40% (J Clin Psychiatry. 2006 Oct;67[10]:1542-50). While most of the remaining were intermittently adherent, more than 15% of the populations was consistently poorly adherent.
 

Simple regimens and adherence closely linked

In general, the simpler the regimen, the greater the adherence, according to Dr. Perkins. For oral therapies, one pill per day is associated with greater adherence than is more than one. LAI, which is even simpler, is consistently associated with a large relative advantage. In one comparative study, 77% were adherent to LAI versus about 30% (P < .001) over a period of 12 months (Ment Health Clin. 2018 Mar 26;8[2]:56-62).

In a large recently published meta-analysis, LAI was associated with objective advantages over oral therapy (Lancet Psychiatry. 2021 May 1;8:[5]387-404). This included a statistically significant lower risk of hospitalizations or relapses for LAI over oral therapy whether the two modes of delivery were compared in randomized controls studies (RR 0.88; P = .033) or cohort studies (RR 0.92; P = .0044).

Overall, clinicians should discard several false assumptions about LAI, including the fact they are not appropriate in first-episode disease and that patients will not elect to take LAI if informed of the choices, according to Dr. Perkins. Rather than just listing LAI among options, Dr. Perkins suggested that clinicians should specifically explain the many advantages.

“When people say I do not like shots, this is not necessarily a no,” she said. If patients understand the potential for a reduced risk of relapse without having to take a daily pill, injections might be preferable whether or not they like shots in particular.

This is not an isolated view among experienced physicians. John M. Kane, MD, chairman of psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y., also sees LAI as method of drug delivery that should be considered widely in schizophrenia.

“I am in complete agreement with Dr. Perkins that long-acting injectable formulations of antipsychotic medications should be presented routinely to patients and families as an option for illness management and relapse prevention,” said Dr. Kane, who was a coauthor of the meta-analysis published in Lancet Psychiatry.

“This would include patients early in the course of illness who currently have an unnecessarily high risk of relapse and hospitalization,” he added.

MedscapeLive and this news organization are owned by the same parent company. Dr. Perkins has a financial relationship with Alkermes. Dr. Kane has financial relationships with Abbott, AstraZeneca, Bristol-Myers Squibb, Janssen, Lilly, Otsuka, Pfizer, and Wyeth.

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Long-acting injectable (LAI) antipsychotic therapies continue to be largely reserved for patients who already have adherence issues. But most patients, including first-episode patients, should be considering drugs with this mode of delivery for their broad array of advantages, according to an overview presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Dr. Diana Perkins

“Due to the perception that long-acting injectables are for coercive applications, patients are not hearing about the many reasons this option might be preferable,” reported Diana Perkins, MD, MPH, professor, department of psychiatry, University of North Carolina, Chapel Hill.

According to Dr. Perkins, patients starting treatment for first-episode schizophrenia are particularly unlikely to even hear about injectable therapies even though “these might be the best candidates.”

The advantage of LAI in first-episode patients is that it takes adherence off the table as a risk for treatment failure. Ultimately, many patients educated about LAI in the context of other options, prefer LAI, according to Dr. Perkins, and she provided data to support these assertions.

Of several published articles reporting that patients fail to discuss LAI with patients, one was published last year (J Clin Psychopharmacol. 2020 Jul/Aug;40:346-9). For evidence that patients prefer LAI over pills for antipsychotic treatment, Dr. Perkins cited a study with data from more than 1,400 patients (Patient Prefer Adherence. 2020;14:1093-102).

In this latter analysis, 77% of patients preferred LAI over pills, Dr. Perkins reported at the virtual meeting, presented by MedscapeLive. Moreover, 50% of patients preferred every-3-month injections over monthly injections. For those who preferred LAI, the reasons included the convenience of avoiding daily therapy but also the empowerment derived from feeling healthier from not having to depend on a daily schedule of treatment.
 

LAI has benefits independent of adherence

“Some patients prefer injectables because the daily pills remind them of their illness even when they are feeling well,” Dr. Perkins said.

By eliminating pills and pill bottles, injections also provide a certain degree of confidentiality, said Dr. Perkins. She said that LAI, which avoids the peaks and troughs inherent in pill taking, provides more consistent drug levels even to the degree that doses can sometimes be lowered and adverse events reduced.

Yet, of all the reasons that patients might want to consider LAI, the most compelling is a lower risk of failure from inadequate adherence to daily pills. The evidence that patients do not take daily pills for chronic diseases, whether schizophrenia or any other illness that requires maintenance regimens for persistent disease control, is extensive and overwhelming, according to Dr. Perkins, who cited multiple studies.

For schizophrenia, with a relapsing and remitting pattern of symptoms, poor adherence is a particular risk. When symptoms abate, the cue and motivation for adherence dissipates.

“Most patients with schizophrenia already have some ambivalence about taking their medication. Symptoms are a powerful reminder, but people just forget when the treatment is for prevention,” Dr. Perkins said.

When patients forget their daily pills or when the they decide to skip doses when they feel well, they do not necessarily tell their physicians.
 

 

 

Poor adherence often goes unrecognized

“Clinicians are not very good at estimating adherence in their patients,” Dr. Perkins said. While she listed several strategies to help patients adhere to daily pills, she also said that LAI should not be discounted as a means to circumvent this problem altogether.

Importantly, suboptimal adherence by itself places the patient at a high risk for relapse. In one study of partial adherence, delayed doses were associated with increased risk of hospitalization overall, but each increment in further delay led to still more risk (Psychiatr Serv. 2004;55:886-91).

Imperfect adherence to daily pills is very common. In one study evaluating 34,000 veterans with schizophrenia, the proportion with consistently good adherence over the 12 months of study was not quite 40% (J Clin Psychiatry. 2006 Oct;67[10]:1542-50). While most of the remaining were intermittently adherent, more than 15% of the populations was consistently poorly adherent.
 

Simple regimens and adherence closely linked

In general, the simpler the regimen, the greater the adherence, according to Dr. Perkins. For oral therapies, one pill per day is associated with greater adherence than is more than one. LAI, which is even simpler, is consistently associated with a large relative advantage. In one comparative study, 77% were adherent to LAI versus about 30% (P < .001) over a period of 12 months (Ment Health Clin. 2018 Mar 26;8[2]:56-62).

