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Blood biomarker a ‘promising’ predictor of psychosis relapse
Copeptin, a small peptide secreted with the hormone vasopressin, appears to be one of the first promising biomarkers for predicting psychosis relapse, results of an observational study suggest.
An analysis of plasma copeptin levels in patients with schizophrenia showed those with high plasma levels of the peptide were about three times more likely to experience psychotic relapse, compared with their counterparts with lower levels.
The results suggest, “copeptin could be a promising biomarker in predicting psychotic relapse in schizophrenia spectrum disorder,” said study investigator Jennifer Küster, MD, University Psychiatric Clinics Basel (Switzerland). Measuring copeptin levels upon hospital admission “could help to intensify” the care of at-risk patients, she added.
The findings were presented at the virtual Congress of the Schizophrenia International Research Society 2021.
Relapse prevention important
Two-thirds of patients with schizophrenia experience at least one relapse of a psychotic episode, which in turn increases the risk of the disorder having a chronic course, Dr. Küster noted.
In addition, a psychotic relapse is associated with deterioration of function and cognition and reduced treatment response, “so relapse prevention is important,” she said.
Previous research has explored various methods of predicting schizophrenia outcomes. These include measuring inflammatory markers, catecholamines, oxytocin, and cortisol in combination with imaging markers, “but so far no reliable biomarker has been found,” Dr. Küster said.
She noted that psychotic relapse is associated with increased psychological stress – and vasopressin, which is secreted by the pituitary gland, is a known marker of stress. It is involved in sodium homeostasis and higher brain function and is also elevated in acute psychosis.
However, vasopressin “is challenging to measure because assays are complicated and unreliable,” Dr. Küster said.
As a result, the researchers turned their attention to copeptin, a more stable, more reliable surrogate marker for vasopressin. Copeptin has been shown previously to be a predictor of outcomes in somatic diseases and is also increased during psychological distress.
To measure the utility of copeptin in predicting psychotic relapse,
Baseline characteristics were collected and fasting serum copeptin levels were measured. Disease severity was measured using a range of validated assessment scales.
Predictive factor
Among 69 patients available for analysis, 30 experienced psychotic relapse at 1-year follow-up. Relapse was defined as rehospitalization because of an acute psychotic episode.
There were no differences in baseline demographic characteristics between patients with, and without, psychotic relapse. There were also no differences in baseline psychopathology, including scores on the Positive and Negative Syndrome Scale, the Beck Depression Inventory, and the Global Assessment of Function.
Dr. Küster noted that there were no overall differences between patients with and without psychotic relapse in terms of their plasma copeptin or cortisol levels at baseline.
“The only difference we saw was in diagnosis,” she reported. Patients with psychotic relapse were significantly more likely to have comorbid drug abuse – 43% in patients who relapsed versus 15% of those who did not (P = .02).
However, when the investigators calculated the area under the receiver operating characteristics curve for copeptin levels, they found there was a significant difference in relapse rates in those with copeptin levels >6 pmol/L vs. those with lower levels (hazard ratio, 2.3; P = .039).
When the focus was on only patients with schizophrenia spectrum disorder, the results were even more pronounced. The HR for psychotic relapse in patients with higher vs. lower copeptin levels was 3.2 (P = .028).
“We also looked for other possible predicting factors,” Dr. Küster said. This included sex, age, duration of disease, reason for hospitalization, psychopathology, medication, comorbidities, and cortisol levels. “But none of these factors was associated with psychotic relapse,” she added.
The only factor positively associated with relapse was drug abuse, primarily via marijuana. However, the association with copeptin remained significant even after taking this factor into account.
In future studies, the researchers plan to examine whether copeptin levels could identify which patients at ultra-high risk will transition to first-episode psychosis, as well as to predict development of posttraumatic stress disorder, Dr. Küster said.
A proxy for ‘something simpler’?
Commenting on the findings for this news organization, Leah H. Rubin, PhD, associate professor of neurology, Johns Hopkins University, Baltimore, described the study as “interesting” – and noted that her own research has included measuring vasopressin in patients with untreated first-episode psychosis.
Dr. Rubin’s findings showed that levels of the hormone were associated with psychosis severity, and thus she is “not surprised that they found a marker” that may be promising in psychosis relapse prediction.
However, she took issue with the notion that vasopressin is an unreliable marker, pointing out that the work of her team demonstrates that it can be measured. Dr. Rubin added that she found it to be “pretty stable.”
In addition, because the current study had a small sample size, Dr. Rubin said she would be interested to see whether the findings can be replicated on a larger scale.
She also noted that more than two-thirds of the study population were men. “Vasopressin and oxytocin are sexually dimorphic neuropeptides,” she explained, “so I think it becomes important to ensure ... whether it’s the same for men and women.”
“Just from a psychosocial perspective, what’s going on in those folks’ lives?” Dr. Rubin asked. “Is it truly copeptin” or is it high stress levels that facilitate a relapse? Copeptin levels, she added, may be “a proxy for something simpler.”
The study authors and Dr. Rubin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Copeptin, a small peptide secreted with the hormone vasopressin, appears to be one of the first promising biomarkers for predicting psychosis relapse, results of an observational study suggest.
An analysis of plasma copeptin levels in patients with schizophrenia showed those with high plasma levels of the peptide were about three times more likely to experience psychotic relapse, compared with their counterparts with lower levels.
The results suggest, “copeptin could be a promising biomarker in predicting psychotic relapse in schizophrenia spectrum disorder,” said study investigator Jennifer Küster, MD, University Psychiatric Clinics Basel (Switzerland). Measuring copeptin levels upon hospital admission “could help to intensify” the care of at-risk patients, she added.
The findings were presented at the virtual Congress of the Schizophrenia International Research Society 2021.
Relapse prevention important
Two-thirds of patients with schizophrenia experience at least one relapse of a psychotic episode, which in turn increases the risk of the disorder having a chronic course, Dr. Küster noted.
In addition, a psychotic relapse is associated with deterioration of function and cognition and reduced treatment response, “so relapse prevention is important,” she said.
Previous research has explored various methods of predicting schizophrenia outcomes. These include measuring inflammatory markers, catecholamines, oxytocin, and cortisol in combination with imaging markers, “but so far no reliable biomarker has been found,” Dr. Küster said.
She noted that psychotic relapse is associated with increased psychological stress – and vasopressin, which is secreted by the pituitary gland, is a known marker of stress. It is involved in sodium homeostasis and higher brain function and is also elevated in acute psychosis.
However, vasopressin “is challenging to measure because assays are complicated and unreliable,” Dr. Küster said.
As a result, the researchers turned their attention to copeptin, a more stable, more reliable surrogate marker for vasopressin. Copeptin has been shown previously to be a predictor of outcomes in somatic diseases and is also increased during psychological distress.
To measure the utility of copeptin in predicting psychotic relapse,
Baseline characteristics were collected and fasting serum copeptin levels were measured. Disease severity was measured using a range of validated assessment scales.
Predictive factor
Among 69 patients available for analysis, 30 experienced psychotic relapse at 1-year follow-up. Relapse was defined as rehospitalization because of an acute psychotic episode.
There were no differences in baseline demographic characteristics between patients with, and without, psychotic relapse. There were also no differences in baseline psychopathology, including scores on the Positive and Negative Syndrome Scale, the Beck Depression Inventory, and the Global Assessment of Function.
Dr. Küster noted that there were no overall differences between patients with and without psychotic relapse in terms of their plasma copeptin or cortisol levels at baseline.
“The only difference we saw was in diagnosis,” she reported. Patients with psychotic relapse were significantly more likely to have comorbid drug abuse – 43% in patients who relapsed versus 15% of those who did not (P = .02).
However, when the investigators calculated the area under the receiver operating characteristics curve for copeptin levels, they found there was a significant difference in relapse rates in those with copeptin levels >6 pmol/L vs. those with lower levels (hazard ratio, 2.3; P = .039).
When the focus was on only patients with schizophrenia spectrum disorder, the results were even more pronounced. The HR for psychotic relapse in patients with higher vs. lower copeptin levels was 3.2 (P = .028).
“We also looked for other possible predicting factors,” Dr. Küster said. This included sex, age, duration of disease, reason for hospitalization, psychopathology, medication, comorbidities, and cortisol levels. “But none of these factors was associated with psychotic relapse,” she added.
The only factor positively associated with relapse was drug abuse, primarily via marijuana. However, the association with copeptin remained significant even after taking this factor into account.
In future studies, the researchers plan to examine whether copeptin levels could identify which patients at ultra-high risk will transition to first-episode psychosis, as well as to predict development of posttraumatic stress disorder, Dr. Küster said.
A proxy for ‘something simpler’?
Commenting on the findings for this news organization, Leah H. Rubin, PhD, associate professor of neurology, Johns Hopkins University, Baltimore, described the study as “interesting” – and noted that her own research has included measuring vasopressin in patients with untreated first-episode psychosis.
Dr. Rubin’s findings showed that levels of the hormone were associated with psychosis severity, and thus she is “not surprised that they found a marker” that may be promising in psychosis relapse prediction.
However, she took issue with the notion that vasopressin is an unreliable marker, pointing out that the work of her team demonstrates that it can be measured. Dr. Rubin added that she found it to be “pretty stable.”
In addition, because the current study had a small sample size, Dr. Rubin said she would be interested to see whether the findings can be replicated on a larger scale.
She also noted that more than two-thirds of the study population were men. “Vasopressin and oxytocin are sexually dimorphic neuropeptides,” she explained, “so I think it becomes important to ensure ... whether it’s the same for men and women.”
“Just from a psychosocial perspective, what’s going on in those folks’ lives?” Dr. Rubin asked. “Is it truly copeptin” or is it high stress levels that facilitate a relapse? Copeptin levels, she added, may be “a proxy for something simpler.”
The study authors and Dr. Rubin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Copeptin, a small peptide secreted with the hormone vasopressin, appears to be one of the first promising biomarkers for predicting psychosis relapse, results of an observational study suggest.
An analysis of plasma copeptin levels in patients with schizophrenia showed those with high plasma levels of the peptide were about three times more likely to experience psychotic relapse, compared with their counterparts with lower levels.
The results suggest, “copeptin could be a promising biomarker in predicting psychotic relapse in schizophrenia spectrum disorder,” said study investigator Jennifer Küster, MD, University Psychiatric Clinics Basel (Switzerland). Measuring copeptin levels upon hospital admission “could help to intensify” the care of at-risk patients, she added.
The findings were presented at the virtual Congress of the Schizophrenia International Research Society 2021.
Relapse prevention important
Two-thirds of patients with schizophrenia experience at least one relapse of a psychotic episode, which in turn increases the risk of the disorder having a chronic course, Dr. Küster noted.
In addition, a psychotic relapse is associated with deterioration of function and cognition and reduced treatment response, “so relapse prevention is important,” she said.
Previous research has explored various methods of predicting schizophrenia outcomes. These include measuring inflammatory markers, catecholamines, oxytocin, and cortisol in combination with imaging markers, “but so far no reliable biomarker has been found,” Dr. Küster said.
She noted that psychotic relapse is associated with increased psychological stress – and vasopressin, which is secreted by the pituitary gland, is a known marker of stress. It is involved in sodium homeostasis and higher brain function and is also elevated in acute psychosis.
However, vasopressin “is challenging to measure because assays are complicated and unreliable,” Dr. Küster said.
As a result, the researchers turned their attention to copeptin, a more stable, more reliable surrogate marker for vasopressin. Copeptin has been shown previously to be a predictor of outcomes in somatic diseases and is also increased during psychological distress.
To measure the utility of copeptin in predicting psychotic relapse,
Baseline characteristics were collected and fasting serum copeptin levels were measured. Disease severity was measured using a range of validated assessment scales.
Predictive factor
Among 69 patients available for analysis, 30 experienced psychotic relapse at 1-year follow-up. Relapse was defined as rehospitalization because of an acute psychotic episode.
There were no differences in baseline demographic characteristics between patients with, and without, psychotic relapse. There were also no differences in baseline psychopathology, including scores on the Positive and Negative Syndrome Scale, the Beck Depression Inventory, and the Global Assessment of Function.
Dr. Küster noted that there were no overall differences between patients with and without psychotic relapse in terms of their plasma copeptin or cortisol levels at baseline.
“The only difference we saw was in diagnosis,” she reported. Patients with psychotic relapse were significantly more likely to have comorbid drug abuse – 43% in patients who relapsed versus 15% of those who did not (P = .02).
However, when the investigators calculated the area under the receiver operating characteristics curve for copeptin levels, they found there was a significant difference in relapse rates in those with copeptin levels >6 pmol/L vs. those with lower levels (hazard ratio, 2.3; P = .039).
When the focus was on only patients with schizophrenia spectrum disorder, the results were even more pronounced. The HR for psychotic relapse in patients with higher vs. lower copeptin levels was 3.2 (P = .028).
“We also looked for other possible predicting factors,” Dr. Küster said. This included sex, age, duration of disease, reason for hospitalization, psychopathology, medication, comorbidities, and cortisol levels. “But none of these factors was associated with psychotic relapse,” she added.
The only factor positively associated with relapse was drug abuse, primarily via marijuana. However, the association with copeptin remained significant even after taking this factor into account.
In future studies, the researchers plan to examine whether copeptin levels could identify which patients at ultra-high risk will transition to first-episode psychosis, as well as to predict development of posttraumatic stress disorder, Dr. Küster said.
A proxy for ‘something simpler’?
Commenting on the findings for this news organization, Leah H. Rubin, PhD, associate professor of neurology, Johns Hopkins University, Baltimore, described the study as “interesting” – and noted that her own research has included measuring vasopressin in patients with untreated first-episode psychosis.
Dr. Rubin’s findings showed that levels of the hormone were associated with psychosis severity, and thus she is “not surprised that they found a marker” that may be promising in psychosis relapse prediction.
However, she took issue with the notion that vasopressin is an unreliable marker, pointing out that the work of her team demonstrates that it can be measured. Dr. Rubin added that she found it to be “pretty stable.”
In addition, because the current study had a small sample size, Dr. Rubin said she would be interested to see whether the findings can be replicated on a larger scale.
She also noted that more than two-thirds of the study population were men. “Vasopressin and oxytocin are sexually dimorphic neuropeptides,” she explained, “so I think it becomes important to ensure ... whether it’s the same for men and women.”
“Just from a psychosocial perspective, what’s going on in those folks’ lives?” Dr. Rubin asked. “Is it truly copeptin” or is it high stress levels that facilitate a relapse? Copeptin levels, she added, may be “a proxy for something simpler.”
The study authors and Dr. Rubin have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Motor abnormalities in children a harbinger of serious mental illness?
Motor problems in children may be a harbinger of serious mental illness, new research suggests.
Investigators found that motor abnormalities were twice as common among those who develop psychosis or depression, compared with their counterparts in the general population, suggesting that these abnormalities may help predict vulnerability and provide an opportunity for early intervention.
“We have learned there are motor signs that are measurable in adolescence [that are] more prevalent in these disorders,” said lead investigator Katherine S. F. Damme, PhD, adolescent development and preventive treatment program (ADAPT), Northwestern University, Chicago. 
“This is just scratching the surface of motor signs, but they may have some transdiagnostic vulnerability across these psychopathologies” to which sensorimotor connectivity and motor behaviors “might provide additional insight,” Dr. Damme added.
The findings were presented at the Virtual Congress of the Schizophrenia International Research Society 2021.
A core symptom
There has been a lot of interest in the pathophysiology of psychosis and in detecting it early, said Dr. Damme. “It has devastating effects, and early intervention is of great importance,” she added.
However, previous research has typically focused on affect or cognition, rather than on motor signs, despite the fact that motor signs are a “core symptom of both psychosis and depression.”
The prevalence and presentation of motor signs in adolescence, which is a “critical time for identifying these risk markers” because of their proximity to the onset of psychosis, has been understudied, Dr. Damme said.
For their study, the investigators gathered motor function data from the Adolescent Brain Cognitive Development Study (ABCD), which included 10,835 children aged 9-11 years with broad demographic diversity from 21 sites across the United States.
Overall, 27.6% of the children were reported to have least one motor sign; approximately 3% were reported to have two or more motor signs.
The most common of these was dyscoordination, which was endorsed by 19.3% of participants. In addition, 8.8% were reported to have had experienced developmental motor delays, 1.5% had psychomotor agitation, and 0.3% had psychomotor retardation.
The investigators determined that 4.6% of participants met criteria for depression, 2.6% for a psychosis, and 1.8% for comorbid psychosis and depression.
Motor signs were much more common among children with depression, psychosis, or both than among those who did not have these conditions; 45.8% reported having at least one motor sign.
Developmental motor delays and dyscoordination occurred at about the same rate in both patients with depression and those with psychosis. Rates were higher among patients with both of these conditions than among those with either condition alone.
In contrast, psychomotor agitation was more common among patients with depression alone and among those with comorbid depression and psychosis than among patients with psychosis alone. The rate of psychomotor retardation was increased among patients with psychosis alone but was less common among patients with comorbidity than in the healthy control group.
Familial vulnerability
The investigators also assessed participants who had not been diagnosed with a mental illness but who had a family history of depression only (28.9%), a relative with psychosis-like experiences (0.6%), or a family history of both depression and psychosis experiences (1.8%).
Although the effect size was smaller, there was a higher rate of motor signs among participants with a family history of these conditions, Dr. Damme said. “Again, we see that it’s elevated across developmental motor delays and at a similar rate in people who have depression and psychosis.”
In addition, psychomotor agitation was linked to depression with psychosis and depression without it.
Sensorimotor connectivity network data for the cohort indicated there was no main effect of diagnosis on corticostriatal connectivity.
However, more depressive symptoms were related to less connectivity (P = .024). There was a similar finding for psychotic-like experiences. The total number of such experiences related to lower connectivity (P < .001).
