User login
California Seeks Mental Health Warning Labels on Social Media
In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.
Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.
“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.
Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.
“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.
, a sponsor of AB 56, said in a press release.
Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”
If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.
The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”
“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.
Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.
In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.
Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.
In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.
‘A Broken Fire Alarm’
“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.
He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.
O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.
Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.
“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.
Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.
“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”
Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”
“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”
A version of this article first appeared on Medscape.com.
In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.
Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.
“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.
Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.
“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.
, a sponsor of AB 56, said in a press release.
Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”
If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.
The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”
“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.
Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.
In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.
Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.
In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.
‘A Broken Fire Alarm’
“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.
He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.
O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.
Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.
“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.
Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.
“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”
Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”
“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”
A version of this article first appeared on Medscape.com.
In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.
Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.
“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.
Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.
“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.
, a sponsor of AB 56, said in a press release.
Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”
If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.
The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”
“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.
Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.
In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.
Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.
In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.
‘A Broken Fire Alarm’
“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.
He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.
O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.
Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.
“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.
Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.
“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”
Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”
“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”
A version of this article first appeared on Medscape.com.
Novel Digital Intervention Shows Promise for Depression
TOPLINE:
InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.
METHODOLOGY:
- The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
- IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
- The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.
TAKEAWAY:
- The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
- The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
- The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
- Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).
IN PRACTICE:
“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.
SOURCE:
The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.
LIMITATIONS:
The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.
DISCLOSURES:
The investigators reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.
METHODOLOGY:
- The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
- IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
- The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.
TAKEAWAY:
- The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
- The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
- The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
- Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).
IN PRACTICE:
“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.
SOURCE:
The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.
LIMITATIONS:
The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.
DISCLOSURES:
The investigators reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
InterRhythmic care (IRC), a novel digital intervention, was linked to greater improvements in depressive symptoms, anxiety, interpersonal relationships, and social functioning in patients with major depressive disorder (MDD), compared with internet general psychoeducation in new research.
METHODOLOGY:
- The randomized, single-blind trial included 120 outpatients from the Shanghai Mental Health Center between March and November 2021 with MDD (mean age, 28.2 years; 99% Han Chinese; 83% women) who were randomly assigned to receive either IRC or internet general psychoeducation (control group).
- IRC included computer-based psychoeducation on stabilizing social rhythm regularity and resolution of interpersonal problems plus brief online interactions with clinicians. Patients received 10 minutes of IRC daily, Monday through Friday, for 8 weeks.
- The researchers assessed participants’ depressive symptoms, anxiety symptoms, interpersonal relationships, social function, and biological rhythms using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Interpersonal Comprehensive Diagnostic Scale, Sheehan Disability Scale, and Morning and Evening Questionnaire at baseline and at 8 weeks.
TAKEAWAY:
- The participants who received IRC had significantly lower Hamilton Depression Rating total scores than those who received internet general psychoeducation (P < .001).
- The IRC group demonstrated improved anxiety symptoms, as evidenced by lower Hamilton Anxiety Scale total scores, than those observed for the control group (P < .001).
- The IRC group also showed improved outcomes in interpersonal relationships, as indicated by lower Interpersonal Comprehensive Diagnostic Scale total scores (P < .001).
- Social functioning improved significantly in the IRC group, as measured by the Sheehan Disability Scale subscores for work/school (P = .03), social life (P < .001), and family life (P = .001).
IN PRACTICE:
“This study demonstrated that IRC can improve clinical symptoms such as depressive symptoms, anxiety symptoms, interpersonal problems, and social function in patients with MDD. Our study suggested that the IRC can be used in clinical practice,” the investigators wrote.
SOURCE:
The study was led by Chuchen Xu, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine in China. It was published online on November 20, 2024, in The Journal of Psychiatric Research.
LIMITATIONS:
The 8-week follow-up period was considered too short to comprehensively evaluate the intervention’s long-term impact. Additionally, the researchers had to check and supervise assignment completion, which increased research costs and may, therefore, potentially limit broader implementation.