In a large recently published meta-analysis, LAI was associated with objective advantages over oral therapy (Lancet Psychiatry. 2021 May 1;8:[5]387-404). This included a statistically significant lower risk of hospitalizations or relapses for LAI over oral therapy whether the two modes of delivery were compared in randomized controls studies (RR 0.88; P = .033) or cohort studies (RR 0.92; P = .0044).

Overall, clinicians should discard several false assumptions about LAI, including the fact they are not appropriate in first-episode disease and that patients will not elect to take LAI if informed of the choices, according to Dr. Perkins. Rather than just listing LAI among options, Dr. Perkins suggested that clinicians should specifically explain the many advantages.

“When people say I do not like shots, this is not necessarily a no,” she said. If patients understand the potential for a reduced risk of relapse without having to take a daily pill, injections might be preferable whether or not they like shots in particular.

This is not an isolated view among experienced physicians. John M. Kane, MD, chairman of psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y., also sees LAI as method of drug delivery that should be considered widely in schizophrenia.

“I am in complete agreement with Dr. Perkins that long-acting injectable formulations of antipsychotic medications should be presented routinely to patients and families as an option for illness management and relapse prevention,” said Dr. Kane, who was a coauthor of the meta-analysis published in Lancet Psychiatry.

“This would include patients early in the course of illness who currently have an unnecessarily high risk of relapse and hospitalization,” he added.

MedscapeLive and this news organization are owned by the same parent company. Dr. Perkins has a financial relationship with Alkermes. Dr. Kane has financial relationships with Abbott, AstraZeneca, Bristol-Myers Squibb, Janssen, Lilly, Otsuka, Pfizer, and Wyeth.

Long-acting injectable (LAI) antipsychotic therapies continue to be largely reserved for patients who already have adherence issues. But most patients, including first-episode patients, should be considering drugs with this mode of delivery for their broad array of advantages, according to an overview presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Dr. Diana Perkins

“Due to the perception that long-acting injectables are for coercive applications, patients are not hearing about the many reasons this option might be preferable,” reported Diana Perkins, MD, MPH, professor, department of psychiatry, University of North Carolina, Chapel Hill.

According to Dr. Perkins, patients starting treatment for first-episode schizophrenia are particularly unlikely to even hear about injectable therapies even though “these might be the best candidates.”

The advantage of LAI in first-episode patients is that it takes adherence off the table as a risk for treatment failure. Ultimately, many patients educated about LAI in the context of other options, prefer LAI, according to Dr. Perkins, and she provided data to support these assertions.

Of several published articles reporting that patients fail to discuss LAI with patients, one was published last year (J Clin Psychopharmacol. 2020 Jul/Aug;40:346-9). For evidence that patients prefer LAI over pills for antipsychotic treatment, Dr. Perkins cited a study with data from more than 1,400 patients (Patient Prefer Adherence. 2020;14:1093-102).

In this latter analysis, 77% of patients preferred LAI over pills, Dr. Perkins reported at the virtual meeting, presented by MedscapeLive. Moreover, 50% of patients preferred every-3-month injections over monthly injections. For those who preferred LAI, the reasons included the convenience of avoiding daily therapy but also the empowerment derived from feeling healthier from not having to depend on a daily schedule of treatment.
 

LAI has benefits independent of adherence

“Some patients prefer injectables because the daily pills remind them of their illness even when they are feeling well,” Dr. Perkins said.

By eliminating pills and pill bottles, injections also provide a certain degree of confidentiality, said Dr. Perkins. She said that LAI, which avoids the peaks and troughs inherent in pill taking, provides more consistent drug levels even to the degree that doses can sometimes be lowered and adverse events reduced.

Yet, of all the reasons that patients might want to consider LAI, the most compelling is a lower risk of failure from inadequate adherence to daily pills. The evidence that patients do not take daily pills for chronic diseases, whether schizophrenia or any other illness that requires maintenance regimens for persistent disease control, is extensive and overwhelming, according to Dr. Perkins, who cited multiple studies.

For schizophrenia, with a relapsing and remitting pattern of symptoms, poor adherence is a particular risk. When symptoms abate, the cue and motivation for adherence dissipates.

“Most patients with schizophrenia already have some ambivalence about taking their medication. Symptoms are a powerful reminder, but people just forget when the treatment is for prevention,” Dr. Perkins said.

When patients forget their daily pills or when the they decide to skip doses when they feel well, they do not necessarily tell their physicians.
 

 

 

Poor adherence often goes unrecognized

“Clinicians are not very good at estimating adherence in their patients,” Dr. Perkins said. While she listed several strategies to help patients adhere to daily pills, she also said that LAI should not be discounted as a means to circumvent this problem altogether.

Importantly, suboptimal adherence by itself places the patient at a high risk for relapse. In one study of partial adherence, delayed doses were associated with increased risk of hospitalization overall, but each increment in further delay led to still more risk (Psychiatr Serv. 2004;55:886-91).

Imperfect adherence to daily pills is very common. In one study evaluating 34,000 veterans with schizophrenia, the proportion with consistently good adherence over the 12 months of study was not quite 40% (J Clin Psychiatry. 2006 Oct;67[10]:1542-50). While most of the remaining were intermittently adherent, more than 15% of the populations was consistently poorly adherent.
 

Simple regimens and adherence closely linked

In general, the simpler the regimen, the greater the adherence, according to Dr. Perkins. For oral therapies, one pill per day is associated with greater adherence than is more than one. LAI, which is even simpler, is consistently associated with a large relative advantage. In one comparative study, 77% were adherent to LAI versus about 30% (P < .001) over a period of 12 months (Ment Health Clin. 2018 Mar 26;8[2]:56-62).

In a large recently published meta-analysis, LAI was associated with objective advantages over oral therapy (Lancet Psychiatry. 2021 May 1;8:[5]387-404). This included a statistically significant lower risk of hospitalizations or relapses for LAI over oral therapy whether the two modes of delivery were compared in randomized controls studies (RR 0.88; P = .033) or cohort studies (RR 0.92; P = .0044).