During the postpresentation discussion, Ian Kelleher, MD, PhD, honorary clinical lecturer in psychiatry at the Royal College of Surgeons in Ireland, Dublin, said he was “surprised” by the finding that the rate of psychomotor retardation was lower among participants with psychosis and depression.
Dr. Damme noted that some of the motor sign item ratings came by way of a child interview and that some of these item ratings came from the adults in the children’s lives.
She added that she was not entirely sure whether asking an 8- to 11-year-old in a clinical interview whether they are experiencing motor signs “might be the best way to get at motor slowing.”
Subtle features
Commenting on the findings in an interview, Peter F. Liddle, MD, PhD, professor of psychiatry, at the University of Nottingham (England), noted that the “features we’re talking about are pretty subtle.
“What I’ve been wondering about for some time is whether we should be getting video recordings and using machine learning approaches to teach a computer to recognize normal movements vs abnormal movements, and particularly facial expression,” said Dr. Liddle, who was not involved with the research.
He called the current study “interesting” but noted several factors that affect the potential utility of the findings in predicting outcomes.
First, they “may not be very good for distinguishing schizophrenia from mood disorders; but if the question is simply determining which young person might go on to develop a significant mental disorder, then it may be useful,” Dr. Liddle said.
He endorsed the investigators’ conclusion that motor abnormalities may be a transdiagnostic marker. Beyond that, they may be “more useful as a predictor of the likely long-term severity, but that’s my own hypothesis based on my work,” he added.
Another question concerns the sensitivity of motor abnormalities as a predictive marker. With the rate of the abnormalities identified in those who developed psychosis and depression about double the rate in the overall population, “it sounds like those assessors were fairly sensitive. … but not all that specific,” said Dr. Liddle.
A third issue relates to treatment. “By the time people get sent to a psychiatrist for assessment for possible impending psychotic illness, they’ve often already had medication,” typically an antidepressant or antipsychotic.
“It’s very well established that dopamine-blocking antipsychotics produce hypokinesia and also dyskinesia,” which could then become a confounding factor, Dr. Liddle said.
The study was funded by grants from the National Institute of Mental Health. The study authors and Dr. Liddle have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Motor problems in children may be a harbinger of serious mental illness, new research suggests.
Investigators found that motor abnormalities were twice as common among those who develop psychosis or depression, compared with their counterparts in the general population, suggesting that these abnormalities may help predict vulnerability and provide an opportunity for early intervention.
“We have learned there are motor signs that are measurable in adolescence [that are] more prevalent in these disorders,” said lead investigator Katherine S. F. Damme, PhD, adolescent development and preventive treatment program (ADAPT), Northwestern University, Chicago.
“This is just scratching the surface of motor signs, but they may have some transdiagnostic vulnerability across these psychopathologies” to which sensorimotor connectivity and motor behaviors “might provide additional insight,” Dr. Damme added.
The findings were presented at the Virtual Congress of the Schizophrenia International Research Society 2021.
A core symptom
There has been a lot of interest in the pathophysiology of psychosis and in detecting it early, said Dr. Damme. “It has devastating effects, and early intervention is of great importance,” she added.
However, previous research has typically focused on affect or cognition, rather than on motor signs, despite the fact that motor signs are a “core symptom of both psychosis and depression.”
The prevalence and presentation of motor signs in adolescence, which is a “critical time for identifying these risk markers” because of their proximity to the onset of psychosis, has been understudied, Dr. Damme said.
For their study, the investigators gathered motor function data from the Adolescent Brain Cognitive Development Study (ABCD), which included 10,835 children aged 9-11 years with broad demographic diversity from 21 sites across the United States.
Overall, 27.6% of the children were reported to have least one motor sign; approximately 3% were reported to have two or more motor signs.
The most common of these was dyscoordination, which was endorsed by 19.3% of participants. In addition, 8.8% were reported to have had experienced developmental motor delays, 1.5% had psychomotor agitation, and 0.3% had psychomotor retardation.
The investigators determined that 4.6% of participants met criteria for depression, 2.6% for a psychosis, and 1.8% for comorbid psychosis and depression.
Motor signs were much more common among children with depression, psychosis, or both than among those who did not have these conditions; 45.8% reported having at least one motor sign.
Developmental motor delays and dyscoordination occurred at about the same rate in both patients with depression and those with psychosis. Rates were higher among patients with both of these conditions than among those with either condition alone.
In contrast, psychomotor agitation was more common among patients with depression alone and among those with comorbid depression and psychosis than among patients with psychosis alone. The rate of psychomotor retardation was increased among patients with psychosis alone but was less common among patients with comorbidity than in the healthy control group.
Familial vulnerability
The investigators also assessed participants who had not been diagnosed with a mental illness but who had a family history of depression only (28.9%), a relative with psychosis-like experiences (0.6%), or a family history of both depression and psychosis experiences (1.8%).
Although the effect size was smaller, there was a higher rate of motor signs among participants with a family history of these conditions, Dr. Damme said. “Again, we see that it’s elevated across developmental motor delays and at a similar rate in people who have depression and psychosis.”
In addition, psychomotor agitation was linked to depression with psychosis and depression without it.
Sensorimotor connectivity network data for the cohort indicated there was no main effect of diagnosis on corticostriatal connectivity.
However, more depressive symptoms were related to less connectivity (P = .024). There was a similar finding for psychotic-like experiences. The total number of such experiences related to lower connectivity (P < .001).
During the postpresentation discussion, Ian Kelleher, MD, PhD, honorary clinical lecturer in psychiatry at the Royal College of Surgeons in Ireland, Dublin, said he was “surprised” by the finding that the rate of psychomotor retardation was lower among participants with psychosis and depression.
Dr. Damme noted that some of the motor sign item ratings came by way of a child interview and that some of these item ratings came from the adults in the children’s lives.
She added that she was not entirely sure whether asking an 8- to 11-year-old in a clinical interview whether they are experiencing motor signs “might be the best way to get at motor slowing.”
Subtle features
Commenting on the findings in an interview, Peter F. Liddle, MD, PhD, professor of psychiatry, at the University of Nottingham (England), noted that the “features we’re talking about are pretty subtle.
“What I’ve been wondering about for some time is whether we should be getting video recordings and using machine learning approaches to teach a computer to recognize normal movements vs abnormal movements, and particularly facial expression,” said Dr. Liddle, who was not involved with the research.
He called the current study “interesting” but noted several factors that affect the potential utility of the findings in predicting outcomes.
First, they “may not be very good for distinguishing schizophrenia from mood disorders; but if the question is simply determining which young person might go on to develop a significant mental disorder, then it may be useful,” Dr. Liddle said.
He endorsed the investigators’ conclusion that motor abnormalities may be a transdiagnostic marker. Beyond that, they may be “more useful as a predictor of the likely long-term severity, but that’s my own hypothesis based on my work,” he added.
Another question concerns the sensitivity of motor abnormalities as a predictive marker. With the rate of the abnormalities identified in those who developed psychosis and depression about double the rate in the overall population, “it sounds like those assessors were fairly sensitive. … but not all that specific,” said Dr. Liddle.
A third issue relates to treatment. “By the time people get sent to a psychiatrist for assessment for possible impending psychotic illness, they’ve often already had medication,” typically an antidepressant or antipsychotic.
“It’s very well established that dopamine-blocking antipsychotics produce hypokinesia and also dyskinesia,” which could then become a confounding factor, Dr. Liddle said.
The study was funded by grants from the National Institute of Mental Health. The study authors and Dr. Liddle have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Motor problems in children may be a harbinger of serious mental illness, new research suggests.
Investigators found that motor abnormalities were twice as common among those who develop psychosis or depression, compared with their counterparts in the general population, suggesting that these abnormalities may help predict vulnerability and provide an opportunity for early intervention.
“We have learned there are motor signs that are measurable in adolescence [that are] more prevalent in these disorders,” said lead investigator Katherine S. F. Damme, PhD, adolescent development and preventive treatment program (ADAPT), Northwestern University, Chicago.
“This is just scratching the surface of motor signs, but they may have some transdiagnostic vulnerability across these psychopathologies” to which sensorimotor connectivity and motor behaviors “might provide additional insight,” Dr. Damme added.
The findings were presented at the Virtual Congress of the Schizophrenia International Research Society 2021.
A core symptom
There has been a lot of interest in the pathophysiology of psychosis and in detecting it early, said Dr. Damme. “It has devastating effects, and early intervention is of great importance,” she added.
However, previous research has typically focused on affect or cognition, rather than on motor signs, despite the fact that motor signs are a “core symptom of both psychosis and depression.”
The prevalence and presentation of motor signs in adolescence, which is a “critical time for identifying these risk markers” because of their proximity to the onset of psychosis, has been understudied, Dr. Damme said.
For their study, the investigators gathered motor function data from the Adolescent Brain Cognitive Development Study (ABCD), which included 10,835 children aged 9-11 years with broad demographic diversity from 21 sites across the United States.
Overall, 27.6% of the children were reported to have least one motor sign; approximately 3% were reported to have two or more motor signs.
The most common of these was dyscoordination, which was endorsed by 19.3% of participants. In addition, 8.8% were reported to have had experienced developmental motor delays, 1.5% had psychomotor agitation, and 0.3% had psychomotor retardation.
The investigators determined that 4.6% of participants met criteria for depression, 2.6% for a psychosis, and 1.8% for comorbid psychosis and depression.
Motor signs were much more common among children with depression, psychosis, or both than among those who did not have these conditions; 45.8% reported having at least one motor sign.
Developmental motor delays and dyscoordination occurred at about the same rate in both patients with depression and those with psychosis. Rates were higher among patients with both of these conditions than among those with either condition alone.
In contrast, psychomotor agitation was more common among patients with depression alone and among those with comorbid depression and psychosis than among patients with psychosis alone. The rate of psychomotor retardation was increased among patients with psychosis alone but was less common among patients with comorbidity than in the healthy control group.
Familial vulnerability
The investigators also assessed participants who had not been diagnosed with a mental illness but who had a family history of depression only (28.9%), a relative with psychosis-like experiences (0.6%), or a family history of both depression and psychosis experiences (1.8%).
Although the effect size was smaller, there was a higher rate of motor signs among participants with a family history of these conditions, Dr. Damme said. “Again, we see that it’s elevated across developmental motor delays and at a similar rate in people who have depression and psychosis.”
In addition, psychomotor agitation was linked to depression with psychosis and depression without it.
Sensorimotor connectivity network data for the cohort indicated there was no main effect of diagnosis on corticostriatal connectivity.
However, more depressive symptoms were related to less connectivity (P = .024). There was a similar finding for psychotic-like experiences. The total number of such experiences related to lower connectivity (P < .001).
During the postpresentation discussion, Ian Kelleher, MD, PhD, honorary clinical lecturer in psychiatry at the Royal College of Surgeons in Ireland, Dublin, said he was “surprised” by the finding that the rate of psychomotor retardation was lower among participants with psychosis and depression.
Dr. Damme noted that some of the motor sign item ratings came by way of a child interview and that some of these item ratings came from the adults in the children’s lives.
She added that she was not entirely sure whether asking an 8- to 11-year-old in a clinical interview whether they are experiencing motor signs “might be the best way to get at motor slowing.”
Subtle features
Commenting on the findings in an interview, Peter F. Liddle, MD, PhD, professor of psychiatry, at the University of Nottingham (England), noted that the “features we’re talking about are pretty subtle.
“What I’ve been wondering about for some time is whether we should be getting video recordings and using machine learning approaches to teach a computer to recognize normal movements vs abnormal movements, and particularly facial expression,” said Dr. Liddle, who was not involved with the research.
He called the current study “interesting” but noted several factors that affect the potential utility of the findings in predicting outcomes.
First, they “may not be very good for distinguishing schizophrenia from mood disorders; but if the question is simply determining which young person might go on to develop a significant mental disorder, then it may be useful,” Dr. Liddle said.
He endorsed the investigators’ conclusion that motor abnormalities may be a transdiagnostic marker. Beyond that, they may be “more useful as a predictor of the likely long-term severity, but that’s my own hypothesis based on my work,” he added.
Another question concerns the sensitivity of motor abnormalities as a predictive marker. With the rate of the abnormalities identified in those who developed psychosis and depression about double the rate in the overall population, “it sounds like those assessors were fairly sensitive. … but not all that specific,” said Dr. Liddle.
A third issue relates to treatment. “By the time people get sent to a psychiatrist for assessment for possible impending psychotic illness, they’ve often already had medication,” typically an antidepressant or antipsychotic.
“It’s very well established that dopamine-blocking antipsychotics produce hypokinesia and also dyskinesia,” which could then become a confounding factor, Dr. Liddle said.
The study was funded by grants from the National Institute of Mental Health. The study authors and Dr. Liddle have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nonpharma approach a potential ‘game changer’ in schizophrenia?
Cognitive remediation (CR), a therapy that encompasses nonpharmacologic approaches to improving cognitive function for patients with severe mental illness, may lead to significant improvement for patients with schizophrenia, new research suggests.
A systematic review of 130 worldwide studies that included almost 9,000 participants showed that CR significantly improved global cognition and global functioning. In addition, investigators identified key patient characteristics that flagged ideal candidates for the therapy.
“Because pharmacological treatment exerts limited effects on cognitive deficits, and clinical remission does not necessarily result in functional recovery, widespread implementation of CR could be a game-changer for achieving the patient’s personal recovery goals,” the researchers wrote.
“We hope that this systematic review could help clinicians understand how to make CR even more effective and even more personalized,” lead author Antonio Vita, MD, PhD, department of clinical and experimental sciences, University of Brescia, Italy, said in an interview.
Dr. Vita noted that he would also encourage clinicians to consider “proposing it for clinical practice.”
The findings were presented at the virtual congress of the Schizophrenia International Research Society (SIRS 2021) and were published simultaneously in JAMA Psychiatry.
Resistance continues
Cognition “should be a focus of treatment because most of the disability and functional consequences of the disease are related to ... neurocognitive impairment and impairment of social cognition,” Dr. Vita said.
He noted that treatments that focus on cognition are crucial for the recovery of patients with schizophrenia.
However, despite a “solid body of evidence” supporting the efficacy of CR and guideline recommendations that CR be included in psychiatric services, reluctance remains, the investigators noted.
The study’s goal was to determine optimal candidates for CR and to assess outcomes of the therapy and its four core elements:
- The presence of an active and trained therapist.
- Repeated practice of cognitive exercises.
- Structured development of cognitive strategies.
- Techniques to improve the transfer of cognitive gains to the real world, such as integrated psychosocial rehabilitation.
The investigators conducted a systematic literature search of the PubMed, Scopus, and PsychInfo databases to find relevant studies of CR published between January 2011 and February 2020. They also “hand-searched” meta-analyses, reviews, and reference lists.
Ultimately, the analysis included 130 randomized clinical trials comparing CR with a control condition in 8,851 patients with schizophrenia spectrum disorders.
Of these studies, 57 were conducted in Europe, 38 in the United States, 22 in Asia, 4 in Canada, 4 in Middle Eastern countries, 3 in Australia, and 2 in Brazil.
The mean age of the participants was 36.7 years, and 68% were men. The average age at the time of schizophrenia onset was 23.3 years, and the mean duration of illness was 13.8 years.
The average duration of CR treatment was 15.2 weeks. The four elements were well represented; each was offered to at least 71% of patients.
The comparator therapy was treatment as usual (TAU), in 34.3% of cases, or active TAU with multidisciplinary rehabilitation, in 15.2% of cases. The remaining interventions were either nonspecific (30.8%) or were devised specifically for the study (19.9%).
Results showed that CR had a significant, albeit moderate, effect on global cognition (Cohen’s d effect size, 0.29; P < .001) and global functioning (effect size, 0.22; P < .01).
Having an active and trained therapist had a significant impact on cognition and functioning (P = .04 for both), as did the structured development of cognitive strategies (P = .002 for cognition; P = .004 for functioning).
The integration of psychosocial rehabilitation also had a significant effect on functioning (P = .003).
Interventions that included all of the core elements had a “highly significant” association with global cognition (P = .02) and global functioning (P < .001), the investigators reported. Longer treatments were significantly associated with greater functional improvement (P = .006).
The investigators found that improvements were greater among patients who had fewer years of education (P = .03 for cognition; P = .02 for functioning), lower premorbid IQ scores (P = .04 for functioning), and more severe symptoms at baseline (P = .005 for cognition).
The researchers noted that CR should become more widely available because it has the “potential to be an element of standard care rather than an optional intervention targeting selected individuals.”
An overlooked treatment option
Commenting on the findings for this news organization, Alice Medalia, PhD, director of the Lieber Recovery Clinic at Columbia University Irving Medical Center, New York, noted that this study is the second large-scale analysis of the use of CR for patients with schizophrenia to come out this year. The other was published in Schizophrenia Bulletin.
“So this is a banner year for large reviews,” she said. “It’s great to have two studies like this [that] tell a very consistent story.”
Dr. Medalia, who was not involved with the research, said individuals “don’t really talk about cognition very much.”
CR, she added, is “one of an array of services that one should be providing, and the bigger picture is that every single person should have their cognitive health needs addressed.
“If someone is having problems, and it’s getting in the way of them being the kind of person they want to be and doing want they want to do, we need to intervene. How we intervene should always be in the least disruptive and intense way,” she said.
These measures could include examining sleep hygiene, adjusting medications, or introducing exercise.
“But there really does come a time for some people where cognitive remediation is going to be helpful, so it should be more available,” Dr. Medalia said.
Although increased availability is partially dependent on having enough trained therapists, the main reason CR is not more widely available is because “people just don’t think about cognition and they don’t know how to talk about it,” she noted. In addition, she said, even when it is available, clinicians don’t refer patients.
“That tells you something. The solution here is not to put a cognitive remediation program everywhere but ... to get people comfortable talking about cognition and identifying when an intervention is needed,” said Dr. Medalia.