DISCLOSURES:
The investigators reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
How Extreme Rainfall Amplifies Health Risks
Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.
Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
Extreme Rainfall and Health
The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.
The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
Rain and Mortality
Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.
The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.
The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
Points of Concern
According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:
- Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
- Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
- Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.
The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.
The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.
Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
Extreme Rainfall and Health
The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.
The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
Rain and Mortality
Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.
The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.
The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
Points of Concern
According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:
- Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
- Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
- Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.
The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.
The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Climate change is intensifying the variability of precipitation caused by extreme daily and overall rainfall events. Awareness of the effects of these events is crucial for understanding the complex health consequences of climate change. Physicians have often advised their patients to move to a better climate, and when they did, the recommendation was rarely based on precise scientific knowledge. However, the benefits of changing environments were often so evident that they were indisputable.
Today, advanced models, satellite imagery, and biological approaches such as environmental epigenetics are enhancing our understanding of health risks related to climate change.
Extreme Rainfall and Health
The increase in precipitation variability is linked to climate warming, which leads to higher atmospheric humidity and extreme rainfall events. These manifestations can cause rapid weather changes, increasing interactions with harmful aerosols and raising the risk for various cardiovascular and respiratory conditions. However, a full understanding of the association between rain and health has been hindered by conflicting results and methodological issues (limited geographical locations and short observation durations) in studies.
The association between rainfall intensity and health effects is likely nonlinear. Moderate precipitation can mitigate summer heat and help reduce air pollution, an effect that may lower some environmental health risks. Conversely, intense, low-frequency, short-duration rainfall events can have particularly harmful effects on health, as such events can trigger rapid weather changes, increased proliferation of pathogens, and a rise in the risk of various pollutants, potentially exacerbating health conditions.
Rain and Mortality
Using an intensity-duration-frequency model of three rainfall indices (high intensity, low frequency, short duration), a study published in October 2024 combined these with mortality data from 34 countries or regions. Researchers estimated associations between mortality (all cause, cardiovascular, and respiratory) and rainfall events with different return periods (the average time expected before an extreme event of a certain magnitude occurs again) and crucial effect modifiers, including climatic, socioeconomic, and urban environmental conditions.
The analysis included 109,954,744 deaths from all causes; 31,164,161 cardiovascular deaths; and 11,817,278 respiratory deaths. During the study period, from 1980 to 2020, a total of 50,913 rainfall events with a 1-year return period, 8362 events with a 2-year return period, and 3301 events with a 5-year return period were identified.
The most significant finding was a global positive association between all-cause mortality and extreme rainfall events with a 5-year return period. One day of extreme rainfall with a 5-year return period was associated with a cumulative relative risk (RRc) of 1.08 (95% CI, 1.05-1.11) for daily mortality from all causes. Rainfall events with a 2-year return period were associated with increased daily respiratory mortality (RRc, 1.14), while no significant effect was observed for cardiovascular mortality during the same period. Rainfall events with a 5-year return period were associated with an increased risk for both cardiovascular mortality (RRc, 1.05) and respiratory mortality (RRc, 1.29), with the respiratory mortality being significantly higher.
Points of Concern
According to the authors, moderate to high rainfall can exert protective effects through two main mechanisms: Improving air quality (rainfall can reduce the concentration of particulate matter 2.5 cm in diameter or less in the atmosphere) and behavioral changes in people (more time spent in enclosed environments, reducing direct exposure to outdoor air pollution and nonoptimal temperatures). As rainfall intensity increases, the initial protective effects may be overshadowed by a cascade of negative impacts including:
- Critical resource disruptions: Intense rainfall can cause severe disruptions to access to healthcare, infrastructure damage including power outages, and compromised water and food quality.
- Physiological effects: Increased humidity levels facilitate the growth of airborne pathogens, potentially triggering allergic reactions and respiratory issues, particularly in vulnerable individuals. Rapid shifts in atmospheric pressure and temperature fluctuations can lead to cardiovascular and respiratory complications.