Overall, clinicians should discard several false assumptions about LAI, including the fact they are not appropriate in first-episode disease and that patients will not elect to take LAI if informed of the choices, according to Dr. Perkins. Rather than just listing LAI among options, Dr. Perkins suggested that clinicians should specifically explain the many advantages.

“When people say I do not like shots, this is not necessarily a no,” she said. If patients understand the potential for a reduced risk of relapse without having to take a daily pill, injections might be preferable whether or not they like shots in particular.

This is not an isolated view among experienced physicians. John M. Kane, MD, chairman of psychiatry, Zucker Hillside Hospital, Northwell Health, Glen Oaks, N.Y., also sees LAI as method of drug delivery that should be considered widely in schizophrenia.

“I am in complete agreement with Dr. Perkins that long-acting injectable formulations of antipsychotic medications should be presented routinely to patients and families as an option for illness management and relapse prevention,” said Dr. Kane, who was a coauthor of the meta-analysis published in Lancet Psychiatry.

“This would include patients early in the course of illness who currently have an unnecessarily high risk of relapse and hospitalization,” he added.

MedscapeLive and this news organization are owned by the same parent company. Dr. Perkins has a financial relationship with Alkermes. Dr. Kane has financial relationships with Abbott, AstraZeneca, Bristol-Myers Squibb, Janssen, Lilly, Otsuka, Pfizer, and Wyeth.

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Emerging drugs for schizophrenia targeting negative symptoms

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Late-stage trials of new antipsychotic drugs are showing promise in the control of negative symptoms, according to an overview presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Dr. Henry A. Nasrallah

The progress in these trials deserves attention, because control of negative symptoms is “a major unmet need in schizophrenia,” according to Henry A. Nasrallah, MD, director of the schizophrenia program at the University of Cincinnati.

The novel mechanisms of the agents in development are credited with the promise. Not least, several antipsychotic agents with activity against both positive and negative symptoms “are completely devoid of dopamine receptor blockade,” Dr. Nasrallah said at the virtual meeting, presented by MedscapeLive!

The xanomeline portion of the investigational treatment xanomeline-trospium is one example. Xanomeline is a muscarinic receptor agonist with no activity on dopamine D2 receptors. The role of trospium, a muscarinic receptor antagonist, is to reduce peripheral cholinergic side effects.
 

Xanomeline-trospium: Negative vs. positive symptoms

In a recently published placebo-controlled, double-blind, phase 2 trial, the reductions relative to placebo after 5 weeks on the negative subscale of the Positive and Negative Syndrome Scale (PANSS) tool (–3.9 vs. –1.3; P < .001) was about as robust as that achieved on the positive subscale (–5.6 vs. –3.2; P < .001).

These subscales were secondary endpoints. Relative to placebo, xanomeline-trospium was also effective on the primary endpoint of the PANSS total score (–17.9 vs. –5.9; P < .001).

The presence of trospium did not eliminate cholinergic side effects, which included constipation, dry mouth, and nausea, but the therapy strengthens the evidence that newer agents with novel mechanisms of action, including those without dopamine blockade, can achieve meaningful clinical effects.



SEP-363856, another example of an experimental agent without direct dopamine blockade, was also recently tested in placebo-controlled, double-blind study.

“This is the first agonist of the TAAR1 [trace amine-associated receptor 1] and 5-HT1A [serotonin 5–hydroxytryptamine type 1A receptor] to reach clinical trials,” said Dr. Nasrallah, calling this an interesting agent for its range of clinical activity, which appears to include antianxiety effects.

SEP-363856: Negative vs. positive symptoms

It also appears to include activity against negative symptoms. While the primary endpoint of total PANSS score favored SEP-363856 over placebo at the end of 4 weeks (–17.2 points vs. –9.7; P = .001), the reductions in the subscales for negative (–3.1 vs. –1.6) and positive (–5.5 vs. 3.9) symptoms were also substantial even if statistical differences were not calculated.

The rates of side effects on SEP-3638656 were low, according to Dr. Nasrallah. The most common complaints, such as somnolence, agitation, and nausea, were observed in fewer than 10% of patients.

Roluperidone, another agent with no direct dopamine blockade, has reached phase 3 trials. The activity of this agent is attributed to antagonist activity on the serotonin 5-HT2A and sigma2 receptors. In a multinational, phase 2b study cited by Dr. Nasrallah, both of two study doses of roluperidone were superior to placebo for the negative symptom dimensions of expressive deficit and experiential deficit. Patients enrolled in the trial were required to have baseline PANSS negative symptom subscale scores of 20 points or greater.

Pimavanserin, an inverse agonist of 5-HT2A receptors, is already approved for the treatment of psychosis in Parkinson’s disease, but it is now attracting interest for its potential efficacy against negative symptoms in schizophrenia, according to Dr. Nasrallah, who cited a poster presented last November at the Psych Congress 2020.

The poster provided results of ADVANCE, a double-blind, placebo-controlled, phase 2 study that associated pimavanserin with significant improvement across several types of negative symptoms, Dr. Nasrallah said. The drug was well tolerated with a side-effect profile “similar to placebo.”

Traditional antipsychotic therapies are generally associated with limited effect against negative symptoms, but it has never been proven that the interaction of treatments on the dopaminergic system is the reason. Indeed, in his list of therapies being pursued for potential benefit against negative symptoms, Dr. Nasrallah cited a clinical study with cariprazine, an agent with multiple effects on dopamine and serotonin signaling.



“Cariprazine is a partial agonist at D2, D3, and 5-HT1A receptors and an antagonist at 5-HT2c and 5-HT7 receptors, but it has the highest affinity to the D3 receptor,” Dr. Nasrallah reported.

Cariprazine is already approved for schizophrenia, acute mania, and bipolar depression, but the authors of a recent review claim evidence of activity against negative symptoms. Furthermore, they speculate that this activity might be mediated by agonism of the D3 receptor.

Despite the evidence that these agents might control negative symptoms, the relative roles will be defined by clinical experience, not just clinical trials, Dr. Nasrallah said. However, he did indicate that there appears to be meaningful progress in this area.

Potential progress in this area is important, because “negative symptoms are a largely unaddressed treatment target in people with schizophrenia,” reported Christoph U. Correll, MD, professor of psychiatry, Hofstra University, Hempstead, N.Y. These symptoms deserve attention for their “important potential to improve interpersonal, educational, and work function.”