One study author received grants from the National Institute for Health Research during the conduct of the study and is the creator of CIRCuiTs, a cognitive remediation software program. The other investigators and Dr. Medalia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cognitive remediation (CR), a therapy that encompasses nonpharmacologic approaches to improving cognitive function for patients with severe mental illness, may lead to significant improvement for patients with schizophrenia, new research suggests.
A systematic review of 130 worldwide studies that included almost 9,000 participants showed that CR significantly improved global cognition and global functioning. In addition, investigators identified key patient characteristics that flagged ideal candidates for the therapy.
“Because pharmacological treatment exerts limited effects on cognitive deficits, and clinical remission does not necessarily result in functional recovery, widespread implementation of CR could be a game-changer for achieving the patient’s personal recovery goals,” the researchers wrote.
“We hope that this systematic review could help clinicians understand how to make CR even more effective and even more personalized,” lead author Antonio Vita, MD, PhD, department of clinical and experimental sciences, University of Brescia, Italy, said in an interview.
Dr. Vita noted that he would also encourage clinicians to consider “proposing it for clinical practice.”
The findings were presented at the virtual congress of the Schizophrenia International Research Society (SIRS 2021) and were published simultaneously in JAMA Psychiatry.
Resistance continues
Cognition “should be a focus of treatment because most of the disability and functional consequences of the disease are related to ... neurocognitive impairment and impairment of social cognition,” Dr. Vita said.
He noted that treatments that focus on cognition are crucial for the recovery of patients with schizophrenia.
However, despite a “solid body of evidence” supporting the efficacy of CR and guideline recommendations that CR be included in psychiatric services, reluctance remains, the investigators noted.
The study’s goal was to determine optimal candidates for CR and to assess outcomes of the therapy and its four core elements:
- The presence of an active and trained therapist.
- Repeated practice of cognitive exercises.
- Structured development of cognitive strategies.
- Techniques to improve the transfer of cognitive gains to the real world, such as integrated psychosocial rehabilitation.
The investigators conducted a systematic literature search of the PubMed, Scopus, and PsychInfo databases to find relevant studies of CR published between January 2011 and February 2020. They also “hand-searched” meta-analyses, reviews, and reference lists.
Ultimately, the analysis included 130 randomized clinical trials comparing CR with a control condition in 8,851 patients with schizophrenia spectrum disorders.
Of these studies, 57 were conducted in Europe, 38 in the United States, 22 in Asia, 4 in Canada, 4 in Middle Eastern countries, 3 in Australia, and 2 in Brazil.
The mean age of the participants was 36.7 years, and 68% were men. The average age at the time of schizophrenia onset was 23.3 years, and the mean duration of illness was 13.8 years.
The average duration of CR treatment was 15.2 weeks. The four elements were well represented; each was offered to at least 71% of patients.
The comparator therapy was treatment as usual (TAU), in 34.3% of cases, or active TAU with multidisciplinary rehabilitation, in 15.2% of cases. The remaining interventions were either nonspecific (30.8%) or were devised specifically for the study (19.9%).
Results showed that CR had a significant, albeit moderate, effect on global cognition (Cohen’s d effect size, 0.29; P < .001) and global functioning (effect size, 0.22; P < .01).
Having an active and trained therapist had a significant impact on cognition and functioning (P = .04 for both), as did the structured development of cognitive strategies (P = .002 for cognition; P = .004 for functioning).
The integration of psychosocial rehabilitation also had a significant effect on functioning (P = .003).
Interventions that included all of the core elements had a “highly significant” association with global cognition (P = .02) and global functioning (P < .001), the investigators reported. Longer treatments were significantly associated with greater functional improvement (P = .006).
The investigators found that improvements were greater among patients who had fewer years of education (P = .03 for cognition; P = .02 for functioning), lower premorbid IQ scores (P = .04 for functioning), and more severe symptoms at baseline (P = .005 for cognition).
The researchers noted that CR should become more widely available because it has the “potential to be an element of standard care rather than an optional intervention targeting selected individuals.”
An overlooked treatment option
Commenting on the findings for this news organization, Alice Medalia, PhD, director of the Lieber Recovery Clinic at Columbia University Irving Medical Center, New York, noted that this study is the second large-scale analysis of the use of CR for patients with schizophrenia to come out this year. The other was published in Schizophrenia Bulletin.
“So this is a banner year for large reviews,” she said. “It’s great to have two studies like this [that] tell a very consistent story.”
Dr. Medalia, who was not involved with the research, said individuals “don’t really talk about cognition very much.”
CR, she added, is “one of an array of services that one should be providing, and the bigger picture is that every single person should have their cognitive health needs addressed.
“If someone is having problems, and it’s getting in the way of them being the kind of person they want to be and doing want they want to do, we need to intervene. How we intervene should always be in the least disruptive and intense way,” she said.
These measures could include examining sleep hygiene, adjusting medications, or introducing exercise.
“But there really does come a time for some people where cognitive remediation is going to be helpful, so it should be more available,” Dr. Medalia said.
Although increased availability is partially dependent on having enough trained therapists, the main reason CR is not more widely available is because “people just don’t think about cognition and they don’t know how to talk about it,” she noted. In addition, she said, even when it is available, clinicians don’t refer patients.
“That tells you something. The solution here is not to put a cognitive remediation program everywhere but ... to get people comfortable talking about cognition and identifying when an intervention is needed,” said Dr. Medalia.
One study author received grants from the National Institute for Health Research during the conduct of the study and is the creator of CIRCuiTs, a cognitive remediation software program. The other investigators and Dr. Medalia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Cognitive remediation (CR), a therapy that encompasses nonpharmacologic approaches to improving cognitive function for patients with severe mental illness, may lead to significant improvement for patients with schizophrenia, new research suggests.
A systematic review of 130 worldwide studies that included almost 9,000 participants showed that CR significantly improved global cognition and global functioning. In addition, investigators identified key patient characteristics that flagged ideal candidates for the therapy.
“Because pharmacological treatment exerts limited effects on cognitive deficits, and clinical remission does not necessarily result in functional recovery, widespread implementation of CR could be a game-changer for achieving the patient’s personal recovery goals,” the researchers wrote.
“We hope that this systematic review could help clinicians understand how to make CR even more effective and even more personalized,” lead author Antonio Vita, MD, PhD, department of clinical and experimental sciences, University of Brescia, Italy, said in an interview.
Dr. Vita noted that he would also encourage clinicians to consider “proposing it for clinical practice.”
The findings were presented at the virtual congress of the Schizophrenia International Research Society (SIRS 2021) and were published simultaneously in JAMA Psychiatry.
Resistance continues
Cognition “should be a focus of treatment because most of the disability and functional consequences of the disease are related to ... neurocognitive impairment and impairment of social cognition,” Dr. Vita said.
He noted that treatments that focus on cognition are crucial for the recovery of patients with schizophrenia.
However, despite a “solid body of evidence” supporting the efficacy of CR and guideline recommendations that CR be included in psychiatric services, reluctance remains, the investigators noted.
The study’s goal was to determine optimal candidates for CR and to assess outcomes of the therapy and its four core elements:
- The presence of an active and trained therapist.
- Repeated practice of cognitive exercises.
- Structured development of cognitive strategies.
- Techniques to improve the transfer of cognitive gains to the real world, such as integrated psychosocial rehabilitation.
The investigators conducted a systematic literature search of the PubMed, Scopus, and PsychInfo databases to find relevant studies of CR published between January 2011 and February 2020. They also “hand-searched” meta-analyses, reviews, and reference lists.
Ultimately, the analysis included 130 randomized clinical trials comparing CR with a control condition in 8,851 patients with schizophrenia spectrum disorders.
Of these studies, 57 were conducted in Europe, 38 in the United States, 22 in Asia, 4 in Canada, 4 in Middle Eastern countries, 3 in Australia, and 2 in Brazil.
The mean age of the participants was 36.7 years, and 68% were men. The average age at the time of schizophrenia onset was 23.3 years, and the mean duration of illness was 13.8 years.
The average duration of CR treatment was 15.2 weeks. The four elements were well represented; each was offered to at least 71% of patients.
The comparator therapy was treatment as usual (TAU), in 34.3% of cases, or active TAU with multidisciplinary rehabilitation, in 15.2% of cases. The remaining interventions were either nonspecific (30.8%) or were devised specifically for the study (19.9%).
Results showed that CR had a significant, albeit moderate, effect on global cognition (Cohen’s d effect size, 0.29; P < .001) and global functioning (effect size, 0.22; P < .01).
Having an active and trained therapist had a significant impact on cognition and functioning (P = .04 for both), as did the structured development of cognitive strategies (P = .002 for cognition; P = .004 for functioning).
The integration of psychosocial rehabilitation also had a significant effect on functioning (P = .003).
Interventions that included all of the core elements had a “highly significant” association with global cognition (P = .02) and global functioning (P < .001), the investigators reported. Longer treatments were significantly associated with greater functional improvement (P = .006).
The investigators found that improvements were greater among patients who had fewer years of education (P = .03 for cognition; P = .02 for functioning), lower premorbid IQ scores (P = .04 for functioning), and more severe symptoms at baseline (P = .005 for cognition).
The researchers noted that CR should become more widely available because it has the “potential to be an element of standard care rather than an optional intervention targeting selected individuals.”
An overlooked treatment option
Commenting on the findings for this news organization, Alice Medalia, PhD, director of the Lieber Recovery Clinic at Columbia University Irving Medical Center, New York, noted that this study is the second large-scale analysis of the use of CR for patients with schizophrenia to come out this year. The other was published in Schizophrenia Bulletin.
“So this is a banner year for large reviews,” she said. “It’s great to have two studies like this [that] tell a very consistent story.”
Dr. Medalia, who was not involved with the research, said individuals “don’t really talk about cognition very much.”
CR, she added, is “one of an array of services that one should be providing, and the bigger picture is that every single person should have their cognitive health needs addressed.
“If someone is having problems, and it’s getting in the way of them being the kind of person they want to be and doing want they want to do, we need to intervene. How we intervene should always be in the least disruptive and intense way,” she said.
These measures could include examining sleep hygiene, adjusting medications, or introducing exercise.
“But there really does come a time for some people where cognitive remediation is going to be helpful, so it should be more available,” Dr. Medalia said.
Although increased availability is partially dependent on having enough trained therapists, the main reason CR is not more widely available is because “people just don’t think about cognition and they don’t know how to talk about it,” she noted. In addition, she said, even when it is available, clinicians don’t refer patients.
“That tells you something. The solution here is not to put a cognitive remediation program everywhere but ... to get people comfortable talking about cognition and identifying when an intervention is needed,” said Dr. Medalia.
One study author received grants from the National Institute for Health Research during the conduct of the study and is the creator of CIRCuiTs, a cognitive remediation software program. The other investigators and Dr. Medalia have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID lockdowns linked to PTSD in patients with eating disorders
COVID-19 and its resulting lockdowns are linked to posttraumatic stress disorder symptoms and other adverse outcomes among patients with eating disorders (EDs), two new studies show.
Results of the first study show that patients with EDs had more stress, anxiety, depression, and PTSD-related symptoms during the lockdowns than their mentally healthy peers.
In the second study, treatment-related symptom improvement among patients with bulimia nervosa (BN) slowed following lockdown. In addition, patients with BN or anorexia nervosa (AN) experienced significant worsening of disorder-specific behaviors, including binge eating and overexercising.
Because of the strict lockdown measures introduced by the Italian government to contain the COVID-19 pandemic, “everyday life of all citizens was disrupted,” Veronica Nisticò, MS, Università Degli Studi Di Milano, who led the first study, told delegates attending the virtual European Psychiatric Association 2021 Congress.
In addition to difficulties in accessing health care, “it became difficult to go to the supermarket, to the gym, and to have the social support we were all used to,” all of which had a well-documented impact on mental health, added Ms. Nisticò, who is also affiliated with Aldo Ravelli Research Center for Neurotechnology and Experimental Brain Therapeutics.
Loss of control
Previous research suggests that individuals with EDs experience high levels of anxiety and an increase in binge eating, exercise, and purging behaviors, said Ms. Nisticò.
To investigate further, the researchers conducted a longitudinal study of the changes in prevalence of adverse outcomes. In the study, two assessments were conducted.
The second group served as the control group.
Participants completed an online survey that included several standardized depression and anxiety scales, as well as an ad hoc survey adapted from the Eating Disorder Examination Questionnaire. This assessed changes in restrictive dieting, control over food, body image, and psychological well-being in comparison with prepandemic levels.
The results, which were also recently published online in Eating and Weight Disorders – Studies on Anorexia, Bulimia and Obesity, showed that patients with EDs experienced significantly more stress, anxiety, depression, and PTSD-related symptoms in comparison with control persons (P < .05 for all).
In addition, the investigators found that those with EDs were more fearful of losing control over their eating behavior, spent more time thinking about food and their body, and became more uncomfortable seeing their body than before the lockdown in comparison with those without EDs (P < .05).
Clinical implications
A second assessment, which occurred in June 2020, after lockdown restrictions were lifted, included 40 patients with EDs who had taken part in the first assessment. This time, participants were asked to compare their current eating behavior with their eating behavior during the lockdown.
Although the lifting of lockdown restrictions was associated with significant improvement in PTSD-related symptoms, the impact on stress, anxiety, and depression persisted.
These findings, said Ms. Nisticó, support the hypothesis that specific conditions that occurred during the lockdown had a direct effect on specific ED symptoms.
These findings, she added, should be considered when developing interventions for EDs in the context of individual psychotherapy and when designing large, preventive interventions.
In the second study, Eleonora Rossi, MD, psychiatric unit, department of health sciences, University of Florence (Italy), and colleagues examined the longitudinal impact of the pandemic on individuals with EDs.
They examined 74 patients with AN or BN who had undergone baseline assessments and had completed a number of questionnaires in the first months of 2019 in conjunction with being enrolled in another study.
Participants were treated with enhanced cognitive-behavioral therapy and were reevaluated between November 2019 and January 2020. They were then compared with 97 healthy individuals.
Bulimia patients more vulnerable
After the outbreak of the pandemic, most treatment was administered online, so patients were able to continue therapy, Dr. Rossi said during her presentation.
All participants were assessed again in April 2020, 6 weeks after the start of Italy’s lockdown.
The results, which were published in the International Journal of Eating Disorders, show that the patients with EDs “underwent a significant improvement in terms of general and eating disorder specific psychopathology” during the first treatment period, Dr. Rossi reported. In addition, among those with AN, body mass index increased significantly (P < .05 for all).
Patients with AN continued to improve during the lockdown when therapy was administered online. However, improvements that had occurred among those with BN slowed, Dr. Rossi noted.
In addition, both groups of patients with EDs experienced a worsening of their pathological eating behaviors during the lockdown, in particular, objective binge eating and compensatory physical exercise (P < .05).
“Indeed, the positive trajectory of improvement observed before lockdown was clearly interrupted during the pandemic period,” Dr. Rossi said. This could “represent a possible hint of an imminent exacerbation of the disease.”
The results also suggest that the occurrence of arguments within the household and fear regarding the safety of loved ones predicted an increase in symptoms during the lockdown, she added.
In addition, patients with BN reported more severe COVID-related PTSD symptoms than did those with AN and the control group. This increase in severity of symptoms was more prevalent among patients who had a history of childhood trauma and among those with insecure attachment, suggesting that such patients may be more vulnerable.
Evidence of recovery
Commenting on the studies, David Spiegel, MD, associate chair of psychiatry, Stanford (Calif.) University, noted that EDs commonly occur after physical or sexual trauma earlier in life.
“It’s a standard thing with trauma-related disorders that any other, even relatively minor, traumatic experience can exacerbate PTSD symptoms,” said Dr. Spiegel, who was not involved in the studies. In addition, the trauma of the COVID pandemic “was not minor.
“The relative isolation and the lack of outside contact may focus many people with eating disorders even more on their struggles with how they are taking care of their bodies,” said Dr. Spiegel.
“It struck me that the anorexia nervosa group were more impervious than the bulimia nervosa group, but I think that’s the case with the disorder. In some ways it’s more severe, obviously a more life-threatening disorder,” he added.
The “hopeful thing is that there seemed to be some evidence of recovery and improvement, particularly with the posttraumatic stress exacerbation, as time went on,” Dr. Spiegel said, “and that’s a good thing.”
The study authors and Dr. Spiegel reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID-19 and its resulting lockdowns are linked to posttraumatic stress disorder symptoms and other adverse outcomes among patients with eating disorders (EDs), two new studies show.
Results of the first study show that patients with EDs had more stress, anxiety, depression, and PTSD-related symptoms during the lockdowns than their mentally healthy peers.
In the second study, treatment-related symptom improvement among patients with bulimia nervosa (BN) slowed following lockdown. In addition, patients with BN or anorexia nervosa (AN) experienced significant worsening of disorder-specific behaviors, including binge eating and overexercising.
Because of the strict lockdown measures introduced by the Italian government to contain the COVID-19 pandemic, “everyday life of all citizens was disrupted,” Veronica Nisticò, MS, Università Degli Studi Di Milano, who led the first study, told delegates attending the virtual European Psychiatric Association 2021 Congress.
In addition to difficulties in accessing health care, “it became difficult to go to the supermarket, to the gym, and to have the social support we were all used to,” all of which had a well-documented impact on mental health, added Ms. Nisticò, who is also affiliated with Aldo Ravelli Research Center for Neurotechnology and Experimental Brain Therapeutics.
Loss of control
Previous research suggests that individuals with EDs experience high levels of anxiety and an increase in binge eating, exercise, and purging behaviors, said Ms. Nisticò.
To investigate further, the researchers conducted a longitudinal study of the changes in prevalence of adverse outcomes. In the study, two assessments were conducted.
The second group served as the control group.
Participants completed an online survey that included several standardized depression and anxiety scales, as well as an ad hoc survey adapted from the Eating Disorder Examination Questionnaire. This assessed changes in restrictive dieting, control over food, body image, and psychological well-being in comparison with prepandemic levels.