- Indirect effects: Extreme rainfall can have profound effects on mental health, inducing stress and anxiety that may exacerbate pre-existing mental health conditions and indirectly contribute to increased overall mortality from nonexternal causes.
The intensity-response curves for the health effects of heavy rainfall showed a nonlinear trend, transitioning from a protective effect at moderate levels of rainfall to a risk for severe harm when rainfall intensity became extreme. Additionally, the significant effects of extreme events were modified by various types of climate and were more pronounced in areas characterized by low variability in precipitation or sparse vegetation cover.
The study demonstrated that various local factors, such as climatic conditions, climate type, and vegetation cover, can potentially influence cardiovascular and respiratory mortality and all-cause mortality related to precipitation. The findings may help physicians convey to their patients the impact of climate change on their health.
This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Duloxetine Bottles Recalled by FDA Because of Potential Carcinogen
The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.
Duloxetine (Cymbalta) is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy.
The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.
Nitrosamines are common in water and foods, and exposure to some levels of the chemical is common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.
“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website.
The recall was initiated by Breckenridge Pharmaceutical and covers 7107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI.
The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.
The recall was initiated on October 10 and is ongoing.
“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled. Prescribers may also determine whether there is an alternative treatment option for patients.”
The FDA has labeled this a “class II” recall, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.
The impurities may be found in drugs for a number of reasons, the agency reported. The source may be from a drug’s manufacturing process, chemical structure, or the conditions under which it is stored or packaged.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.
Duloxetine (Cymbalta) is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy.
The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.
Nitrosamines are common in water and foods, and exposure to some levels of the chemical is common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.
“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website.
The recall was initiated by Breckenridge Pharmaceutical and covers 7107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI.
The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.
The recall was initiated on October 10 and is ongoing.
“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled. Prescribers may also determine whether there is an alternative treatment option for patients.”
The FDA has labeled this a “class II” recall, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.
The impurities may be found in drugs for a number of reasons, the agency reported. The source may be from a drug’s manufacturing process, chemical structure, or the conditions under which it is stored or packaged.
A version of this article appeared on Medscape.com.
The US Food and Drug Administration (FDA) has announced a voluntary manufacturer-initiated recall of more than 7000 bottles of duloxetine delayed-release capsules due to unacceptable levels of a potential carcinogen.
Duloxetine (Cymbalta) is a serotonin-norepinephrine reuptake inhibitor used to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, chronic musculoskeletal pain, and neuropathic pain associated with diabetic peripheral neuropathy.
The recall is due to the detection of the nitrosamine impurity, N-nitroso duloxetine, above the proposed interim limit.
Nitrosamines are common in water and foods, and exposure to some levels of the chemical is common. Exposure to nitrosamine impurities above acceptable levels and over long periods may increase cancer risk, the FDA reported.
“If drugs contain levels of nitrosamines above the acceptable daily intake limits, FDA recommends these drugs be recalled by the manufacturer as appropriate,” the agency noted on its website.
The recall was initiated by Breckenridge Pharmaceutical and covers 7107 bottles of 500-count, 20 mg duloxetine delayed-release capsules. The drug is manufactured by Towa Pharmaceutical Europe and distributed nationwide by BPI.
The affected bottles are from lot number 220128 with an expiration date of 12/2024 and NDC of 51991-746-05.
The recall was initiated on October 10 and is ongoing.
“Healthcare professionals can educate patients about alternative treatment options to medications with potential nitrosamine impurities if available and clinically appropriate,” the FDA advises. “If a medication has been recalled, pharmacists may be able to dispense the same medication from a manufacturing lot that has not been recalled. Prescribers may also determine whether there is an alternative treatment option for patients.”
The FDA has labeled this a “class II” recall, which the agency defines as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Nitrosamine impurities have prompted a number of drug recalls in recent years, including oral anticoagulants, metformin, and skeletal muscle relaxants.