Dr. Correll agreed that the newer drugs with mechanisms other than postsynaptic dopamine blockade could be a very important advance in the treatment of schizophrenia.

“Promising new medications with potential efficacy for negative symptoms, either based on their pharmacological profile and/or emerging data, include cariprazine, lumateperone, ulotaront [SEP-363856], and xanomeline plus trospium,” he said. Efficacy for negative symptoms, if proven, will address an “elusive goal.”

MedscapeLive! and this news organization are owned by the same parent company. Dr. Nasrallah reported financial relationships with Acadia Pharmaceuticals, Alkermes, Avanir, Intra-Cellular Therapies, Indivior, Janssen, Neurocrine, and Teva. Dr. Correll listed financial relationships with more than 25 pharmaceutical companies, including several developing medications with potential activity against negative symptoms.

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Late-stage trials of new antipsychotic drugs are showing promise in the control of negative symptoms, according to an overview presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Dr. Henry A. Nasrallah

The progress in these trials deserves attention, because control of negative symptoms is “a major unmet need in schizophrenia,” according to Henry A. Nasrallah, MD, director of the schizophrenia program at the University of Cincinnati.

The novel mechanisms of the agents in development are credited with the promise. Not least, several antipsychotic agents with activity against both positive and negative symptoms “are completely devoid of dopamine receptor blockade,” Dr. Nasrallah said at the virtual meeting, presented by MedscapeLive!

The xanomeline portion of the investigational treatment xanomeline-trospium is one example. Xanomeline is a muscarinic receptor agonist with no activity on dopamine D2 receptors. The role of trospium, a muscarinic receptor antagonist, is to reduce peripheral cholinergic side effects.
 

Xanomeline-trospium: Negative vs. positive symptoms

In a recently published placebo-controlled, double-blind, phase 2 trial, the reductions relative to placebo after 5 weeks on the negative subscale of the Positive and Negative Syndrome Scale (PANSS) tool (–3.9 vs. –1.3; P < .001) was about as robust as that achieved on the positive subscale (–5.6 vs. –3.2; P < .001).

These subscales were secondary endpoints. Relative to placebo, xanomeline-trospium was also effective on the primary endpoint of the PANSS total score (–17.9 vs. –5.9; P < .001).

The presence of trospium did not eliminate cholinergic side effects, which included constipation, dry mouth, and nausea, but the therapy strengthens the evidence that newer agents with novel mechanisms of action, including those without dopamine blockade, can achieve meaningful clinical effects.



SEP-363856, another example of an experimental agent without direct dopamine blockade, was also recently tested in placebo-controlled, double-blind study.

“This is the first agonist of the TAAR1 [trace amine-associated receptor 1] and 5-HT1A [serotonin 5–hydroxytryptamine type 1A receptor] to reach clinical trials,” said Dr. Nasrallah, calling this an interesting agent for its range of clinical activity, which appears to include antianxiety effects.

SEP-363856: Negative vs. positive symptoms

It also appears to include activity against negative symptoms. While the primary endpoint of total PANSS score favored SEP-363856 over placebo at the end of 4 weeks (–17.2 points vs. –9.7; P = .001), the reductions in the subscales for negative (–3.1 vs. –1.6) and positive (–5.5 vs. 3.9) symptoms were also substantial even if statistical differences were not calculated.

The rates of side effects on SEP-3638656 were low, according to Dr. Nasrallah. The most common complaints, such as somnolence, agitation, and nausea, were observed in fewer than 10% of patients.

Roluperidone, another agent with no direct dopamine blockade, has reached phase 3 trials. The activity of this agent is attributed to antagonist activity on the serotonin 5-HT2A and sigma2 receptors. In a multinational, phase 2b study cited by Dr. Nasrallah, both of two study doses of roluperidone were superior to placebo for the negative symptom dimensions of expressive deficit and experiential deficit. Patients enrolled in the trial were required to have baseline PANSS negative symptom subscale scores of 20 points or greater.

Pimavanserin, an inverse agonist of 5-HT2A receptors, is already approved for the treatment of psychosis in Parkinson’s disease, but it is now attracting interest for its potential efficacy against negative symptoms in schizophrenia, according to Dr. Nasrallah, who cited a poster presented last November at the Psych Congress 2020.

The poster provided results of ADVANCE, a double-blind, placebo-controlled, phase 2 study that associated pimavanserin with significant improvement across several types of negative symptoms, Dr. Nasrallah said. The drug was well tolerated with a side-effect profile “similar to placebo.”

Traditional antipsychotic therapies are generally associated with limited effect against negative symptoms, but it has never been proven that the interaction of treatments on the dopaminergic system is the reason. Indeed, in his list of therapies being pursued for potential benefit against negative symptoms, Dr. Nasrallah cited a clinical study with cariprazine, an agent with multiple effects on dopamine and serotonin signaling.



“Cariprazine is a partial agonist at D2, D3, and 5-HT1A receptors and an antagonist at 5-HT2c and 5-HT7 receptors, but it has the highest affinity to the D3 receptor,” Dr. Nasrallah reported.

Cariprazine is already approved for schizophrenia, acute mania, and bipolar depression, but the authors of a recent review claim evidence of activity against negative symptoms. Furthermore, they speculate that this activity might be mediated by agonism of the D3 receptor.

Despite the evidence that these agents might control negative symptoms, the relative roles will be defined by clinical experience, not just clinical trials, Dr. Nasrallah said. However, he did indicate that there appears to be meaningful progress in this area.

Potential progress in this area is important, because “negative symptoms are a largely unaddressed treatment target in people with schizophrenia,” reported Christoph U. Correll, MD, professor of psychiatry, Hofstra University, Hempstead, N.Y. These symptoms deserve attention for their “important potential to improve interpersonal, educational, and work function.”

Dr. Correll agreed that the newer drugs with mechanisms other than postsynaptic dopamine blockade could be a very important advance in the treatment of schizophrenia.

“Promising new medications with potential efficacy for negative symptoms, either based on their pharmacological profile and/or emerging data, include cariprazine, lumateperone, ulotaront [SEP-363856], and xanomeline plus trospium,” he said. Efficacy for negative symptoms, if proven, will address an “elusive goal.”