The results, which were also recently published online in Eating and Weight Disorders – Studies on Anorexia, Bulimia and Obesity, showed that patients with EDs experienced significantly more stress, anxiety, depression, and PTSD-related symptoms in comparison with control persons (P < .05 for all).
In addition, the investigators found that those with EDs were more fearful of losing control over their eating behavior, spent more time thinking about food and their body, and became more uncomfortable seeing their body than before the lockdown in comparison with those without EDs (P < .05).
Clinical implications
A second assessment, which occurred in June 2020, after lockdown restrictions were lifted, included 40 patients with EDs who had taken part in the first assessment. This time, participants were asked to compare their current eating behavior with their eating behavior during the lockdown.
Although the lifting of lockdown restrictions was associated with significant improvement in PTSD-related symptoms, the impact on stress, anxiety, and depression persisted.
These findings, said Ms. Nisticó, support the hypothesis that specific conditions that occurred during the lockdown had a direct effect on specific ED symptoms.
These findings, she added, should be considered when developing interventions for EDs in the context of individual psychotherapy and when designing large, preventive interventions.
In the second study, Eleonora Rossi, MD, psychiatric unit, department of health sciences, University of Florence (Italy), and colleagues examined the longitudinal impact of the pandemic on individuals with EDs.
They examined 74 patients with AN or BN who had undergone baseline assessments and had completed a number of questionnaires in the first months of 2019 in conjunction with being enrolled in another study.
Participants were treated with enhanced cognitive-behavioral therapy and were reevaluated between November 2019 and January 2020. They were then compared with 97 healthy individuals.
Bulimia patients more vulnerable
After the outbreak of the pandemic, most treatment was administered online, so patients were able to continue therapy, Dr. Rossi said during her presentation.
All participants were assessed again in April 2020, 6 weeks after the start of Italy’s lockdown.
The results, which were published in the International Journal of Eating Disorders, show that the patients with EDs “underwent a significant improvement in terms of general and eating disorder specific psychopathology” during the first treatment period, Dr. Rossi reported. In addition, among those with AN, body mass index increased significantly (P < .05 for all).
Patients with AN continued to improve during the lockdown when therapy was administered online. However, improvements that had occurred among those with BN slowed, Dr. Rossi noted.
In addition, both groups of patients with EDs experienced a worsening of their pathological eating behaviors during the lockdown, in particular, objective binge eating and compensatory physical exercise (P < .05).
“Indeed, the positive trajectory of improvement observed before lockdown was clearly interrupted during the pandemic period,” Dr. Rossi said. This could “represent a possible hint of an imminent exacerbation of the disease.”
The results also suggest that the occurrence of arguments within the household and fear regarding the safety of loved ones predicted an increase in symptoms during the lockdown, she added.
In addition, patients with BN reported more severe COVID-related PTSD symptoms than did those with AN and the control group. This increase in severity of symptoms was more prevalent among patients who had a history of childhood trauma and among those with insecure attachment, suggesting that such patients may be more vulnerable.
Evidence of recovery
Commenting on the studies, David Spiegel, MD, associate chair of psychiatry, Stanford (Calif.) University, noted that EDs commonly occur after physical or sexual trauma earlier in life.
“It’s a standard thing with trauma-related disorders that any other, even relatively minor, traumatic experience can exacerbate PTSD symptoms,” said Dr. Spiegel, who was not involved in the studies. In addition, the trauma of the COVID pandemic “was not minor.
“The relative isolation and the lack of outside contact may focus many people with eating disorders even more on their struggles with how they are taking care of their bodies,” said Dr. Spiegel.
“It struck me that the anorexia nervosa group were more impervious than the bulimia nervosa group, but I think that’s the case with the disorder. In some ways it’s more severe, obviously a more life-threatening disorder,” he added.
The “hopeful thing is that there seemed to be some evidence of recovery and improvement, particularly with the posttraumatic stress exacerbation, as time went on,” Dr. Spiegel said, “and that’s a good thing.”
The study authors and Dr. Spiegel reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID-19 and its resulting lockdowns are linked to posttraumatic stress disorder symptoms and other adverse outcomes among patients with eating disorders (EDs), two new studies show.
Results of the first study show that patients with EDs had more stress, anxiety, depression, and PTSD-related symptoms during the lockdowns than their mentally healthy peers.
In the second study, treatment-related symptom improvement among patients with bulimia nervosa (BN) slowed following lockdown. In addition, patients with BN or anorexia nervosa (AN) experienced significant worsening of disorder-specific behaviors, including binge eating and overexercising.
Because of the strict lockdown measures introduced by the Italian government to contain the COVID-19 pandemic, “everyday life of all citizens was disrupted,” Veronica Nisticò, MS, Università Degli Studi Di Milano, who led the first study, told delegates attending the virtual European Psychiatric Association 2021 Congress.
In addition to difficulties in accessing health care, “it became difficult to go to the supermarket, to the gym, and to have the social support we were all used to,” all of which had a well-documented impact on mental health, added Ms. Nisticò, who is also affiliated with Aldo Ravelli Research Center for Neurotechnology and Experimental Brain Therapeutics.
Loss of control
Previous research suggests that individuals with EDs experience high levels of anxiety and an increase in binge eating, exercise, and purging behaviors, said Ms. Nisticò.
To investigate further, the researchers conducted a longitudinal study of the changes in prevalence of adverse outcomes. In the study, two assessments were conducted.
The second group served as the control group.
Participants completed an online survey that included several standardized depression and anxiety scales, as well as an ad hoc survey adapted from the Eating Disorder Examination Questionnaire. This assessed changes in restrictive dieting, control over food, body image, and psychological well-being in comparison with prepandemic levels.
The results, which were also recently published online in Eating and Weight Disorders – Studies on Anorexia, Bulimia and Obesity, showed that patients with EDs experienced significantly more stress, anxiety, depression, and PTSD-related symptoms in comparison with control persons (P < .05 for all).
In addition, the investigators found that those with EDs were more fearful of losing control over their eating behavior, spent more time thinking about food and their body, and became more uncomfortable seeing their body than before the lockdown in comparison with those without EDs (P < .05).
Clinical implications
A second assessment, which occurred in June 2020, after lockdown restrictions were lifted, included 40 patients with EDs who had taken part in the first assessment. This time, participants were asked to compare their current eating behavior with their eating behavior during the lockdown.
Although the lifting of lockdown restrictions was associated with significant improvement in PTSD-related symptoms, the impact on stress, anxiety, and depression persisted.
These findings, said Ms. Nisticó, support the hypothesis that specific conditions that occurred during the lockdown had a direct effect on specific ED symptoms.
These findings, she added, should be considered when developing interventions for EDs in the context of individual psychotherapy and when designing large, preventive interventions.
In the second study, Eleonora Rossi, MD, psychiatric unit, department of health sciences, University of Florence (Italy), and colleagues examined the longitudinal impact of the pandemic on individuals with EDs.
They examined 74 patients with AN or BN who had undergone baseline assessments and had completed a number of questionnaires in the first months of 2019 in conjunction with being enrolled in another study.
Participants were treated with enhanced cognitive-behavioral therapy and were reevaluated between November 2019 and January 2020. They were then compared with 97 healthy individuals.
Bulimia patients more vulnerable
After the outbreak of the pandemic, most treatment was administered online, so patients were able to continue therapy, Dr. Rossi said during her presentation.
All participants were assessed again in April 2020, 6 weeks after the start of Italy’s lockdown.
The results, which were published in the International Journal of Eating Disorders, show that the patients with EDs “underwent a significant improvement in terms of general and eating disorder specific psychopathology” during the first treatment period, Dr. Rossi reported. In addition, among those with AN, body mass index increased significantly (P < .05 for all).
Patients with AN continued to improve during the lockdown when therapy was administered online. However, improvements that had occurred among those with BN slowed, Dr. Rossi noted.
In addition, both groups of patients with EDs experienced a worsening of their pathological eating behaviors during the lockdown, in particular, objective binge eating and compensatory physical exercise (P < .05).
“Indeed, the positive trajectory of improvement observed before lockdown was clearly interrupted during the pandemic period,” Dr. Rossi said. This could “represent a possible hint of an imminent exacerbation of the disease.”
The results also suggest that the occurrence of arguments within the household and fear regarding the safety of loved ones predicted an increase in symptoms during the lockdown, she added.
In addition, patients with BN reported more severe COVID-related PTSD symptoms than did those with AN and the control group. This increase in severity of symptoms was more prevalent among patients who had a history of childhood trauma and among those with insecure attachment, suggesting that such patients may be more vulnerable.
Evidence of recovery
Commenting on the studies, David Spiegel, MD, associate chair of psychiatry, Stanford (Calif.) University, noted that EDs commonly occur after physical or sexual trauma earlier in life.
“It’s a standard thing with trauma-related disorders that any other, even relatively minor, traumatic experience can exacerbate PTSD symptoms,” said Dr. Spiegel, who was not involved in the studies. In addition, the trauma of the COVID pandemic “was not minor.
“The relative isolation and the lack of outside contact may focus many people with eating disorders even more on their struggles with how they are taking care of their bodies,” said Dr. Spiegel.
“It struck me that the anorexia nervosa group were more impervious than the bulimia nervosa group, but I think that’s the case with the disorder. In some ways it’s more severe, obviously a more life-threatening disorder,” he added.
The “hopeful thing is that there seemed to be some evidence of recovery and improvement, particularly with the posttraumatic stress exacerbation, as time went on,” Dr. Spiegel said, “and that’s a good thing.”
The study authors and Dr. Spiegel reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Potential first-in-class schizophrenia drug cuts negative symptoms
The novel antipsychotic agent SEP-363856 (Sunovion Pharmaceuticals) has a significant and ongoing effect on negative symptoms in patients with schizophrenia, new research shows.
Results of a phase 2, placebo-controlled trial show SEP-363856 significantly decreased total scores on the Brief Negative Symptom Scale (BNSS), and lowered subscale scores for such symptoms as alogia and asociality, compared with placebo.
The active-treatment group also showed significantly lower scores on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). During an open-label extension of the study, both BNSS total scores and PANSS negative symptom scores continued to decrease.
Overall, the results “provide further confirmation of the effectiveness of SEP-363856 in treating schizophrenia,” study investigator Kenneth Koblan, PhD, of Sunovion said in an interview.
He added that the compound also showed “a favorable safety and tolerability profile that is differentiated from first and second generation antipsychotics, and which is consistent with the absence of D2-receptor binding.”
The findings were presented at the 2021 annual congress of the Schizophrenia International Research Society.
FDA breakthrough designation
SEP-363856 has a completely different mechanism of action from currently available antipsychotics.
In May 2019, it was granted breakthrough therapy designation by the Food and Drug Administration as a novel treatment for patients with schizophrenia.
Phase 2 data published in the New England Journal of Medicine in 2020 showed it achieved significant and clinically meaningful improvements in PANSS total scores after 4 weeks in patients hospitalized with an acute exacerbation of schizophrenia. It also showed durable effects out to 26 weeks.
In the current analysis, the investigators focused on negative symptoms, both in the initial acute treatment phase and an open-label extension.
They analyzed data from the previous phase 2 trial using a validated Uncorrelated PANSS Score Matrix (UPSM) transformation of the PANSS to isolate the effects of the drug on apathy/avolition and deficit of expression. They also used the BNSS.
Patients aged 18-40 years with an acute exacerbation of schizophrenia were randomly assigned to receive either 50 mg or 75 mg of SEP-363856 per day (n = 120) or matching placebo (n = 125) for 4 weeks. Completers were eligible for enrollment in a 26-week phase 2 extension study of 25 mg, 50 mg, or 75 mg of SEP-363856 per day.
The mean age of the participants was 30 years, and 64% were men. The treatment groups were balanced in terms of demographics.
Significant improvement
The BNSS total score decreased significantly with SEP-363856 over placebo during the 4-week acute treatment period, at a mean reduction of 7.1 versus 2.7, or an effect size of 0.48 (P < .001).
Scores on the PANSS negative subscale also decreased significantly with the active drugs, with an effect size of 0.37 versus placebo (P < .05), as did scores on the UPSM apathy/avolition and deficit of expression subscales (effect size, 0.32; P < .05 for both).
In addition, there were significant reductions with SEP-363856 over placebo for the BNSS alogia, asociality, anhedonia, avolition, and blunted-affect subscales (P < .05 for all comparisons) but not for the distress subscale.
During the open-label extension, mean BNSS total scores continued to decrease for the SEP-363856 group, at an average reduction versus extension enrollment across the whole cohort of 11.3.
PANSS negative symptom scores also decreased by an average of 5.2 points, while UPSM apathy/volition scores decreased by 0.4 points on average. UPSM deficit expression scores decreased by 0.5 points.
When the researchers restricted the analysis to those who received SEP-363856 during the acute treatment phase and then continued using the drug during the open-label extension, they found BNSS total scores decreased by an additional 8 points.
Similarly, PANSS negative symptom scores decreased during the open-label extension by an average of 4 points. For UPSM apathy/avolition and deficit of expression, the additional decrease was 0.3 points on average.
In addition, an analysis of the drug’s safety and tolerability showed that, compared with the commonly prescribed antipsychotic lurasidone, it had a significantly lower risk of adverse effects. In addition, the drug was not associated with extrapyramidal symptoms and had no adverse cardiometabolic effects, Dr. Koblan reported.
Still in development
Commenting on the findings, René S. Kahn, MD, PhD, chair of the department of psychiatry, Icahn School of Medicine at Mount Sinai, New York, noted that, although the results showed that the drug had a “nice effect” on negative symptoms, it’s still in development.
Dr. Kahn, who was not involved in the research, said “we’ve all seen” drugs that were extremely promising in phase 2 trials that have then failed in phase 3 trials. he added.
“Obviously I hope it’s going to work out, because we are in desperate need of new drugs, especially with a new mechanism of action and not ‘me too’ drugs. And this definitely not a ‘me too’ drug,” Dr. Kahn said. However, “we’ll have to wait.”
He noted that psychosis is often the primary focus of schizophrenia management. However, he added, cognitive and negative symptoms are also “very relevant” to the disorder.
“In fact, both of them may be more important in determining the long-term outcome of schizophrenia than psychosis, [and] most of the antipsychotics that we currently have are not very effective against negative symptoms,” he said.
“So it would really be a breakthrough if we have a drug that is really effective not only against positive psychotic symptoms, but also against negative and possibly cognitive, symptoms,” Dr. Kahn added.
Commenting on the drug’s safety, Dr. Kahn said there is a need for head-to-head studies of active drugs before any firm conclusions can be drawn.
However, he noted the exploratory analysis suggests it has a different side effect profile, compared with other medications on the market.
The study was supported by Sunovion Pharmaceuticals. Dr. Koblan and his coinvestigators are employees of Sunovion.
A version of this article first appeared on Medscape.com.
The novel antipsychotic agent SEP-363856 (Sunovion Pharmaceuticals) has a significant and ongoing effect on negative symptoms in patients with schizophrenia, new research shows.
Results of a phase 2, placebo-controlled trial show SEP-363856 significantly decreased total scores on the Brief Negative Symptom Scale (BNSS), and lowered subscale scores for such symptoms as alogia and asociality, compared with placebo.
The active-treatment group also showed significantly lower scores on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). During an open-label extension of the study, both BNSS total scores and PANSS negative symptom scores continued to decrease.
Overall, the results “provide further confirmation of the effectiveness of SEP-363856 in treating schizophrenia,” study investigator Kenneth Koblan, PhD, of Sunovion said in an interview.
He added that the compound also showed “a favorable safety and tolerability profile that is differentiated from first and second generation antipsychotics, and which is consistent with the absence of D2-receptor binding.”
The findings were presented at the 2021 annual congress of the Schizophrenia International Research Society.
FDA breakthrough designation
SEP-363856 has a completely different mechanism of action from currently available antipsychotics.
In May 2019, it was granted breakthrough therapy designation by the Food and Drug Administration as a novel treatment for patients with schizophrenia.
Phase 2 data published in the New England Journal of Medicine in 2020 showed it achieved significant and clinically meaningful improvements in PANSS total scores after 4 weeks in patients hospitalized with an acute exacerbation of schizophrenia. It also showed durable effects out to 26 weeks.
In the current analysis, the investigators focused on negative symptoms, both in the initial acute treatment phase and an open-label extension.
They analyzed data from the previous phase 2 trial using a validated Uncorrelated PANSS Score Matrix (UPSM) transformation of the PANSS to isolate the effects of the drug on apathy/avolition and deficit of expression. They also used the BNSS.
Patients aged 18-40 years with an acute exacerbation of schizophrenia were randomly assigned to receive either 50 mg or 75 mg of SEP-363856 per day (n = 120) or matching placebo (n = 125) for 4 weeks. Completers were eligible for enrollment in a 26-week phase 2 extension study of 25 mg, 50 mg, or 75 mg of SEP-363856 per day.
The mean age of the participants was 30 years, and 64% were men. The treatment groups were balanced in terms of demographics.
Significant improvement
The BNSS total score decreased significantly with SEP-363856 over placebo during the 4-week acute treatment period, at a mean reduction of 7.1 versus 2.7, or an effect size of 0.48 (P < .001).
Scores on the PANSS negative subscale also decreased significantly with the active drugs, with an effect size of 0.37 versus placebo (P < .05), as did scores on the UPSM apathy/avolition and deficit of expression subscales (effect size, 0.32; P < .05 for both).
In addition, there were significant reductions with SEP-363856 over placebo for the BNSS alogia, asociality, anhedonia, avolition, and blunted-affect subscales (P < .05 for all comparisons) but not for the distress subscale.
During the open-label extension, mean BNSS total scores continued to decrease for the SEP-363856 group, at an average reduction versus extension enrollment across the whole cohort of 11.3.