The impurities may be found in drugs for a number of reasons, the agency reported. The source may be from a drug’s manufacturing process, chemical structure, or the conditions under which it is stored or packaged.
A version of this article appeared on Medscape.com.
Suicide Screening and Safety Plans Moved Needle on Attempts and Deaths Moving the Needle
In the winter of 2023, Cynthia Smith, MD, an internal medicine physician in Philadelphia and the chief membership and engagement officer for the American College of Physicians, treated a high-achieving, middle-aged man who said he felt completely alone and isolated.
Smith used depression and suicide screeners and found the man was actively thinking of harming himself. She and the man created a safety plan. Then, she connected her patient to a clinical social worker within her health system who helped him enter an intensive outpatient treatment program for depression.
“I am not sure if screening this patient for depression saved his life, but I do think he left the office feeling less alone and more supported than when he arrived. Screening him helped us achieve that outcome,” said Smith. “Our patient needed to know that we cared about him.”
Smith’s experience is part of a broader movement to screen patients for depression and suicide with the goal of getting people into treatment.
Prior research has shown more than 40% people who die by suicide visit a primary care clinician in the month before death, and more than 75% see a primary care physician in the year before a suicide death.
New research published in Annals of Internal Medicine showed these screening processes reduced suicide attempts and deaths by suicide by 25% in one health system.
Clinicians using screening questions to engage patients in safety planning “can know that this work is valuable, and that it will save lives,” said Julie Angerhofer, PhD, MPH, a collaborative scientist at Kaiser Permanente Washington Health Research Institute in Seattle, and a coauthor of the study. “For those who are considering investing in doing this work, it is good news because it is going to have an effect. We did not know that until we did this trial.”
Suicide is the 11th leading cause of death in the United States, accounting for 49,000 fatalities in 2022, according to the Centers for Disease Control and Prevention.
The new study findings “are significant when it comes to working with people who are at risk for suicide in primary care practice and shows that it is both feasible and effective,” said Julie Goldstein Grumet, PhD, vice president for suicide prevention strategy and director of the Zero Suicide Institute at the nonprofit Education Development Center.
Grumet said the use of standardized screening tools, like those used in the study protocol, is key.
When patients screened positive for depression with the Patient Health Questionnaire 2 (PHQ-2), they were asked to complete the additional questions of the PHQ-9. If patients reported frequent suicidal thoughts, they received a brief, self-administered version of the Columbia-Suicide Severity Rating Scale. The analysis included 333,593 patients who had 1.56 million visits for any reason to their primary care clinician.
Patients who reported some level of intent or planning for a suicide attempt in the prior month were connected to a clinical social worker for same day safety planning.
The study showed that the rate of documented fatal or nonfatal suicide attempts within 90 days of a primary care visit was 25% lower in the suicide care than in the usual care period and 24% lower in the 60 days after a visit, both statistically significant findings.
These tools help clinicians “to determine the type of care needed and to provide the right level of intervention,” Grumet said.
Both Smith and the study utilized social workers to help with safety planning. But because many clinicians do not work in integrated health systems with access to these professionals, other workflows can also support the screening and safety planning process, Angerhofer said. For instance, nurses can be trained to conduct a safety plan.
“Some systems also use centralized groups of providers trained in safety planning to support primary care teams virtually,” she said. Clinicians can also refer to free trainings on safety planning available online — including the one on the Zero Suicide website.
Smith said one of the biggest barriers to suicide care is the lack of resources needed to follow-up on a positive screen.
The study findings are “a call to action, but it can’t be the straw breaking the backs of primary care doctors; it has to be supported,” Smith said.