MedscapeLive! and this news organization are owned by the same parent company. Dr. Nasrallah reported financial relationships with Acadia Pharmaceuticals, Alkermes, Avanir, Intra-Cellular Therapies, Indivior, Janssen, Neurocrine, and Teva. Dr. Correll listed financial relationships with more than 25 pharmaceutical companies, including several developing medications with potential activity against negative symptoms.

Late-stage trials of new antipsychotic drugs are showing promise in the control of negative symptoms, according to an overview presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.

Dr. Henry A. Nasrallah

The progress in these trials deserves attention, because control of negative symptoms is “a major unmet need in schizophrenia,” according to Henry A. Nasrallah, MD, director of the schizophrenia program at the University of Cincinnati.

The novel mechanisms of the agents in development are credited with the promise. Not least, several antipsychotic agents with activity against both positive and negative symptoms “are completely devoid of dopamine receptor blockade,” Dr. Nasrallah said at the virtual meeting, presented by MedscapeLive!

The xanomeline portion of the investigational treatment xanomeline-trospium is one example. Xanomeline is a muscarinic receptor agonist with no activity on dopamine D2 receptors. The role of trospium, a muscarinic receptor antagonist, is to reduce peripheral cholinergic side effects.
 

Xanomeline-trospium: Negative vs. positive symptoms

In a recently published placebo-controlled, double-blind, phase 2 trial, the reductions relative to placebo after 5 weeks on the negative subscale of the Positive and Negative Syndrome Scale (PANSS) tool (–3.9 vs. –1.3; P < .001) was about as robust as that achieved on the positive subscale (–5.6 vs. –3.2; P < .001).

These subscales were secondary endpoints. Relative to placebo, xanomeline-trospium was also effective on the primary endpoint of the PANSS total score (–17.9 vs. –5.9; P < .001).

The presence of trospium did not eliminate cholinergic side effects, which included constipation, dry mouth, and nausea, but the therapy strengthens the evidence that newer agents with novel mechanisms of action, including those without dopamine blockade, can achieve meaningful clinical effects.



SEP-363856, another example of an experimental agent without direct dopamine blockade, was also recently tested in placebo-controlled, double-blind study.

“This is the first agonist of the TAAR1 [trace amine-associated receptor 1] and 5-HT1A [serotonin 5–hydroxytryptamine type 1A receptor] to reach clinical trials,” said Dr. Nasrallah, calling this an interesting agent for its range of clinical activity, which appears to include antianxiety effects.

SEP-363856: Negative vs. positive symptoms

It also appears to include activity against negative symptoms. While the primary endpoint of total PANSS score favored SEP-363856 over placebo at the end of 4 weeks (–17.2 points vs. –9.7; P = .001), the reductions in the subscales for negative (–3.1 vs. –1.6) and positive (–5.5 vs. 3.9) symptoms were also substantial even if statistical differences were not calculated.

The rates of side effects on SEP-3638656 were low, according to Dr. Nasrallah. The most common complaints, such as somnolence, agitation, and nausea, were observed in fewer than 10% of patients.

Roluperidone, another agent with no direct dopamine blockade, has reached phase 3 trials. The activity of this agent is attributed to antagonist activity on the serotonin 5-HT2A and sigma2 receptors. In a multinational, phase 2b study cited by Dr. Nasrallah, both of two study doses of roluperidone were superior to placebo for the negative symptom dimensions of expressive deficit and experiential deficit. Patients enrolled in the trial were required to have baseline PANSS negative symptom subscale scores of 20 points or greater.

Pimavanserin, an inverse agonist of 5-HT2A receptors, is already approved for the treatment of psychosis in Parkinson’s disease, but it is now attracting interest for its potential efficacy against negative symptoms in schizophrenia, according to Dr. Nasrallah, who cited a poster presented last November at the Psych Congress 2020.

The poster provided results of ADVANCE, a double-blind, placebo-controlled, phase 2 study that associated pimavanserin with significant improvement across several types of negative symptoms, Dr. Nasrallah said. The drug was well tolerated with a side-effect profile “similar to placebo.”

Traditional antipsychotic therapies are generally associated with limited effect against negative symptoms, but it has never been proven that the interaction of treatments on the dopaminergic system is the reason. Indeed, in his list of therapies being pursued for potential benefit against negative symptoms, Dr. Nasrallah cited a clinical study with cariprazine, an agent with multiple effects on dopamine and serotonin signaling.



“Cariprazine is a partial agonist at D2, D3, and 5-HT1A receptors and an antagonist at 5-HT2c and 5-HT7 receptors, but it has the highest affinity to the D3 receptor,” Dr. Nasrallah reported.

Cariprazine is already approved for schizophrenia, acute mania, and bipolar depression, but the authors of a recent review claim evidence of activity against negative symptoms. Furthermore, they speculate that this activity might be mediated by agonism of the D3 receptor.

Despite the evidence that these agents might control negative symptoms, the relative roles will be defined by clinical experience, not just clinical trials, Dr. Nasrallah said. However, he did indicate that there appears to be meaningful progress in this area.

Potential progress in this area is important, because “negative symptoms are a largely unaddressed treatment target in people with schizophrenia,” reported Christoph U. Correll, MD, professor of psychiatry, Hofstra University, Hempstead, N.Y. These symptoms deserve attention for their “important potential to improve interpersonal, educational, and work function.”

Dr. Correll agreed that the newer drugs with mechanisms other than postsynaptic dopamine blockade could be a very important advance in the treatment of schizophrenia.

“Promising new medications with potential efficacy for negative symptoms, either based on their pharmacological profile and/or emerging data, include cariprazine, lumateperone, ulotaront [SEP-363856], and xanomeline plus trospium,” he said. Efficacy for negative symptoms, if proven, will address an “elusive goal.”

MedscapeLive! and this news organization are owned by the same parent company. Dr. Nasrallah reported financial relationships with Acadia Pharmaceuticals, Alkermes, Avanir, Intra-Cellular Therapies, Indivior, Janssen, Neurocrine, and Teva. Dr. Correll listed financial relationships with more than 25 pharmaceutical companies, including several developing medications with potential activity against negative symptoms.