PANSS negative symptom scores also decreased by an average of 5.2 points, while UPSM apathy/volition scores decreased by 0.4 points on average. UPSM deficit expression scores decreased by 0.5 points.
When the researchers restricted the analysis to those who received SEP-363856 during the acute treatment phase and then continued using the drug during the open-label extension, they found BNSS total scores decreased by an additional 8 points.
Similarly, PANSS negative symptom scores decreased during the open-label extension by an average of 4 points. For UPSM apathy/avolition and deficit of expression, the additional decrease was 0.3 points on average.
In addition, an analysis of the drug’s safety and tolerability showed that, compared with the commonly prescribed antipsychotic lurasidone, it had a significantly lower risk of adverse effects. In addition, the drug was not associated with extrapyramidal symptoms and had no adverse cardiometabolic effects, Dr. Koblan reported.
Still in development
Commenting on the findings, René S. Kahn, MD, PhD, chair of the department of psychiatry, Icahn School of Medicine at Mount Sinai, New York, noted that, although the results showed that the drug had a “nice effect” on negative symptoms, it’s still in development.
Dr. Kahn, who was not involved in the research, said “we’ve all seen” drugs that were extremely promising in phase 2 trials that have then failed in phase 3 trials. he added.
“Obviously I hope it’s going to work out, because we are in desperate need of new drugs, especially with a new mechanism of action and not ‘me too’ drugs. And this definitely not a ‘me too’ drug,” Dr. Kahn said. However, “we’ll have to wait.”
He noted that psychosis is often the primary focus of schizophrenia management. However, he added, cognitive and negative symptoms are also “very relevant” to the disorder.
“In fact, both of them may be more important in determining the long-term outcome of schizophrenia than psychosis, [and] most of the antipsychotics that we currently have are not very effective against negative symptoms,” he said.
“So it would really be a breakthrough if we have a drug that is really effective not only against positive psychotic symptoms, but also against negative and possibly cognitive, symptoms,” Dr. Kahn added.
Commenting on the drug’s safety, Dr. Kahn said there is a need for head-to-head studies of active drugs before any firm conclusions can be drawn.
However, he noted the exploratory analysis suggests it has a different side effect profile, compared with other medications on the market.
The study was supported by Sunovion Pharmaceuticals. Dr. Koblan and his coinvestigators are employees of Sunovion.
A version of this article first appeared on Medscape.com.
The novel antipsychotic agent SEP-363856 (Sunovion Pharmaceuticals) has a significant and ongoing effect on negative symptoms in patients with schizophrenia, new research shows.
Results of a phase 2, placebo-controlled trial show SEP-363856 significantly decreased total scores on the Brief Negative Symptom Scale (BNSS), and lowered subscale scores for such symptoms as alogia and asociality, compared with placebo.
The active-treatment group also showed significantly lower scores on the negative subscale of the Positive and Negative Syndrome Scale (PANSS). During an open-label extension of the study, both BNSS total scores and PANSS negative symptom scores continued to decrease.
Overall, the results “provide further confirmation of the effectiveness of SEP-363856 in treating schizophrenia,” study investigator Kenneth Koblan, PhD, of Sunovion said in an interview.
He added that the compound also showed “a favorable safety and tolerability profile that is differentiated from first and second generation antipsychotics, and which is consistent with the absence of D2-receptor binding.”
The findings were presented at the 2021 annual congress of the Schizophrenia International Research Society.
FDA breakthrough designation
SEP-363856 has a completely different mechanism of action from currently available antipsychotics.
In May 2019, it was granted breakthrough therapy designation by the Food and Drug Administration as a novel treatment for patients with schizophrenia.
Phase 2 data published in the New England Journal of Medicine in 2020 showed it achieved significant and clinically meaningful improvements in PANSS total scores after 4 weeks in patients hospitalized with an acute exacerbation of schizophrenia. It also showed durable effects out to 26 weeks.
In the current analysis, the investigators focused on negative symptoms, both in the initial acute treatment phase and an open-label extension.
They analyzed data from the previous phase 2 trial using a validated Uncorrelated PANSS Score Matrix (UPSM) transformation of the PANSS to isolate the effects of the drug on apathy/avolition and deficit of expression. They also used the BNSS.
Patients aged 18-40 years with an acute exacerbation of schizophrenia were randomly assigned to receive either 50 mg or 75 mg of SEP-363856 per day (n = 120) or matching placebo (n = 125) for 4 weeks. Completers were eligible for enrollment in a 26-week phase 2 extension study of 25 mg, 50 mg, or 75 mg of SEP-363856 per day.
The mean age of the participants was 30 years, and 64% were men. The treatment groups were balanced in terms of demographics.
Significant improvement
The BNSS total score decreased significantly with SEP-363856 over placebo during the 4-week acute treatment period, at a mean reduction of 7.1 versus 2.7, or an effect size of 0.48 (P < .001).
Scores on the PANSS negative subscale also decreased significantly with the active drugs, with an effect size of 0.37 versus placebo (P < .05), as did scores on the UPSM apathy/avolition and deficit of expression subscales (effect size, 0.32; P < .05 for both).
In addition, there were significant reductions with SEP-363856 over placebo for the BNSS alogia, asociality, anhedonia, avolition, and blunted-affect subscales (P < .05 for all comparisons) but not for the distress subscale.
During the open-label extension, mean BNSS total scores continued to decrease for the SEP-363856 group, at an average reduction versus extension enrollment across the whole cohort of 11.3.
PANSS negative symptom scores also decreased by an average of 5.2 points, while UPSM apathy/volition scores decreased by 0.4 points on average. UPSM deficit expression scores decreased by 0.5 points.
When the researchers restricted the analysis to those who received SEP-363856 during the acute treatment phase and then continued using the drug during the open-label extension, they found BNSS total scores decreased by an additional 8 points.
Similarly, PANSS negative symptom scores decreased during the open-label extension by an average of 4 points. For UPSM apathy/avolition and deficit of expression, the additional decrease was 0.3 points on average.
In addition, an analysis of the drug’s safety and tolerability showed that, compared with the commonly prescribed antipsychotic lurasidone, it had a significantly lower risk of adverse effects. In addition, the drug was not associated with extrapyramidal symptoms and had no adverse cardiometabolic effects, Dr. Koblan reported.
Still in development
Commenting on the findings, René S. Kahn, MD, PhD, chair of the department of psychiatry, Icahn School of Medicine at Mount Sinai, New York, noted that, although the results showed that the drug had a “nice effect” on negative symptoms, it’s still in development.
Dr. Kahn, who was not involved in the research, said “we’ve all seen” drugs that were extremely promising in phase 2 trials that have then failed in phase 3 trials. he added.
“Obviously I hope it’s going to work out, because we are in desperate need of new drugs, especially with a new mechanism of action and not ‘me too’ drugs. And this definitely not a ‘me too’ drug,” Dr. Kahn said. However, “we’ll have to wait.”
He noted that psychosis is often the primary focus of schizophrenia management. However, he added, cognitive and negative symptoms are also “very relevant” to the disorder.
“In fact, both of them may be more important in determining the long-term outcome of schizophrenia than psychosis, [and] most of the antipsychotics that we currently have are not very effective against negative symptoms,” he said.
“So it would really be a breakthrough if we have a drug that is really effective not only against positive psychotic symptoms, but also against negative and possibly cognitive, symptoms,” Dr. Kahn added.
Commenting on the drug’s safety, Dr. Kahn said there is a need for head-to-head studies of active drugs before any firm conclusions can be drawn.
However, he noted the exploratory analysis suggests it has a different side effect profile, compared with other medications on the market.
The study was supported by Sunovion Pharmaceuticals. Dr. Koblan and his coinvestigators are employees of Sunovion.
A version of this article first appeared on Medscape.com.
Adjunctive MDMA safe, effective for severe PTSD
Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.
MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.
MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
Growing interest
, particularly because failure rates with most available evidence-based treatments have been relatively high.
As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.
The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.
In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.
Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.
The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.
Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
‘Dramatic improvement’
Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.
The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.
Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.
“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”
Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”
In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
Carefully controlled
Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.
In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.
Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.
There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.
The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.
“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”
However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
‘On the right track’
Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”
“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.
He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”
The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.
The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.
MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.
MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
Growing interest
, particularly because failure rates with most available evidence-based treatments have been relatively high.
As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.
The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.
In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.
Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.
The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.
Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
‘Dramatic improvement’
Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.
The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.
Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.
“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”
Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”
In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
Carefully controlled
Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.
In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.
Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.
There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.
The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.
“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”
However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
‘On the right track’
Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”
“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.
He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”
The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.
The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Adding 3,4-methylenedioxymethamphetamine (MDMA) to integrative psychotherapy may significantly improve symptoms and well-being for patients with severe posttraumatic stress disorder, including those with the dissociative subtype, new research suggests.
MAPP1 is the first phase 3 randomized controlled trial of MDMA-assisted therapy in this population. Participants who received the active treatment showed greater improvement in PTSD symptoms, mood, and empathy in comparison with participants who received placebo.
MDMA was “extremely effective, particularly for a subpopulation that ordinarily does not respond well to conventional treatment,” study coinvestigator Bessel van der Kolk, MD, professor of psychiatry at Boston University School of Medicine, told delegates attending the virtual European Psychiatric Association (EPA) 2021 Congress.
Growing interest
, particularly because failure rates with most available evidence-based treatments have been relatively high.
As previously reported by this news organization, in 2017, the U.S. Food and Drug Administration approved the trial design of Dr. van der Kolk’s and colleagues’ MAPP1 study after granting MDMA breakthrough designation.
The MAPP1 investigators assessed 90 patients with PTSD (mean age, 41 years; 77% White; 66% women) from 50 sites. For the majority of patients (84%), trauma history was developmental. “In other words, trauma [occurred] very early in life, usually at the hands of their own caregivers,” Dr. van der Kolk noted.
In addition, 18% of the patients were veterans, and 12% had combat exposure. The average duration of PTSD before enrollment was 18 years. All patients underwent screening and three preparatory psychotherapy sessions at enrollment.
Participants were randomly assigned to receive MDMA 80 mg or 120 mg (n = 46) or placebo (n = 44) followed by three integrative psychotherapy sessions lasting a total of 8 hours. A supplemental dose of 40 or 60 mg of MDMA could be administered from 1.5 to 2 hours after the first dose.
The patients stayed in the laboratory on the evening of the treatment session and attended a debriefing the next morning. The session was repeated a month later and again a month after that. In between, patients had telephone contact with the raters, who were blinded to the treatment received.
Follow-up assessments were conducted 2 months after the third treatment session and again at 12 months. The primary outcome measure was change in Clinician Administered PTSD Scale for DSM 5 (CAPS-5) score from baseline.
‘Dramatic improvement’
Results showed that both the MDMA and placebo groups experienced a statistically significant improvement in PTSD symptoms, “but MDMA had a dramatically significant improvement, with an effect size of over 0.9,” Dr. van der Kolk said.
The MDMA group also reported enhanced mood and well-being, increased responsiveness to emotional and sensory stimuli, a greater sense of closeness to other people, and a greater feeling of empathy.
Patients also reported having heightened openness, “and clearly the issue of empathy for themselves and others was a very large part of the process,” said Dr. van der Kolk.
“But for me, the most interesting part of the study is that the Adverse Childhood Experiences scale had no effect,” he noted. In other words, “the amount of childhood adverse experiences did not predict outcomes, which was very surprising because usually those patients are very treatment resistant.”
Dr. van der Kolk added that the dissociative subtype of PTSD was first described in the DSM-5 and that patients are “notoriously unresponsive to most unconventional treatments.”
In the current study, 13 patients met the criteria for the subtype, and investigators found they “did better than people with classical PTSD,” Dr. van der Kolk said. He added that this is a “very, very important finding.”
Carefully controlled
Overall, 82% of patients reported a significant improvement by the end of the study; 56% reported that they no longer had PTSD.
In addition, 67% of patients no longer met diagnostic criteria for PTSD. These included patients who had crossed over to active treatment from the placebo group.
Eleven patients (12%) experienced relapse by 12 months; in nine of the cases, this was due to the presence of additional stressors.
There were “very few adverse side effects” during the study, Dr. van der Kolk noted. In addition, “there were really no serious mental side effects,” despite the patients’ “opening up so much very painful material,” he added.
The most common adverse events among the MDMA group were muscle tightness (63%), decreased appetite (52%), nausea (30%), hyperhidrosis (20%), and feeling cold (20%). These effects were “quite small [and] the sort of side effects you would expect in response to an amphetamine substance like MDMA,” said Dr. van der Kolk.
“An important reason why we think the side effect profile is so good is because the study was extremely carefully done, very carefully controlled,” he added. “There was a great deal of support, [and] we paid an enormous amount of attention to creating a very safe context in which this drug was being used.”
However, he expressed concern that “as people see the very good results, they may skimp a little bit on the creation of the context and not have as careful a psychotherapy protocol as we had here.”
‘On the right track’
Commenting on the findings for this news organization, David Nutt, MD, PhD, Edmond J. Safra Professor of Neuropsychopharmacology, Imperial College London, said the results are proof that the investigators’ “earlier smaller trials of MDMA were on the right track.”
“This larger and multicenter trial shows that MDMA therapy can be broadened into newer research groups, which augurs well for the much larger rollout that will be required once it gets a license,” said Dr. Nutt, who was not involved with the research.
He added, “the prior evidence of the safety of MDMA has [now] been confirmed.”
The study represents an “important step in the path to the clinical use of MDMA for PTSD,” Dr. Nutt said.
The study was sponsored by the Multidisciplinary Association for Psychedelic Studies. The investigators and Dr. Nutt have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New global telepsychiatry guidelines released
The World Psychiatric Association (WPA) has released new global telemedicine guidelines.
Prompted by the worldwide explosion of interest in telepsychiatry driven by the COVID-19 pandemic, the guidelines emphasize the need for international collaboration in psychiatry.
“Global teamwork is the light at the end of the tunnel” of the current crisis, lead author Davor Mucic, MD, The Little Prince Treatment Center, Copenhagen, told meeting attendees.
“Now is the time to build a user-friendly digital health care system that can better meet the inevitable future challenges,” Dr. Mucic said. “The hope is that WPA’s global guidelines for telepsychiatry can help us to move forward.”
The guidelines, which also address concerns over data security and device intercompatibility, were presented at the virtual European Psychiatric Association (EPA) 2021 Congress.
Breaking down barriers
Although telepsychiatry has been around since 1959, only with the rapid technologic advances of the past decade has it become available to the majority of psychiatric patients, Dr. Mucic noted.
“Unfortunately, regulatory constraints, in combination with clinicians’ concerns, kept telepsychiatry from being widely adopted and implemented prior to the current COVID-19 pandemic,” he added.
Concerns have been with regard to data safety, reimbursement for consultations, quality of care, lack of technical experience, and difficulties in changing routines.
For many clinicians, the pandemic was the “first time they used telepsychiatry, and very few have received training in how to do it,” Dr. Mucic said.
He pointed out that , including the 2018 Best Practices in Videoconferencing-Based Telemental Health, released by the American Psychiatric Association and the American Telemedicine Association.
Dr. Mucic noted that because these documents are relevant and useful, clinicians may wonder, “Why do we need another set of guidelines?”
He explained that the current WPA guidelines outline universal recommendations that apply “regardless of local or regional regulations.” Therefore, they can be used just as easily in low- and middle-income countries as in countries where telepsychiatry is already established.
A new paradigm
Similar to other guidelines, the WPA’s guidelines discuss legal and regulatory requirements, informed consent, billing and reimbursement, patient selection, clinician training, the clinical setting, and more.
However, what makes the new document “so new and special” is that it opens the door to “some new and previously undiscussed aspects of telepsychiatry ... that are capable of changing the whole delivery of mental health care,” Dr. Mucic said.
The first of these new aspects is in regard to cross-cultural telepsychiatry. The goal is to eliminate the need for interpreters or competency in a different language for patients who do not speak the host country’s language by connecting them remotely with a bilingual health care professional who shares their cultural or ethnic background.
This “ethnic matching” model may lead to a “more precise and detailed symptomatology,” the authors note. They add that minimizing the risk for misinterpretation and misunderstanding can enable better diagnosis and treatment.
The second area highlighted by Dr. Mucic is in regard to international telepsychiatry; the technology could be used to obtain a second opinion from colleagues who share the relevant cultural and linguistic background.
“Further, international expertise may be brought via [telepsychiatry] to local health workers as a part of education, supervision, and scientific collaboration,” he said.
“The hope is the guidelines will pave the way for improved international collaboration, not only by clinicians but also by policymakers.”
A blended future?
Also at EPA 2021, two experts debated whether the COVID-19 pandemic represented a turning point for e-health in psychiatry.
Taking the pro stance, Heleen Riper, PhD, professor of eMental-Health at the Vrije Universiteit Amsterdam, argued that the future is likely to blend face-to-face interaction with video conferencing.
She believes that to maintain current progress, the focus should be on treatment personalization, engagement, and improvement, rather than cost-effectiveness.
Hans-Jürgen Möller, MD, professor emeritus, department of psychiatry, Ludwig-Maximilians-University, Munich, argued against the idea that e-health represented a turning point in psychiatry. He noted that a survey of German psychotherapists indicated that there have been a number of drawbacks to video sessions during the pandemic.
These included that the technology was not available or could be used by all patients, especially the elderly, and that unstable internet connections have posed a problem. Moreover, video conferencing is considered a “poor substitute” for face-to-face interactions by many patients.
In the subsequent discussion, Dr. Möller told this news organization that he believes guidelines in this area are important, especially to differentiate among various offerings on the internet, some of which are “not very good,” and to help patients identify those that are “very well established.”
Dr. Riper agreed, saying that several initiatives to introduce guidelines at the European level are now underway.
The biggest challenge from a technological standpoint is to offer flexibility to patients while still applying “therapeutic principles,” she noted.
“There is a need for guidelines, but those guidelines need to be open to a certain amount of flexibility if you really want to upscale technology into routine care,” Dr. Riper said.