A safety plan includes:
- Helping patients recognize warning signs of an impending suicidal crisis
- Using social contacts as a means of distraction from suicidal thoughts
- Contacting family members or friends who may help resolve the crisis
- Contacting mental health professionals or agencies
- Making the patient’s home environment safer by reducing the potential use and availability of lethal means
The study was supported by a grant from the National Institute of Mental Health. Various study authors reported receiving consulting fees, honoraria, and grants from the University of Washington, Advocate Aurora Health, the Donaghue Medical Research Foundation’s Greater Value Portfolio program, and the Patient-Centered Outcomes Research Institute, among others.
A version of this article first appeared on Medscape.com.
In the winter of 2023, Cynthia Smith, MD, an internal medicine physician in Philadelphia and the chief membership and engagement officer for the American College of Physicians, treated a high-achieving, middle-aged man who said he felt completely alone and isolated.
Smith used depression and suicide screeners and found the man was actively thinking of harming himself. She and the man created a safety plan. Then, she connected her patient to a clinical social worker within her health system who helped him enter an intensive outpatient treatment program for depression.
“I am not sure if screening this patient for depression saved his life, but I do think he left the office feeling less alone and more supported than when he arrived. Screening him helped us achieve that outcome,” said Smith. “Our patient needed to know that we cared about him.”
Smith’s experience is part of a broader movement to screen patients for depression and suicide with the goal of getting people into treatment.
Prior research has shown more than 40% people who die by suicide visit a primary care clinician in the month before death, and more than 75% see a primary care physician in the year before a suicide death.
New research published in Annals of Internal Medicine showed these screening processes reduced suicide attempts and deaths by suicide by 25% in one health system.
Clinicians using screening questions to engage patients in safety planning “can know that this work is valuable, and that it will save lives,” said Julie Angerhofer, PhD, MPH, a collaborative scientist at Kaiser Permanente Washington Health Research Institute in Seattle, and a coauthor of the study. “For those who are considering investing in doing this work, it is good news because it is going to have an effect. We did not know that until we did this trial.”
Suicide is the 11th leading cause of death in the United States, accounting for 49,000 fatalities in 2022, according to the Centers for Disease Control and Prevention.
The new study findings “are significant when it comes to working with people who are at risk for suicide in primary care practice and shows that it is both feasible and effective,” said Julie Goldstein Grumet, PhD, vice president for suicide prevention strategy and director of the Zero Suicide Institute at the nonprofit Education Development Center.
Grumet said the use of standardized screening tools, like those used in the study protocol, is key.
When patients screened positive for depression with the Patient Health Questionnaire 2 (PHQ-2), they were asked to complete the additional questions of the PHQ-9. If patients reported frequent suicidal thoughts, they received a brief, self-administered version of the Columbia-Suicide Severity Rating Scale. The analysis included 333,593 patients who had 1.56 million visits for any reason to their primary care clinician.
Patients who reported some level of intent or planning for a suicide attempt in the prior month were connected to a clinical social worker for same day safety planning.
The study showed that the rate of documented fatal or nonfatal suicide attempts within 90 days of a primary care visit was 25% lower in the suicide care than in the usual care period and 24% lower in the 60 days after a visit, both statistically significant findings.
These tools help clinicians “to determine the type of care needed and to provide the right level of intervention,” Grumet said.
Both Smith and the study utilized social workers to help with safety planning. But because many clinicians do not work in integrated health systems with access to these professionals, other workflows can also support the screening and safety planning process, Angerhofer said. For instance, nurses can be trained to conduct a safety plan.
“Some systems also use centralized groups of providers trained in safety planning to support primary care teams virtually,” she said. Clinicians can also refer to free trainings on safety planning available online — including the one on the Zero Suicide website.
Smith said one of the biggest barriers to suicide care is the lack of resources needed to follow-up on a positive screen.
The study findings are “a call to action, but it can’t be the straw breaking the backs of primary care doctors; it has to be supported,” Smith said.