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How a community-based program for SMI pivoted during the pandemic

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For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House
Dr. Ashwin Vasan addresses Fountain House supporters in late 2019 in front of artwork, 'Stand Up, 2019' by Miguel Colón, Fountain House member and gallery artist.

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Dr. Robert T. London


“They can work with staff, learn skills regarding potential work, housekeeping, [and] social skills,” he said. One of the biggest problems facing people with SMI is they’re very isolated, Dr. London continued. “When you’re in a facility like Fountain House, you’re not isolated. You’re with fellow members, a very helpful educated staff, and you’re going to do well.” If a member is having some issues and losing touch with reality and needs to find treatment, Fountain House will provide that support.

“If you don’t have a treating person, they’re going to find you one. They’re not against traditional medical/psychiatric care,” he said.

Among those with unstable or no housing, 99% find housing within a year of joining Fountain House. While it does provide people with SMI with support to find a roof over their heads, Fountain House doesn’t necessarily fit a model of “housing first,” Stephanie Le Melle, MD, MS, director of public psychiatry education at department of psychiatry at Columbia University/New York State Psychiatric Institute, said in an interview.

Courtesy Dr. Le Melle
Dr. Stephanie Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

 

 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

 

 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage
Rich Courage shares a moment with the late artist Robin Taylor

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

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For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House
Dr. Ashwin Vasan addresses Fountain House supporters in late 2019 in front of artwork, 'Stand Up, 2019' by Miguel Colón, Fountain House member and gallery artist.

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Dr. Robert T. London


“They can work with staff, learn skills regarding potential work, housekeeping, [and] social skills,” he said. One of the biggest problems facing people with SMI is they’re very isolated, Dr. London continued. “When you’re in a facility like Fountain House, you’re not isolated. You’re with fellow members, a very helpful educated staff, and you’re going to do well.” If a member is having some issues and losing touch with reality and needs to find treatment, Fountain House will provide that support.

“If you don’t have a treating person, they’re going to find you one. They’re not against traditional medical/psychiatric care,” he said.

Among those with unstable or no housing, 99% find housing within a year of joining Fountain House. While it does provide people with SMI with support to find a roof over their heads, Fountain House doesn’t necessarily fit a model of “housing first,” Stephanie Le Melle, MD, MS, director of public psychiatry education at department of psychiatry at Columbia University/New York State Psychiatric Institute, said in an interview.

Courtesy Dr. Le Melle
Dr. Stephanie Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

 

 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

 

 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage
Rich Courage shares a moment with the late artist Robin Taylor

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

For more than 70 years, Fountain House has offered a lifeline for people living with schizophrenia, bipolar disorder, major depression, and other serious mental illnesses through a community-based model of care. When he took the helm less than 2 years ago, CEO and President Ashwin Vasan, ScM, MD, PhD, wanted a greater focus on crisis-based solutions and a wider, public health approach.

Courtesy Fountain House
Dr. Ashwin Vasan addresses Fountain House supporters in late 2019 in front of artwork, 'Stand Up, 2019' by Miguel Colón, Fountain House member and gallery artist.

That goal was put to the test in 2020, when SARS-CoV-2 shuttered all in-person activities. The nonprofit quickly rebounded, creating a digital platform, engaging with its members through online courses, face-to-face check-ins, and delivery services, and expanding partnerships to connect with individuals facing homelessness and involved in the criminal justice system. Those activities not only brought the community together – it expanded Fountain House’s footprint.

Among its membership of more than 2,000 people in New York City, about 70% connected to the digital platform. “We also enrolled more than 200 brand new members during the pandemic who had never set foot in the physical mental health “clubhouse.” They derived value as well,” Dr. Vasan said in an interview. Nationally, the program is replicated at more than 200 locations and serves about 60,000 people in almost 40 states. During the pandemic, Fountain House began formalizing affiliation opportunities with this network.

Now that the pandemic is showing signs of receding, Fountain House faces new challenges operating as a possible hybrid model. “More than three-quarters of our members say they want to continue to engage virtually as well as in person,” Dr. Vasan said. As of this writing, Fountain House is enjoying a soft reopening, slowly welcoming in-person activities. What this will look like in the coming weeks and months is a work in progress, he added. “We don’t know yet how people are going to prefer to engage.”
 

A role in the public policy conversation

Founded by a small group of former psychiatric patients in the late 1940s, Fountain House has since expanded from a single building in New York City to more than 300 replications in the United States and around the world. It originated the “clubhouse” model of mental health support: a community-based approach that helps members improve health, and break social and economic isolation by reclaiming social, educational, and work skills, and connecting with core services, including supportive housing and community-based primary and behavioral health care (Arts Psychother. 2012 Feb 39[1]:25-30).

Serious mental illness (SMI) is growing more pronounced as a crisis, not just in the people it affects, “but in all of the attendant and preventable social and economic crises that intersect with it, whether it’s increasing health care costs, homelessness, or criminalization,” Dr. Vasan said.

After 73 years, Fountain House is just beginning to gain relevance as a tool to help solve these intersecting public policy crises, he added.

“We’ve demonstrated through evaluation data that it reduces hospitalization rates, health care costs, reliance on emergency departments, homelessness, and recidivism to the criminal justice system,” he said. Health care costs for members are more than 20% lower than for others with mental illness, and recidivism rates among those with a criminal history are less than 5%.

Others familiar with Fountain House say the model delivers on its charge to improve quality of life for people with SMI.

It’s a great referral source for people who are under good mental health control, whether it’s therapy or a combination of therapy and medications, Robert T. London, MD, a practicing psychiatrist in New York who is not affiliated with Fountain House but has referred patients to the organization over the years, said in an interview.

Dr. Robert T. London


“They can work with staff, learn skills regarding potential work, housekeeping, [and] social skills,” he said. One of the biggest problems facing people with SMI is they’re very isolated, Dr. London continued. “When you’re in a facility like Fountain House, you’re not isolated. You’re with fellow members, a very helpful educated staff, and you’re going to do well.” If a member is having some issues and losing touch with reality and needs to find treatment, Fountain House will provide that support.

“If you don’t have a treating person, they’re going to find you one. They’re not against traditional medical/psychiatric care,” he said.