Cautious optimism
Session chair Judit Simon, MD, DPhil, professor of health economics, Medical University of Vienna, asked the debaters whether video interventions will continue to replace in-person interventions once the pandemic is over or whether things will return to “where we were prepandemic.”
Dr. Riper said she did not believe that clinicians will return completely to in-patient practice. However, she emphasized the need for training and the development of new skills to improve the therapeutic relationship with patients.
Although Dr. Riper believes there is still a need for in-person doctor/patient interactions, “we will never get back to the pre-COVID phase, both in terms of diagnostics and treatment,” she said.
Dr. Möller added that although he has “some reservations” regarding the adoption of technologies by older patients and the lack of long-term data on telepsychiatry, he partially shares Dr. Riper’s optimism.
He suggested that there is an opportunity in psychiatry to use video conferencing for multidisciplinary team meetings similar to those seen in oncology.
This would allow discussion of patient diagnosis and treatment and would enable experts in mental health to help clinicians in other specialties. For example, it could help a general practitioner differentiate between depression and a depressive phase of schizophrenia, Dr. Riper said.
The presenters have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The World Psychiatric Association (WPA) has released new global telemedicine guidelines.
Prompted by the worldwide explosion of interest in telepsychiatry driven by the COVID-19 pandemic, the guidelines emphasize the need for international collaboration in psychiatry.
“Global teamwork is the light at the end of the tunnel” of the current crisis, lead author Davor Mucic, MD, The Little Prince Treatment Center, Copenhagen, told meeting attendees.
“Now is the time to build a user-friendly digital health care system that can better meet the inevitable future challenges,” Dr. Mucic said. “The hope is that WPA’s global guidelines for telepsychiatry can help us to move forward.”
The guidelines, which also address concerns over data security and device intercompatibility, were presented at the virtual European Psychiatric Association (EPA) 2021 Congress.
Breaking down barriers
Although telepsychiatry has been around since 1959, only with the rapid technologic advances of the past decade has it become available to the majority of psychiatric patients, Dr. Mucic noted.
“Unfortunately, regulatory constraints, in combination with clinicians’ concerns, kept telepsychiatry from being widely adopted and implemented prior to the current COVID-19 pandemic,” he added.
Concerns have been with regard to data safety, reimbursement for consultations, quality of care, lack of technical experience, and difficulties in changing routines.
For many clinicians, the pandemic was the “first time they used telepsychiatry, and very few have received training in how to do it,” Dr. Mucic said.
He pointed out that , including the 2018 Best Practices in Videoconferencing-Based Telemental Health, released by the American Psychiatric Association and the American Telemedicine Association.
Dr. Mucic noted that because these documents are relevant and useful, clinicians may wonder, “Why do we need another set of guidelines?”
He explained that the current WPA guidelines outline universal recommendations that apply “regardless of local or regional regulations.” Therefore, they can be used just as easily in low- and middle-income countries as in countries where telepsychiatry is already established.
A new paradigm
Similar to other guidelines, the WPA’s guidelines discuss legal and regulatory requirements, informed consent, billing and reimbursement, patient selection, clinician training, the clinical setting, and more.
However, what makes the new document “so new and special” is that it opens the door to “some new and previously undiscussed aspects of telepsychiatry ... that are capable of changing the whole delivery of mental health care,” Dr. Mucic said.
The first of these new aspects is in regard to cross-cultural telepsychiatry. The goal is to eliminate the need for interpreters or competency in a different language for patients who do not speak the host country’s language by connecting them remotely with a bilingual health care professional who shares their cultural or ethnic background.
This “ethnic matching” model may lead to a “more precise and detailed symptomatology,” the authors note. They add that minimizing the risk for misinterpretation and misunderstanding can enable better diagnosis and treatment.
The second area highlighted by Dr. Mucic is in regard to international telepsychiatry; the technology could be used to obtain a second opinion from colleagues who share the relevant cultural and linguistic background.
“Further, international expertise may be brought via [telepsychiatry] to local health workers as a part of education, supervision, and scientific collaboration,” he said.
“The hope is the guidelines will pave the way for improved international collaboration, not only by clinicians but also by policymakers.”
A blended future?
Also at EPA 2021, two experts debated whether the COVID-19 pandemic represented a turning point for e-health in psychiatry.
Taking the pro stance, Heleen Riper, PhD, professor of eMental-Health at the Vrije Universiteit Amsterdam, argued that the future is likely to blend face-to-face interaction with video conferencing.
She believes that to maintain current progress, the focus should be on treatment personalization, engagement, and improvement, rather than cost-effectiveness.
Hans-Jürgen Möller, MD, professor emeritus, department of psychiatry, Ludwig-Maximilians-University, Munich, argued against the idea that e-health represented a turning point in psychiatry. He noted that a survey of German psychotherapists indicated that there have been a number of drawbacks to video sessions during the pandemic.
These included that the technology was not available or could be used by all patients, especially the elderly, and that unstable internet connections have posed a problem. Moreover, video conferencing is considered a “poor substitute” for face-to-face interactions by many patients.
In the subsequent discussion, Dr. Möller told this news organization that he believes guidelines in this area are important, especially to differentiate among various offerings on the internet, some of which are “not very good,” and to help patients identify those that are “very well established.”
Dr. Riper agreed, saying that several initiatives to introduce guidelines at the European level are now underway.
The biggest challenge from a technological standpoint is to offer flexibility to patients while still applying “therapeutic principles,” she noted.
“There is a need for guidelines, but those guidelines need to be open to a certain amount of flexibility if you really want to upscale technology into routine care,” Dr. Riper said.
Cautious optimism
Session chair Judit Simon, MD, DPhil, professor of health economics, Medical University of Vienna, asked the debaters whether video interventions will continue to replace in-person interventions once the pandemic is over or whether things will return to “where we were prepandemic.”
Dr. Riper said she did not believe that clinicians will return completely to in-patient practice. However, she emphasized the need for training and the development of new skills to improve the therapeutic relationship with patients.
Although Dr. Riper believes there is still a need for in-person doctor/patient interactions, “we will never get back to the pre-COVID phase, both in terms of diagnostics and treatment,” she said.
Dr. Möller added that although he has “some reservations” regarding the adoption of technologies by older patients and the lack of long-term data on telepsychiatry, he partially shares Dr. Riper’s optimism.
He suggested that there is an opportunity in psychiatry to use video conferencing for multidisciplinary team meetings similar to those seen in oncology.
This would allow discussion of patient diagnosis and treatment and would enable experts in mental health to help clinicians in other specialties. For example, it could help a general practitioner differentiate between depression and a depressive phase of schizophrenia, Dr. Riper said.
The presenters have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The World Psychiatric Association (WPA) has released new global telemedicine guidelines.
Prompted by the worldwide explosion of interest in telepsychiatry driven by the COVID-19 pandemic, the guidelines emphasize the need for international collaboration in psychiatry.
“Global teamwork is the light at the end of the tunnel” of the current crisis, lead author Davor Mucic, MD, The Little Prince Treatment Center, Copenhagen, told meeting attendees.
“Now is the time to build a user-friendly digital health care system that can better meet the inevitable future challenges,” Dr. Mucic said. “The hope is that WPA’s global guidelines for telepsychiatry can help us to move forward.”
The guidelines, which also address concerns over data security and device intercompatibility, were presented at the virtual European Psychiatric Association (EPA) 2021 Congress.
Breaking down barriers
Although telepsychiatry has been around since 1959, only with the rapid technologic advances of the past decade has it become available to the majority of psychiatric patients, Dr. Mucic noted.
“Unfortunately, regulatory constraints, in combination with clinicians’ concerns, kept telepsychiatry from being widely adopted and implemented prior to the current COVID-19 pandemic,” he added.
Concerns have been with regard to data safety, reimbursement for consultations, quality of care, lack of technical experience, and difficulties in changing routines.
For many clinicians, the pandemic was the “first time they used telepsychiatry, and very few have received training in how to do it,” Dr. Mucic said.
He pointed out that , including the 2018 Best Practices in Videoconferencing-Based Telemental Health, released by the American Psychiatric Association and the American Telemedicine Association.
Dr. Mucic noted that because these documents are relevant and useful, clinicians may wonder, “Why do we need another set of guidelines?”
He explained that the current WPA guidelines outline universal recommendations that apply “regardless of local or regional regulations.” Therefore, they can be used just as easily in low- and middle-income countries as in countries where telepsychiatry is already established.
A new paradigm
Similar to other guidelines, the WPA’s guidelines discuss legal and regulatory requirements, informed consent, billing and reimbursement, patient selection, clinician training, the clinical setting, and more.
However, what makes the new document “so new and special” is that it opens the door to “some new and previously undiscussed aspects of telepsychiatry ... that are capable of changing the whole delivery of mental health care,” Dr. Mucic said.
The first of these new aspects is in regard to cross-cultural telepsychiatry. The goal is to eliminate the need for interpreters or competency in a different language for patients who do not speak the host country’s language by connecting them remotely with a bilingual health care professional who shares their cultural or ethnic background.
This “ethnic matching” model may lead to a “more precise and detailed symptomatology,” the authors note. They add that minimizing the risk for misinterpretation and misunderstanding can enable better diagnosis and treatment.
The second area highlighted by Dr. Mucic is in regard to international telepsychiatry; the technology could be used to obtain a second opinion from colleagues who share the relevant cultural and linguistic background.
“Further, international expertise may be brought via [telepsychiatry] to local health workers as a part of education, supervision, and scientific collaboration,” he said.
“The hope is the guidelines will pave the way for improved international collaboration, not only by clinicians but also by policymakers.”
A blended future?
Also at EPA 2021, two experts debated whether the COVID-19 pandemic represented a turning point for e-health in psychiatry.
Taking the pro stance, Heleen Riper, PhD, professor of eMental-Health at the Vrije Universiteit Amsterdam, argued that the future is likely to blend face-to-face interaction with video conferencing.
She believes that to maintain current progress, the focus should be on treatment personalization, engagement, and improvement, rather than cost-effectiveness.
Hans-Jürgen Möller, MD, professor emeritus, department of psychiatry, Ludwig-Maximilians-University, Munich, argued against the idea that e-health represented a turning point in psychiatry. He noted that a survey of German psychotherapists indicated that there have been a number of drawbacks to video sessions during the pandemic.
These included that the technology was not available or could be used by all patients, especially the elderly, and that unstable internet connections have posed a problem. Moreover, video conferencing is considered a “poor substitute” for face-to-face interactions by many patients.
In the subsequent discussion, Dr. Möller told this news organization that he believes guidelines in this area are important, especially to differentiate among various offerings on the internet, some of which are “not very good,” and to help patients identify those that are “very well established.”
Dr. Riper agreed, saying that several initiatives to introduce guidelines at the European level are now underway.
The biggest challenge from a technological standpoint is to offer flexibility to patients while still applying “therapeutic principles,” she noted.
“There is a need for guidelines, but those guidelines need to be open to a certain amount of flexibility if you really want to upscale technology into routine care,” Dr. Riper said.
Cautious optimism
Session chair Judit Simon, MD, DPhil, professor of health economics, Medical University of Vienna, asked the debaters whether video interventions will continue to replace in-person interventions once the pandemic is over or whether things will return to “where we were prepandemic.”
Dr. Riper said she did not believe that clinicians will return completely to in-patient practice. However, she emphasized the need for training and the development of new skills to improve the therapeutic relationship with patients.
Although Dr. Riper believes there is still a need for in-person doctor/patient interactions, “we will never get back to the pre-COVID phase, both in terms of diagnostics and treatment,” she said.
Dr. Möller added that although he has “some reservations” regarding the adoption of technologies by older patients and the lack of long-term data on telepsychiatry, he partially shares Dr. Riper’s optimism.
He suggested that there is an opportunity in psychiatry to use video conferencing for multidisciplinary team meetings similar to those seen in oncology.
This would allow discussion of patient diagnosis and treatment and would enable experts in mental health to help clinicians in other specialties. For example, it could help a general practitioner differentiate between depression and a depressive phase of schizophrenia, Dr. Riper said.
The presenters have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women with PCOS at increased risk for COVID-19
Women with polycystic ovary syndrome (PCOS) face an almost 30% increased risk for COVID-19 compared with unaffected women, even after adjusting for cardiometabolic and other related factors, suggests an analysis of United Kingdom primary care data.
“Our research has highlighted that women with PCOS are an often overlooked and potentially high-risk population for contracting COVID-19,” said joint senior author Wiebke Arlt, MD, PhD, director of the Institute of Metabolism and Systems Research at the University of Birmingham (England), in a press release.
“Before the onset of the COVID-19 pandemic, women with PCOS consistently report fragmented care, delayed diagnosis and a perception of poor clinician understanding of their condition,” added co-author Michael W. O’Reilly, MD, PhD, University of Medicine and Health Sciences, Dublin.
“Women suffering from this condition may fear, with some degree of justification, that an enhanced risk of COVID-19 infection will further compromise timely access to health care and serve to increase the sense of disenfranchisement currently experienced by many patients,” he added.
Consequently, “these findings need to be considered when designing public health policy and advice as our understanding of COVID-19 evolves,” noted first author Anuradhaa Subramanian, PhD Student, Institute of Applied Health Research, University of Birmingham.
The research was published by the European Journal of Endocrinology on March 9.
Women with PCOS: A distinct subgroup?
PCOS, which is thought to affect up to 16% of women, is associated with a significantly increased risk for type 2 diabetes, non-alcoholic fatty liver disease, and cardiovascular disease, all which have been linked to more severe COVID-19.
The condition is more prevalent in Black and South Asian women, who also appear to have an increased risk for severe COVID-19 vs. their White counterparts.
However, women and younger people in general have a lower overall risk for severe COVID-19 and mortality compared with older people and men.
Women with PCOS may therefore “represent a distinct subgroup of women at higher than average [on the basis of their sex and age] risk of adverse COVID-19–related outcomes,” the researchers note.
To investigate further, they collated data from The Health Improvement Network primary care database, which includes information from 365 active general practices in the U.K. for the period Jan. 31, 2020, to July 22, 2020.
They identified women with PCOS or a coded diagnosis of polycystic ovaries (PCO), and then for each woman randomly selected four unaffected controls matched for age and general practice location.
They included 21,292 women with PCOS/PCO and 78,310 controls, who had a mean age at study entry of 39.3 years and 39.5 years, respectively. The mean age at diagnosis of PCOS was 27 years, and the mean duration of the condition was 12.4 years.
The crude incidence of COVID-19 was 18.1 per 1000 person-years among women with PCOS vs. 11.9 per 1000 person-years in those without.
Cox regression analysis adjusted for age indicated that women with PCOS faced a significantly increased risk for COVID-19 than those without, at a hazard ratio of 1.51 (P < .001).
Further adjustment for body mass index (BMI) and age reduced the hazard ratio to 1.36 (P = .001).
In the fully adjusted model, which also took into account impaired glucose regulation, androgen excess, anovulation, hypertension, and other PCOS-related factors, the hazard ratio remained significant, at 1.28 (P = .015).
For shielding, balance benefits with impact on mental health
Joint senior author Krishnarajah Nirantharakumar, MD, PhD, also of the University of Birmingham, commented that, despite the increased risks, shielding strategies for COVID-19 need to take into account the impact of PCOS on women’s mental health.
“The risk of mental health problems, including low self-esteem, anxiety, and depression, is significantly higher in women with PCOS,” he said, “and advice on strict adherence to social distancing needs to be tempered by the associated risk of exacerbating these underlying problems.”
Arlt also pointed out that the study only looked at the incidence of COVID-19 infection, rather than outcomes.
“Our study does not provide information on the risk of a severe course of the COVID-19 infection or on the risk of COVID-19–related long-term complications [in women with PCOS], and further research is required,” she concluded.
The study was funded by Health Data Research UK and supported by the Wellcome Trust, the Health Research Board, and the National Institute for Health Research Birmingham Biomedical Research Centre based at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. The study authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women with polycystic ovary syndrome (PCOS) face an almost 30% increased risk for COVID-19 compared with unaffected women, even after adjusting for cardiometabolic and other related factors, suggests an analysis of United Kingdom primary care data.
“Our research has highlighted that women with PCOS are an often overlooked and potentially high-risk population for contracting COVID-19,” said joint senior author Wiebke Arlt, MD, PhD, director of the Institute of Metabolism and Systems Research at the University of Birmingham (England), in a press release.
“Before the onset of the COVID-19 pandemic, women with PCOS consistently report fragmented care, delayed diagnosis and a perception of poor clinician understanding of their condition,” added co-author Michael W. O’Reilly, MD, PhD, University of Medicine and Health Sciences, Dublin.
“Women suffering from this condition may fear, with some degree of justification, that an enhanced risk of COVID-19 infection will further compromise timely access to health care and serve to increase the sense of disenfranchisement currently experienced by many patients,” he added.
Consequently, “these findings need to be considered when designing public health policy and advice as our understanding of COVID-19 evolves,” noted first author Anuradhaa Subramanian, PhD Student, Institute of Applied Health Research, University of Birmingham.
The research was published by the European Journal of Endocrinology on March 9.
Women with PCOS: A distinct subgroup?
PCOS, which is thought to affect up to 16% of women, is associated with a significantly increased risk for type 2 diabetes, non-alcoholic fatty liver disease, and cardiovascular disease, all which have been linked to more severe COVID-19.
The condition is more prevalent in Black and South Asian women, who also appear to have an increased risk for severe COVID-19 vs. their White counterparts.
However, women and younger people in general have a lower overall risk for severe COVID-19 and mortality compared with older people and men.
Women with PCOS may therefore “represent a distinct subgroup of women at higher than average [on the basis of their sex and age] risk of adverse COVID-19–related outcomes,” the researchers note.
To investigate further, they collated data from The Health Improvement Network primary care database, which includes information from 365 active general practices in the U.K. for the period Jan. 31, 2020, to July 22, 2020.
They identified women with PCOS or a coded diagnosis of polycystic ovaries (PCO), and then for each woman randomly selected four unaffected controls matched for age and general practice location.
They included 21,292 women with PCOS/PCO and 78,310 controls, who had a mean age at study entry of 39.3 years and 39.5 years, respectively. The mean age at diagnosis of PCOS was 27 years, and the mean duration of the condition was 12.4 years.
The crude incidence of COVID-19 was 18.1 per 1000 person-years among women with PCOS vs. 11.9 per 1000 person-years in those without.
Cox regression analysis adjusted for age indicated that women with PCOS faced a significantly increased risk for COVID-19 than those without, at a hazard ratio of 1.51 (P < .001).
Further adjustment for body mass index (BMI) and age reduced the hazard ratio to 1.36 (P = .001).
In the fully adjusted model, which also took into account impaired glucose regulation, androgen excess, anovulation, hypertension, and other PCOS-related factors, the hazard ratio remained significant, at 1.28 (P = .015).
For shielding, balance benefits with impact on mental health
Joint senior author Krishnarajah Nirantharakumar, MD, PhD, also of the University of Birmingham, commented that, despite the increased risks, shielding strategies for COVID-19 need to take into account the impact of PCOS on women’s mental health.
“The risk of mental health problems, including low self-esteem, anxiety, and depression, is significantly higher in women with PCOS,” he said, “and advice on strict adherence to social distancing needs to be tempered by the associated risk of exacerbating these underlying problems.”
Arlt also pointed out that the study only looked at the incidence of COVID-19 infection, rather than outcomes.
“Our study does not provide information on the risk of a severe course of the COVID-19 infection or on the risk of COVID-19–related long-term complications [in women with PCOS], and further research is required,” she concluded.
The study was funded by Health Data Research UK and supported by the Wellcome Trust, the Health Research Board, and the National Institute for Health Research Birmingham Biomedical Research Centre based at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. The study authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women with polycystic ovary syndrome (PCOS) face an almost 30% increased risk for COVID-19 compared with unaffected women, even after adjusting for cardiometabolic and other related factors, suggests an analysis of United Kingdom primary care data.
“Our research has highlighted that women with PCOS are an often overlooked and potentially high-risk population for contracting COVID-19,” said joint senior author Wiebke Arlt, MD, PhD, director of the Institute of Metabolism and Systems Research at the University of Birmingham (England), in a press release.
“Before the onset of the COVID-19 pandemic, women with PCOS consistently report fragmented care, delayed diagnosis and a perception of poor clinician understanding of their condition,” added co-author Michael W. O’Reilly, MD, PhD, University of Medicine and Health Sciences, Dublin.
“Women suffering from this condition may fear, with some degree of justification, that an enhanced risk of COVID-19 infection will further compromise timely access to health care and serve to increase the sense of disenfranchisement currently experienced by many patients,” he added.
Consequently, “these findings need to be considered when designing public health policy and advice as our understanding of COVID-19 evolves,” noted first author Anuradhaa Subramanian, PhD Student, Institute of Applied Health Research, University of Birmingham.
The research was published by the European Journal of Endocrinology on March 9.
Women with PCOS: A distinct subgroup?
PCOS, which is thought to affect up to 16% of women, is associated with a significantly increased risk for type 2 diabetes, non-alcoholic fatty liver disease, and cardiovascular disease, all which have been linked to more severe COVID-19.
The condition is more prevalent in Black and South Asian women, who also appear to have an increased risk for severe COVID-19 vs. their White counterparts.
However, women and younger people in general have a lower overall risk for severe COVID-19 and mortality compared with older people and men.
Women with PCOS may therefore “represent a distinct subgroup of women at higher than average [on the basis of their sex and age] risk of adverse COVID-19–related outcomes,” the researchers note.
To investigate further, they collated data from The Health Improvement Network primary care database, which includes information from 365 active general practices in the U.K. for the period Jan. 31, 2020, to July 22, 2020.
They identified women with PCOS or a coded diagnosis of polycystic ovaries (PCO), and then for each woman randomly selected four unaffected controls matched for age and general practice location.
They included 21,292 women with PCOS/PCO and 78,310 controls, who had a mean age at study entry of 39.3 years and 39.5 years, respectively. The mean age at diagnosis of PCOS was 27 years, and the mean duration of the condition was 12.4 years.
The crude incidence of COVID-19 was 18.1 per 1000 person-years among women with PCOS vs. 11.9 per 1000 person-years in those without.
Cox regression analysis adjusted for age indicated that women with PCOS faced a significantly increased risk for COVID-19 than those without, at a hazard ratio of 1.51 (P < .001).
Further adjustment for body mass index (BMI) and age reduced the hazard ratio to 1.36 (P = .001).
In the fully adjusted model, which also took into account impaired glucose regulation, androgen excess, anovulation, hypertension, and other PCOS-related factors, the hazard ratio remained significant, at 1.28 (P = .015).
For shielding, balance benefits with impact on mental health
Joint senior author Krishnarajah Nirantharakumar, MD, PhD, also of the University of Birmingham, commented that, despite the increased risks, shielding strategies for COVID-19 need to take into account the impact of PCOS on women’s mental health.
“The risk of mental health problems, including low self-esteem, anxiety, and depression, is significantly higher in women with PCOS,” he said, “and advice on strict adherence to social distancing needs to be tempered by the associated risk of exacerbating these underlying problems.”
Arlt also pointed out that the study only looked at the incidence of COVID-19 infection, rather than outcomes.
“Our study does not provide information on the risk of a severe course of the COVID-19 infection or on the risk of COVID-19–related long-term complications [in women with PCOS], and further research is required,” she concluded.
The study was funded by Health Data Research UK and supported by the Wellcome Trust, the Health Research Board, and the National Institute for Health Research Birmingham Biomedical Research Centre based at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust. The study authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Increase in thyroid cancer rates points to overscreening
The researchers say this is “likely to be due to the effect of intense scrutiny of the thyroid gland ... in middle-aged individuals” with sensitive imaging such as ultrasonography or CT.
There is “a lot of evidence” to suggest that this is leading to overdiagnosis, lead author Adalberto Miranda-Filho, PhD, told this news organization. The degree of overdiagnosis depends on the “diagnostic pressure” resulting from opportunistic screening.
The potential for cancer overdiagnosis, including thyroid cancer, was recently estimated to be about 20% for five common types, and there have been calls to relabel low-risk lesions as something other than cancer.
Dr. Miranda-Filho does not believe that subclinical papillary thyroid cancer should be renamed, because that would “require agreement of pathologists and other researchers,” although he said it is “important to explain that not all ‘cancers’ can evolve into a life-threatening disease.”
Screening for thyroid cancer is not currently recommended because it could increase the risk for patient harms without improving outcomes, explained Dr. Miranda-Filho of the Cancer Surveillance Branch, International Agency for Research on Cancer, Lyon, France.
The research was published on March 1 in The Lancet Diabetes and Endocrinology.
Papillary thyroid cancers increased in all countries
Thyroid cancer, which includes a range of histologic subtypes, accounts for 3% of cancer diagnoses globally, the team writes. It is estimated that there were 586,000 new patients in 2020.
Recent evidence suggests the incidence has risen substantially in many high- and medium-income countries over the past 30 years, although there is wide variation between and within populations. Moreover, mortality rates for thyroid cancer have decreased or remained stable.
To investigate this further, the French researchers examined data on thyroid cancer incidence collated by the IARC for the period 1998-2012. They focused on 25 countries from Europe, the Americas, Asia, and Oceania, which have cancer registries that cover more than 2 million of their population.
The analyses were restricted to individuals aged 20-84 years, and the proportion of cases of unspecified thyroid cancer had to be less than 10%.
Data on almost 150,000 thyroid cancer cases were examined, including 59,499 from South Korea, 15,535 from the United States, 15,158 from Canada, 8,684 from the United Kingdom, 8,106 from Australia, and 3,806 from China.
Across all countries, papillary thyroid cancer was the main contributor to thyroid cancer cases. Despite wide variations between countries, it was the only histologic subtype that increased in incidence in all countries.
For the period 2008-2012, the age-standardized incidence rate for papillary thyroid cancer in women ranged from 4.3 to 5.3 per 100,000 person-years in the Netherlands, the United Kingdom, and Denmark to 143.3 cases per 100,000 person-years in South Korea.
Among men, the age-standardized incidence rate ranged from 1.2 to 1.6 per 100,000 person-years in Thailand, Bulgaria, and the Netherlands to 30.7 per 100,000 person-years in South Korea.
Over the whole study period, rates of papillary thyroid cancer increased in both men and women, with large variability between countries. The increases in women were rapid and exceeded 20 cases per 100,000 in several countries, most notably, South Korea.
Interestingly, incidence rates in South Korea, China, Japan, and Turkey were low and stable until the 2000s and then rose markedly, whereas the increase in incidence in the United States, Austria, Croatia, Germany, Slovenia, Spain, Lithuania, and Bulgaria stabilized around 2009.
Not much change in incidence rates for other subtypes of thyroid cancer
For other histologic subtypes of thyroid cancer, the trends in incidence rates were relatively stable and low.
However, some countries, such as the United States, China, South Korea, Turkey, and some Northern European countries, saw increases in follicular thyroid cancer, albeit at much lower rates than for papillary thyroid cancer.
Overall, age-standardized rates for follicular thyroid cancer ranged from 0.5 to 2.5 per 100,000 person-years among women and from 0.3 to 1.5 per 100,000 person-years among men. Rates for medullary thyroid cancer were less than one per 100,000 person-years among men and women. For the anaplastic subtype, rates were less than 0.2 per 100,000 person-years.
The team notes that small decreases in anaplastic thyroid cancer rates across the study period were recorded in 21 countries, including Colombia, Lithuania, Bulgaria, Slovenia, Germany, and Norway.
However, Dr. Miranda-Filho said that overall, the incidence rate of anaplastic thyroid cancer “seems to be not affected by the intensity of screening,” whereas the “lack of evidence” on changing trends for follicular disease suggests that opportunistic screening allows only non–life-threatening tumors to emerge “from a large reservoir of subclinical asymptomatic neoplasms in the thyroid glands.”
The study was supported by the French Institut National du Cancer, the Italian Association for Cancer Research, and the Italian Ministry of Health to Centro di Riferimento Oncologico di Aviano. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The researchers say this is “likely to be due to the effect of intense scrutiny of the thyroid gland ... in middle-aged individuals” with sensitive imaging such as ultrasonography or CT.
There is “a lot of evidence” to suggest that this is leading to overdiagnosis, lead author Adalberto Miranda-Filho, PhD, told this news organization. The degree of overdiagnosis depends on the “diagnostic pressure” resulting from opportunistic screening.
The potential for cancer overdiagnosis, including thyroid cancer, was recently estimated to be about 20% for five common types, and there have been calls to relabel low-risk lesions as something other than cancer.
Dr. Miranda-Filho does not believe that subclinical papillary thyroid cancer should be renamed, because that would “require agreement of pathologists and other researchers,” although he said it is “important to explain that not all ‘cancers’ can evolve into a life-threatening disease.”
Screening for thyroid cancer is not currently recommended because it could increase the risk for patient harms without improving outcomes, explained Dr. Miranda-Filho of the Cancer Surveillance Branch, International Agency for Research on Cancer, Lyon, France.
The research was published on March 1 in The Lancet Diabetes and Endocrinology.
Papillary thyroid cancers increased in all countries
Thyroid cancer, which includes a range of histologic subtypes, accounts for 3% of cancer diagnoses globally, the team writes. It is estimated that there were 586,000 new patients in 2020.
Recent evidence suggests the incidence has risen substantially in many high- and medium-income countries over the past 30 years, although there is wide variation between and within populations. Moreover, mortality rates for thyroid cancer have decreased or remained stable.
To investigate this further, the French researchers examined data on thyroid cancer incidence collated by the IARC for the period 1998-2012. They focused on 25 countries from Europe, the Americas, Asia, and Oceania, which have cancer registries that cover more than 2 million of their population.
The analyses were restricted to individuals aged 20-84 years, and the proportion of cases of unspecified thyroid cancer had to be less than 10%.
Data on almost 150,000 thyroid cancer cases were examined, including 59,499 from South Korea, 15,535 from the United States, 15,158 from Canada, 8,684 from the United Kingdom, 8,106 from Australia, and 3,806 from China.
Across all countries, papillary thyroid cancer was the main contributor to thyroid cancer cases. Despite wide variations between countries, it was the only histologic subtype that increased in incidence in all countries.
For the period 2008-2012, the age-standardized incidence rate for papillary thyroid cancer in women ranged from 4.3 to 5.3 per 100,000 person-years in the Netherlands, the United Kingdom, and Denmark to 143.3 cases per 100,000 person-years in South Korea.
Among men, the age-standardized incidence rate ranged from 1.2 to 1.6 per 100,000 person-years in Thailand, Bulgaria, and the Netherlands to 30.7 per 100,000 person-years in South Korea.
Over the whole study period, rates of papillary thyroid cancer increased in both men and women, with large variability between countries. The increases in women were rapid and exceeded 20 cases per 100,000 in several countries, most notably, South Korea.
Interestingly, incidence rates in South Korea, China, Japan, and Turkey were low and stable until the 2000s and then rose markedly, whereas the increase in incidence in the United States, Austria, Croatia, Germany, Slovenia, Spain, Lithuania, and Bulgaria stabilized around 2009.
Not much change in incidence rates for other subtypes of thyroid cancer
For other histologic subtypes of thyroid cancer, the trends in incidence rates were relatively stable and low.
However, some countries, such as the United States, China, South Korea, Turkey, and some Northern European countries, saw increases in follicular thyroid cancer, albeit at much lower rates than for papillary thyroid cancer.
Overall, age-standardized rates for follicular thyroid cancer ranged from 0.5 to 2.5 per 100,000 person-years among women and from 0.3 to 1.5 per 100,000 person-years among men. Rates for medullary thyroid cancer were less than one per 100,000 person-years among men and women. For the anaplastic subtype, rates were less than 0.2 per 100,000 person-years.
The team notes that small decreases in anaplastic thyroid cancer rates across the study period were recorded in 21 countries, including Colombia, Lithuania, Bulgaria, Slovenia, Germany, and Norway.
However, Dr. Miranda-Filho said that overall, the incidence rate of anaplastic thyroid cancer “seems to be not affected by the intensity of screening,” whereas the “lack of evidence” on changing trends for follicular disease suggests that opportunistic screening allows only non–life-threatening tumors to emerge “from a large reservoir of subclinical asymptomatic neoplasms in the thyroid glands.”
The study was supported by the French Institut National du Cancer, the Italian Association for Cancer Research, and the Italian Ministry of Health to Centro di Riferimento Oncologico di Aviano. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The researchers say this is “likely to be due to the effect of intense scrutiny of the thyroid gland ... in middle-aged individuals” with sensitive imaging such as ultrasonography or CT.
There is “a lot of evidence” to suggest that this is leading to overdiagnosis, lead author Adalberto Miranda-Filho, PhD, told this news organization. The degree of overdiagnosis depends on the “diagnostic pressure” resulting from opportunistic screening.
The potential for cancer overdiagnosis, including thyroid cancer, was recently estimated to be about 20% for five common types, and there have been calls to relabel low-risk lesions as something other than cancer.
Dr. Miranda-Filho does not believe that subclinical papillary thyroid cancer should be renamed, because that would “require agreement of pathologists and other researchers,” although he said it is “important to explain that not all ‘cancers’ can evolve into a life-threatening disease.”
Screening for thyroid cancer is not currently recommended because it could increase the risk for patient harms without improving outcomes, explained Dr. Miranda-Filho of the Cancer Surveillance Branch, International Agency for Research on Cancer, Lyon, France.
The research was published on March 1 in The Lancet Diabetes and Endocrinology.
Papillary thyroid cancers increased in all countries
Thyroid cancer, which includes a range of histologic subtypes, accounts for 3% of cancer diagnoses globally, the team writes. It is estimated that there were 586,000 new patients in 2020.
Recent evidence suggests the incidence has risen substantially in many high- and medium-income countries over the past 30 years, although there is wide variation between and within populations. Moreover, mortality rates for thyroid cancer have decreased or remained stable.
To investigate this further, the French researchers examined data on thyroid cancer incidence collated by the IARC for the period 1998-2012. They focused on 25 countries from Europe, the Americas, Asia, and Oceania, which have cancer registries that cover more than 2 million of their population.
The analyses were restricted to individuals aged 20-84 years, and the proportion of cases of unspecified thyroid cancer had to be less than 10%.
Data on almost 150,000 thyroid cancer cases were examined, including 59,499 from South Korea, 15,535 from the United States, 15,158 from Canada, 8,684 from the United Kingdom, 8,106 from Australia, and 3,806 from China.
Across all countries, papillary thyroid cancer was the main contributor to thyroid cancer cases. Despite wide variations between countries, it was the only histologic subtype that increased in incidence in all countries.
For the period 2008-2012, the age-standardized incidence rate for papillary thyroid cancer in women ranged from 4.3 to 5.3 per 100,000 person-years in the Netherlands, the United Kingdom, and Denmark to 143.3 cases per 100,000 person-years in South Korea.
Among men, the age-standardized incidence rate ranged from 1.2 to 1.6 per 100,000 person-years in Thailand, Bulgaria, and the Netherlands to 30.7 per 100,000 person-years in South Korea.
Over the whole study period, rates of papillary thyroid cancer increased in both men and women, with large variability between countries. The increases in women were rapid and exceeded 20 cases per 100,000 in several countries, most notably, South Korea.
Interestingly, incidence rates in South Korea, China, Japan, and Turkey were low and stable until the 2000s and then rose markedly, whereas the increase in incidence in the United States, Austria, Croatia, Germany, Slovenia, Spain, Lithuania, and Bulgaria stabilized around 2009.