Among those with unstable or no housing, 99% find housing within a year of joining Fountain House. While it does provide people with SMI with support to find a roof over their heads, Fountain House doesn’t necessarily fit a model of “housing first,” Stephanie Le Melle, MD, MS, director of public psychiatry education at department of psychiatry at Columbia University/New York State Psychiatric Institute, said in an interview.

Courtesy Dr. Le Melle
Dr. Stephanie Le Melle

“The housing first evidence-based model, as designed and implemented by Pathways to Housing program in New York in the early 90s, accepted people who were street homeless or in shelters, not involved in mental health treatment, and actively using substances into scatter-site apartments and wrapped services around them,” she said.

Dr. Le Melle, who is not affiliated with Fountain House, views it more as a supportive employment program that uses a recovery-oriented, community-based, jointly peer-run approach to engage members in vocational/educational programming. It also happens to have some supportive housing for its members, she added.

Dr. Vasan believes Fountain House could expand beyond a community model. The organization has been moving out from its history, evolving into a model that could be integrated as standard of care and standard of practice for community health, he said. Fountain House is part of Clubhouse International, an umbrella organization that received the American Psychiatric Association’s 2021 special presidential commendation award during its virtual annual meeting for the group’s use of “the evidence-based, cost-effective clubhouse model of psychosocial rehabilitation as a leading recovery resource for people living with mental illness around the world.”
 

 

 

How medication issues are handled

Fountain House doesn’t directly provide medication to its members. According to Dr. Vasan, psychiatric care is just one component of recovery for serious mental illness.

“We talk about Fountain House as a main vortex in a triangle of recovery. You need health care, housing, and community. The part that’s been neglected the most is community intervention, the social infrastructure for people who are deeply isolated and marginalized,” he said. “We know that people who have that infrastructure, and are stably housed, are then more likely to engage in community-based psychiatry and primary care. And in turn, people who are in stable clinical care can more durably engage in the community programming Fountain House offers.”

Health care and clinical care are changing. It’s becoming more person-centered and community based. “We need to move with the times and we have, in the last 2 decades,” he said.

Historically, Fountain House has owned and operated its own clinic in New York City. More recently, it partnered with Sun River Health and Ryan Health, two large federally qualified health center networks in New York, so that members receive access to psychiatric and medical care. It has also expanded similar partnerships with Columbia University, New York University, and other health care systems to ensure its members have access to sustainable clinical care as a part of the community conditions and resources needed to recover and thrive.

Those familiar with the organization don’t see the absence of a medication program as a negative factor. If Fountain House doesn’t provide psychiatric medications, “that tells me the patients are under control and able to function in a community setting” that focuses on rehabilitation, Dr. London said.

It’s true that psychiatric medication treatment is an essential part of a patient’s recovery journey, Dr. Le Melle said. “Treatment with medications can be done in a recovery-oriented way. However, the Fountain House model has been designed to keep these separate, and this model works well for most” of the members.

As long as members and staff are willing to collaborate with treatment providers outside of the clubhouse, when necessary, this model of separation between work and treatment can work really well, she added.

“There are some people who need a more integrated system of care. There is no ‘one size fits all’ program that can meet everyone’s needs,” said Dr. Le Melle. The absence of onsite treatment at Fountain House, to some extent “adds to the milieu and allows people to focus on other aspects of their lives besides their illness.”

This hasn’t always been the case in traditionally funded behavioral health programs, she continued. Most mental health clinics, because of fiscal structures, reimbursement, and staffing costs, focus more on psychotherapy and medication management than on other aspects of peoples’ lives, such as their recovery goals.

The bottom line is rehabilitation in medicine works – whether it’s for a mental health disorder, broken leg, arm, or stroke, Dr. London said. “Fountain House’s focus is integrating a person into society by helping them to think differently and interact socially in groups and learn some skills.”

Through cognitive-behavioral therapies, a person with mental illness can learn how to act differently. “The brain is always in a growing process where you learn and develop new ideas, make connections,” Dr. London said. “New protein molecules get created and stored; changes occur with the neurotransmitters.”

Overall, the Fountain House model is great for supporting and engaging people with serious mental illness, Dr. Le Melle said. “It provides a literal place, a community, and a safe environment that helps people to embrace their recovery journey. It is also great at supporting people in their engagement with vocational training and employment.”

Ideally, she would like Fountain House to grow and become more inclusive by engaging people who live with both mental illness and substance use.
 

 

 

COVID-19 changes the rules

The most difficult challenge for health care and other institutions is to keep individuals with SMI engaged and visible so that they can find access to health care and benefits – and avoid acute hospitalization or medical care. “That’s our goal, to prevent the worst effects and respond accordingly,” Dr. Vasan said.

SARS-CoV-2 forced the program to reevaluate its daily operations so that it could maintain crucial connections with its members.

Dr. Vasan and his staff immediately closed the clubhouse when COVID-19 first hit, transitioning to direct community-based services that provided one-on-one outreach, and meal, medication, and clothing delivery. “Even if people couldn’t visit our clubhouse, we wanted them to feel that sense of community connection, even if it was to drop off meals at their doorstep,” he said.

Donning personal protective equipment, his staff and interested program participants went out into the communities to do this personal outreach. At the height of pandemic in New York City, “we weren’t sure what to do,” as far as keeping safe, he admitted. Nevertheless, he believes this outreach work was lifesaving in that it kept people connected to the clubhouse.

As Fountain House worked to maintain in-person contact, it also built a digital community to keep the live community together. This wasn’t just about posting on a Facebook page – it was interactive, Dr. Vasan noted. An online group made masks for the community and sold them for people outside of Fountain House. Capacity building courses instructed members on writing resumes, looking for jobs, or filling out applications.

There’s an assumption that people with SMI lack the skills to navigate technology. Some of the hallmarks of SMI are demotivation and lack of confidence, and logging onto platforms and email can be challenging for some people, he acknowledged. Over the last 18 months, Fountain House’s virtual clubhouse proved this theory wrong, Dr. Vasan said. “There are a great number of people with serious mental illness who have basic digital skills and are already using technology, or are very eager to learn,” he said.

For the subset of members who did get discouraged by the virtual platform, Fountain House responded by giving them one-on-one home support and digital literacy training to help them stay motivated and engaged.