Not much change in incidence rates for other subtypes of thyroid cancer
For other histologic subtypes of thyroid cancer, the trends in incidence rates were relatively stable and low.
However, some countries, such as the United States, China, South Korea, Turkey, and some Northern European countries, saw increases in follicular thyroid cancer, albeit at much lower rates than for papillary thyroid cancer.
Overall, age-standardized rates for follicular thyroid cancer ranged from 0.5 to 2.5 per 100,000 person-years among women and from 0.3 to 1.5 per 100,000 person-years among men. Rates for medullary thyroid cancer were less than one per 100,000 person-years among men and women. For the anaplastic subtype, rates were less than 0.2 per 100,000 person-years.
The team notes that small decreases in anaplastic thyroid cancer rates across the study period were recorded in 21 countries, including Colombia, Lithuania, Bulgaria, Slovenia, Germany, and Norway.
However, Dr. Miranda-Filho said that overall, the incidence rate of anaplastic thyroid cancer “seems to be not affected by the intensity of screening,” whereas the “lack of evidence” on changing trends for follicular disease suggests that opportunistic screening allows only non–life-threatening tumors to emerge “from a large reservoir of subclinical asymptomatic neoplasms in the thyroid glands.”
The study was supported by the French Institut National du Cancer, the Italian Association for Cancer Research, and the Italian Ministry of Health to Centro di Riferimento Oncologico di Aviano. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Don’t delay: Cancer patients need both doses of COVID vaccine
The new findings, which are soon to be published as a preprint, cast doubt on the current U.K. policy of delaying the second dose of the vaccine.
Delaying the second dose can leave most patients with cancer wholly or partially unprotected, according to the researchers. Moreover, such a delay has implications for transmission of SARS-CoV-2 in the cancer patient’s environs as well as for the evolution of virus variants that could be of concern, the researchers concluded.
The data come from a British study that included 151 patients with cancer and 54 healthy control persons. All participants received the COVID-19 mRNA BNT162b2 vaccine (Pfizer-BioNTech).
This vaccine requires two doses. The first few participants in this study were given the second dose 21 days after they had received the first dose, but then national guidelines changed, and the remaining participants had to wait 12 weeks to receive their second dose.
The researchers reported that, among health controls, the immune efficacy of the first dose was very high (97% efficacious). By contrast, among patients with solid tumors, the immune efficacy of a single dose was strikingly low (39%), and it was even lower in patients with hematologic malignancies (13%).
The second dose of vaccine greatly and rapidly increased the immune efficacy in patients with solid tumors (95% within 2 weeks of receiving the second dose), the researchers added.
Too few patients with hematologic cancers had received the second dose before the study ended for clear conclusions to be drawn. Nevertheless, the available data suggest that 50% of patients with hematologic cancers who had received the booster at day 21 were seropositive at 5 weeks vs. only 8% of those who had not received the booster.
“Our data provide the first real-world evidence of immune efficacy following one dose of the Pfizer vaccine in immunocompromised patient populations [and] clearly show that the poor one-dose efficacy in cancer patients can be rescued with an early booster at day 21,” commented senior author Sheeba Irshad, MD, senior clinical lecturer, King’s College London.
“Based on our findings, we would recommend an urgent review of the vaccine strategy for clinically extremely vulnerable groups. Until then, it is important that cancer patients continue to observe all public health measures in place, such as social distancing and shielding when attending hospitals, even after vaccination,” Dr. Irshad added.
The paper, with first author Leticia Monin-Aldama, PhD, is scheduled to appear on the preprint server medRxiv. It has not undergone peer review. The paper was distributed to journalists, with comments from experts not involved in the study, by the UK Science Media Centre.
These data are “of immediate importance” to patients with cancer, commented Shoba Amarnath, PhD, Newcastle University research fellow, Laboratory of T-cell Regulation, Newcastle University Center for Cancer, Newcastle upon Tyne, England.
“These findings are consistent with our understanding. … We know that the immune system within cancer patients is compromised as compared to healthy controls,” Dr. Amarnath said. “The data in the study support the notion that, in solid cancer patients, a considerable delay in second dose will extend the period when cancer patients are at risk of SARS-CoV-2 infection.”
Although more data are required, “this study does raise the issue of whether patients with cancer, other diseases, or those undergoing therapies that affect the body’s immune response should be fast-tracked for their second vaccine dose,” commented Lawrence Young, PhD, professor of molecular oncology and director of the Warwick Cancer Research Center, University of Warwick, Coventry, England.
Stephen Evans, MSc, professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, underlined that the study is “essentially” observational and “inevitable limitations must be taken into account.
“Nevertheless, these results do suggest that the vaccines may well not protect those patients with cancer as well as those without cancer,” Mr. Evans said. He added that it is “important that this population continues to observe all COVID-19–associated measures, such as social distancing and shielding when attending hospitals, even after vaccination.”
Study details
Previous studies have shown that some patients with cancer have prolonged responses to SARS-CoV-2 infection, with ongoing immune dysregulation, inefficient seroconversion, and prolonged viral shedding.
There are few data, however, on how these patients respond to COVID-19 vaccination. The authors point out that, among the 18,860 individuals who received the Pfizer vaccine during its development trials, “none with an active oncological diagnosis was included.”
To investigate this issue, they launched the SARS-CoV-2 for Cancer Patients (SOAP-02) study.
The 151 patients with cancer who participated in this study were mostly elderly, the authors noted (75% were older than 65 years; the median age was 73 years). The majority (63%) had solid-tumor malignancies. Of those, 8% had late-stage disease and had been living with their cancer for more than 24 months.
The healthy control persons were vaccine-eligible primary health care workers who were not age matched to the cancer patients.
All participants received the first dose of vaccine; 31 (of 151) patients with cancer and 16 (of 54) healthy control persons received the second dose on day 21.
The remaining participants were scheduled to receive their second dose 12 weeks later (after the study ended), in line with the changes in the national guidelines.
The team reported that, approximately 21 days after receiving the first vaccine dose, the immune efficacy of the vaccine was estimated to be 97% among healthy control persons vs. 39% for patients with solid tumors and only 13% for those with hematologic malignancies (P < .0001 for both).
T-cell responses, as assessed via interferon-gamma and/or interleukin-2 production, were observed in 82% of healthy control persons, 71% of patients with solid tumors, and 50% of those with hematologic cancers.
Vaccine boosting at day 21 resulted in immune efficacy of 100% for healthy control persons and 95% for patients with solid tumors. In contrast, only 43% of those who did not receive the second dose were seropositive 2 weeks later.
Further analysis suggested that participants who did not have a serologic response were “spread evenly” across different cancer types, but the reduced responses were more frequent among patients who had received the vaccine within 15 days of cancer treatment, especially chemotherapy, and had undergone intensive treatments.
The SOAP study is sponsored by King’s College London and Guy’s and St. Thomas Trust Foundation NHS Trust. It is funded from grants from the KCL Charity, Cancer Research UK, and program grants from Breast Cancer Now. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The new findings, which are soon to be published as a preprint, cast doubt on the current U.K. policy of delaying the second dose of the vaccine.
Delaying the second dose can leave most patients with cancer wholly or partially unprotected, according to the researchers. Moreover, such a delay has implications for transmission of SARS-CoV-2 in the cancer patient’s environs as well as for the evolution of virus variants that could be of concern, the researchers concluded.
The data come from a British study that included 151 patients with cancer and 54 healthy control persons. All participants received the COVID-19 mRNA BNT162b2 vaccine (Pfizer-BioNTech).
This vaccine requires two doses. The first few participants in this study were given the second dose 21 days after they had received the first dose, but then national guidelines changed, and the remaining participants had to wait 12 weeks to receive their second dose.
The researchers reported that, among health controls, the immune efficacy of the first dose was very high (97% efficacious). By contrast, among patients with solid tumors, the immune efficacy of a single dose was strikingly low (39%), and it was even lower in patients with hematologic malignancies (13%).
The second dose of vaccine greatly and rapidly increased the immune efficacy in patients with solid tumors (95% within 2 weeks of receiving the second dose), the researchers added.
Too few patients with hematologic cancers had received the second dose before the study ended for clear conclusions to be drawn. Nevertheless, the available data suggest that 50% of patients with hematologic cancers who had received the booster at day 21 were seropositive at 5 weeks vs. only 8% of those who had not received the booster.
“Our data provide the first real-world evidence of immune efficacy following one dose of the Pfizer vaccine in immunocompromised patient populations [and] clearly show that the poor one-dose efficacy in cancer patients can be rescued with an early booster at day 21,” commented senior author Sheeba Irshad, MD, senior clinical lecturer, King’s College London.
“Based on our findings, we would recommend an urgent review of the vaccine strategy for clinically extremely vulnerable groups. Until then, it is important that cancer patients continue to observe all public health measures in place, such as social distancing and shielding when attending hospitals, even after vaccination,” Dr. Irshad added.
The paper, with first author Leticia Monin-Aldama, PhD, is scheduled to appear on the preprint server medRxiv. It has not undergone peer review. The paper was distributed to journalists, with comments from experts not involved in the study, by the UK Science Media Centre.
These data are “of immediate importance” to patients with cancer, commented Shoba Amarnath, PhD, Newcastle University research fellow, Laboratory of T-cell Regulation, Newcastle University Center for Cancer, Newcastle upon Tyne, England.
“These findings are consistent with our understanding. … We know that the immune system within cancer patients is compromised as compared to healthy controls,” Dr. Amarnath said. “The data in the study support the notion that, in solid cancer patients, a considerable delay in second dose will extend the period when cancer patients are at risk of SARS-CoV-2 infection.”
Although more data are required, “this study does raise the issue of whether patients with cancer, other diseases, or those undergoing therapies that affect the body’s immune response should be fast-tracked for their second vaccine dose,” commented Lawrence Young, PhD, professor of molecular oncology and director of the Warwick Cancer Research Center, University of Warwick, Coventry, England.
Stephen Evans, MSc, professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, underlined that the study is “essentially” observational and “inevitable limitations must be taken into account.
“Nevertheless, these results do suggest that the vaccines may well not protect those patients with cancer as well as those without cancer,” Mr. Evans said. He added that it is “important that this population continues to observe all COVID-19–associated measures, such as social distancing and shielding when attending hospitals, even after vaccination.”
Study details
Previous studies have shown that some patients with cancer have prolonged responses to SARS-CoV-2 infection, with ongoing immune dysregulation, inefficient seroconversion, and prolonged viral shedding.
There are few data, however, on how these patients respond to COVID-19 vaccination. The authors point out that, among the 18,860 individuals who received the Pfizer vaccine during its development trials, “none with an active oncological diagnosis was included.”
To investigate this issue, they launched the SARS-CoV-2 for Cancer Patients (SOAP-02) study.
The 151 patients with cancer who participated in this study were mostly elderly, the authors noted (75% were older than 65 years; the median age was 73 years). The majority (63%) had solid-tumor malignancies. Of those, 8% had late-stage disease and had been living with their cancer for more than 24 months.
The healthy control persons were vaccine-eligible primary health care workers who were not age matched to the cancer patients.
All participants received the first dose of vaccine; 31 (of 151) patients with cancer and 16 (of 54) healthy control persons received the second dose on day 21.
The remaining participants were scheduled to receive their second dose 12 weeks later (after the study ended), in line with the changes in the national guidelines.
The team reported that, approximately 21 days after receiving the first vaccine dose, the immune efficacy of the vaccine was estimated to be 97% among healthy control persons vs. 39% for patients with solid tumors and only 13% for those with hematologic malignancies (P < .0001 for both).
T-cell responses, as assessed via interferon-gamma and/or interleukin-2 production, were observed in 82% of healthy control persons, 71% of patients with solid tumors, and 50% of those with hematologic cancers.
Vaccine boosting at day 21 resulted in immune efficacy of 100% for healthy control persons and 95% for patients with solid tumors. In contrast, only 43% of those who did not receive the second dose were seropositive 2 weeks later.
Further analysis suggested that participants who did not have a serologic response were “spread evenly” across different cancer types, but the reduced responses were more frequent among patients who had received the vaccine within 15 days of cancer treatment, especially chemotherapy, and had undergone intensive treatments.
The SOAP study is sponsored by King’s College London and Guy’s and St. Thomas Trust Foundation NHS Trust. It is funded from grants from the KCL Charity, Cancer Research UK, and program grants from Breast Cancer Now. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The new findings, which are soon to be published as a preprint, cast doubt on the current U.K. policy of delaying the second dose of the vaccine.
Delaying the second dose can leave most patients with cancer wholly or partially unprotected, according to the researchers. Moreover, such a delay has implications for transmission of SARS-CoV-2 in the cancer patient’s environs as well as for the evolution of virus variants that could be of concern, the researchers concluded.
The data come from a British study that included 151 patients with cancer and 54 healthy control persons. All participants received the COVID-19 mRNA BNT162b2 vaccine (Pfizer-BioNTech).
This vaccine requires two doses. The first few participants in this study were given the second dose 21 days after they had received the first dose, but then national guidelines changed, and the remaining participants had to wait 12 weeks to receive their second dose.
The researchers reported that, among health controls, the immune efficacy of the first dose was very high (97% efficacious). By contrast, among patients with solid tumors, the immune efficacy of a single dose was strikingly low (39%), and it was even lower in patients with hematologic malignancies (13%).
The second dose of vaccine greatly and rapidly increased the immune efficacy in patients with solid tumors (95% within 2 weeks of receiving the second dose), the researchers added.
Too few patients with hematologic cancers had received the second dose before the study ended for clear conclusions to be drawn. Nevertheless, the available data suggest that 50% of patients with hematologic cancers who had received the booster at day 21 were seropositive at 5 weeks vs. only 8% of those who had not received the booster.
“Our data provide the first real-world evidence of immune efficacy following one dose of the Pfizer vaccine in immunocompromised patient populations [and] clearly show that the poor one-dose efficacy in cancer patients can be rescued with an early booster at day 21,” commented senior author Sheeba Irshad, MD, senior clinical lecturer, King’s College London.
“Based on our findings, we would recommend an urgent review of the vaccine strategy for clinically extremely vulnerable groups. Until then, it is important that cancer patients continue to observe all public health measures in place, such as social distancing and shielding when attending hospitals, even after vaccination,” Dr. Irshad added.
The paper, with first author Leticia Monin-Aldama, PhD, is scheduled to appear on the preprint server medRxiv. It has not undergone peer review. The paper was distributed to journalists, with comments from experts not involved in the study, by the UK Science Media Centre.
These data are “of immediate importance” to patients with cancer, commented Shoba Amarnath, PhD, Newcastle University research fellow, Laboratory of T-cell Regulation, Newcastle University Center for Cancer, Newcastle upon Tyne, England.
“These findings are consistent with our understanding. … We know that the immune system within cancer patients is compromised as compared to healthy controls,” Dr. Amarnath said. “The data in the study support the notion that, in solid cancer patients, a considerable delay in second dose will extend the period when cancer patients are at risk of SARS-CoV-2 infection.”
Although more data are required, “this study does raise the issue of whether patients with cancer, other diseases, or those undergoing therapies that affect the body’s immune response should be fast-tracked for their second vaccine dose,” commented Lawrence Young, PhD, professor of molecular oncology and director of the Warwick Cancer Research Center, University of Warwick, Coventry, England.
Stephen Evans, MSc, professor of pharmacoepidemiology, London School of Hygiene and Tropical Medicine, underlined that the study is “essentially” observational and “inevitable limitations must be taken into account.
“Nevertheless, these results do suggest that the vaccines may well not protect those patients with cancer as well as those without cancer,” Mr. Evans said. He added that it is “important that this population continues to observe all COVID-19–associated measures, such as social distancing and shielding when attending hospitals, even after vaccination.”
Study details
Previous studies have shown that some patients with cancer have prolonged responses to SARS-CoV-2 infection, with ongoing immune dysregulation, inefficient seroconversion, and prolonged viral shedding.
There are few data, however, on how these patients respond to COVID-19 vaccination. The authors point out that, among the 18,860 individuals who received the Pfizer vaccine during its development trials, “none with an active oncological diagnosis was included.”
To investigate this issue, they launched the SARS-CoV-2 for Cancer Patients (SOAP-02) study.
The 151 patients with cancer who participated in this study were mostly elderly, the authors noted (75% were older than 65 years; the median age was 73 years). The majority (63%) had solid-tumor malignancies. Of those, 8% had late-stage disease and had been living with their cancer for more than 24 months.
The healthy control persons were vaccine-eligible primary health care workers who were not age matched to the cancer patients.
All participants received the first dose of vaccine; 31 (of 151) patients with cancer and 16 (of 54) healthy control persons received the second dose on day 21.
The remaining participants were scheduled to receive their second dose 12 weeks later (after the study ended), in line with the changes in the national guidelines.
The team reported that, approximately 21 days after receiving the first vaccine dose, the immune efficacy of the vaccine was estimated to be 97% among healthy control persons vs. 39% for patients with solid tumors and only 13% for those with hematologic malignancies (P < .0001 for both).
T-cell responses, as assessed via interferon-gamma and/or interleukin-2 production, were observed in 82% of healthy control persons, 71% of patients with solid tumors, and 50% of those with hematologic cancers.
Vaccine boosting at day 21 resulted in immune efficacy of 100% for healthy control persons and 95% for patients with solid tumors. In contrast, only 43% of those who did not receive the second dose were seropositive 2 weeks later.
Further analysis suggested that participants who did not have a serologic response were “spread evenly” across different cancer types, but the reduced responses were more frequent among patients who had received the vaccine within 15 days of cancer treatment, especially chemotherapy, and had undergone intensive treatments.
The SOAP study is sponsored by King’s College London and Guy’s and St. Thomas Trust Foundation NHS Trust. It is funded from grants from the KCL Charity, Cancer Research UK, and program grants from Breast Cancer Now. The investigators have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.