Fountain House also expanded partnerships during the pandemic, working with programs such as the Fortune Society to bring people with SMI from the criminal justice system into Fountain House. “We’re doing this either virtually or through outdoor, public park programs with groups such as the Times Square Alliance and Fort Greene Park Conservancy to ensure we’re meeting people where they are, at a time of a rising health crisis,” Dr. Vasan said.
 

Moving on to a hybrid model

At the height of the pandemic, it was easy to engage members through creative programming. People were craving socialization. Now that people are getting vaccinated and interacting inside and outside, some understandable apathy is forming toward digital platforms, Dr. Vasan said.

“The onus is on us now to look at that data and to design something new that can keep people engaged in a hybrid model,” he added.

June 14, 2021, marked Fountain House’s soft opening. “This was a big day for us, to work through the kinks,” he said. At press time, the plan was to fully reopen the clubhouse in a few weeks – if transmission and case rates stay low.

It’s unclear at this point how many people will engage with Fountain House on a daily, in-person basis. Some people might want to come to the clubhouse just a few days a week and use the online platform on other days.

“We’re doing a series of experiments to really understand what different offerings we need to make. For example, perhaps we need to have 24-7 programming on the digital platform. That way, you could access it on demand,” said Dr. Vasan. The goal is to create a menu of choices for members so that it becomes flexible and meets their needs.

Long term, Dr. Vasan hopes the digital platform will become a scalable technology. “We want this to be used not just by Fountain House, but for programs and in markets that don’t have clubhouses.” Health systems or insurance companies would benefit from software like this because it addresses one of the most difficult aspects for this population: keeping them engaged and visible to their systems, Dr. Vasan added.

“I think the most important lesson here is we’re designing for a group of people that no one designs for. No one’s paying attention to people with serious mental illness. Nor have they ever, really. Fountain House has always been their advocate and partner. It’s great that we can do this with them, and for them.”

Dr. Vasan, also an epidemiologist, serves as assistant professor of clinical population, and family health and medicine, at Columbia University. Dr. London and Dr. Le Melle have no conflicts of interest.
 

Two steps back, three steps forward

For some of its members, Fountain House provides more than just a sense of place. In an interview, longtime member and New York City native Rich Courage, 61, discussed his mental illness challenges and the role the organization played in reclaiming his life, leading to a new career as a counselor.

Courtesy Rich Courage
Rich Courage shares a moment with the late artist Robin Taylor

Question: What made you seek out Fountain House? Are you still a member?

Rich Courage: I’ve been a member since 2001. I was in a day program at Postgraduate, on West 36th Street. They had this huge theater program, and I was a part of that. But the program fell apart and I didn’t know what to do with myself. A friend of mine told me about Fountain House. I asked what it did, and the friend said that it puts people with mental health challenges back to life, to work, to school. I was making some art, some collages, and I heard they had an art gallery.

Seeing Fountain House, I was amazed. It was this very friendly, warm, cozy place. The staff was nice; the members were welcoming. The next thing you know it’s 2021, and here I am, a peer counselor at Fountain House. I work on “the warm line,” doing the evening shift. People call in who have crises, but a lot of them call in because they’re lonely and want someone to talk to. As a peer counselor, I don’t tell people what to do, but I do offer support. I encourage. I ask questions that enable them to figure out their own problems. And I tell stories anecdotally of people that I’ve known and about recovery.

I struggled with bad depression when I was in my 20s. My mother died, and I lost everything. Coming to Fountain House and being part of this community is unlike anything I’d ever experienced. People weren’t just sitting around and talking about their problems; they were doing something about it. They were going back to school, to work, to social engagements, and the world at large. And it wasn’t perfect or linear. It was two steps back, three steps forward.

That’s exactly what I was doing. I had a lot of self-esteem and confidence issues, and behavioral stuff. My mind was wired a certain way. I had hospitalizations; I was in psychiatric wards. I had a suicide attempt in 2006, which was nearly successful. I was feeling social, mental, and emotional pain for so long. The community has been invaluable for me. Hearing other people’s stories, being accepted, has been wonderful.

I’ve been down and now I’m up, on an upward trajectory.
 

Question: How else has Fountain House made a difference in your life?

RC: I’m in a Fountain House residence in a one-bedroom, and it’s the most stable housing I’ve ever had in 61 years. So I’ve gotten housing and I’ve gotten a job, which is all great, because it’s aided me in becoming a full human being. But it’s really eased my suffering and enabled me to feel some joy and have some life instead of this shadow existence that I had been living for 30 years.

Fountain House has different units, and I’ve been in the communications unit – we put out the weekly paper and handle all the mail. The unit has computers, and I was able to work on my writing. I wrote a play called "The Very Last Dance of Homeless Joe." We’ve had staged readings at Fountain House, and 200 people have seen it over 2 years. We Zoomed it through the virtual community. It was very successful. A recording of the staged reading won third place at a festival in Florida.

In September, it will be an off-Broadway show. It’s a play about the homeless, but it’s not depressing; it’s very uplifting.
 

Question: Did you stay connected to Fountain House during the pandemic, either through the digital community or through services they provided? What was this experience like for you?

RC: Ashwin [Vasan] had been here 6 months, and he saw the pandemic coming. During a programming meeting he said, “We need a virtual community, and we need it now.” None of us knew what Zoom was, how the mute button worked. But it’s been wonderful for me. I’m a performer, so I was able to get on to Facebook every day and post a song. Some of it was spoofs about COVID; some were dedications to members. I ended up connecting with a member in Minnesota who used to be a neighbor of mine. We had lost contact, and we reconnected through Fountain House.

Question: What would you tell someone who might need this service?

RC: We’ve partially reopened the clubhouse. In July we’ll be doing tours again. I’d say, come take a tour and see the different social, economic, housing, and educational opportunities. We have a home and garden unit that decorates the place. We have a gym, a wellness unit. But these are just things. The real heart is the people.

As a unit leader recently told me, “We’re not a clinic. We’re not a revolving door. We forge relationships with members that last in our hearts and minds for a lifetime. Even if it’s not in my job description, if there’s anything in my power that I could do to help a member ease their suffering, I will do it.”

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