A safety plan includes:
- Helping patients recognize warning signs of an impending suicidal crisis
- Using social contacts as a means of distraction from suicidal thoughts
- Contacting family members or friends who may help resolve the crisis
- Contacting mental health professionals or agencies
- Making the patient’s home environment safer by reducing the potential use and availability of lethal means
The study was supported by a grant from the National Institute of Mental Health. Various study authors reported receiving consulting fees, honoraria, and grants from the University of Washington, Advocate Aurora Health, the Donaghue Medical Research Foundation’s Greater Value Portfolio program, and the Patient-Centered Outcomes Research Institute, among others.
A version of this article first appeared on Medscape.com.
In the winter of 2023, Cynthia Smith, MD, an internal medicine physician in Philadelphia and the chief membership and engagement officer for the American College of Physicians, treated a high-achieving, middle-aged man who said he felt completely alone and isolated.
Smith used depression and suicide screeners and found the man was actively thinking of harming himself. She and the man created a safety plan. Then, she connected her patient to a clinical social worker within her health system who helped him enter an intensive outpatient treatment program for depression.
“I am not sure if screening this patient for depression saved his life, but I do think he left the office feeling less alone and more supported than when he arrived. Screening him helped us achieve that outcome,” said Smith. “Our patient needed to know that we cared about him.”
Smith’s experience is part of a broader movement to screen patients for depression and suicide with the goal of getting people into treatment.
Prior research has shown more than 40% people who die by suicide visit a primary care clinician in the month before death, and more than 75% see a primary care physician in the year before a suicide death.
New research published in Annals of Internal Medicine showed these screening processes reduced suicide attempts and deaths by suicide by 25% in one health system.
Clinicians using screening questions to engage patients in safety planning “can know that this work is valuable, and that it will save lives,” said Julie Angerhofer, PhD, MPH, a collaborative scientist at Kaiser Permanente Washington Health Research Institute in Seattle, and a coauthor of the study. “For those who are considering investing in doing this work, it is good news because it is going to have an effect. We did not know that until we did this trial.”
Suicide is the 11th leading cause of death in the United States, accounting for 49,000 fatalities in 2022, according to the Centers for Disease Control and Prevention.
The new study findings “are significant when it comes to working with people who are at risk for suicide in primary care practice and shows that it is both feasible and effective,” said Julie Goldstein Grumet, PhD, vice president for suicide prevention strategy and director of the Zero Suicide Institute at the nonprofit Education Development Center.
Grumet said the use of standardized screening tools, like those used in the study protocol, is key.
When patients screened positive for depression with the Patient Health Questionnaire 2 (PHQ-2), they were asked to complete the additional questions of the PHQ-9. If patients reported frequent suicidal thoughts, they received a brief, self-administered version of the Columbia-Suicide Severity Rating Scale. The analysis included 333,593 patients who had 1.56 million visits for any reason to their primary care clinician.
Patients who reported some level of intent or planning for a suicide attempt in the prior month were connected to a clinical social worker for same day safety planning.
The study showed that the rate of documented fatal or nonfatal suicide attempts within 90 days of a primary care visit was 25% lower in the suicide care than in the usual care period and 24% lower in the 60 days after a visit, both statistically significant findings.
These tools help clinicians “to determine the type of care needed and to provide the right level of intervention,” Grumet said.
Both Smith and the study utilized social workers to help with safety planning. But because many clinicians do not work in integrated health systems with access to these professionals, other workflows can also support the screening and safety planning process, Angerhofer said. For instance, nurses can be trained to conduct a safety plan.
“Some systems also use centralized groups of providers trained in safety planning to support primary care teams virtually,” she said. Clinicians can also refer to free trainings on safety planning available online — including the one on the Zero Suicide website.
Smith said one of the biggest barriers to suicide care is the lack of resources needed to follow-up on a positive screen.
The study findings are “a call to action, but it can’t be the straw breaking the backs of primary care doctors; it has to be supported,” Smith said.
A safety plan includes:
- Helping patients recognize warning signs of an impending suicidal crisis
- Using social contacts as a means of distraction from suicidal thoughts
- Contacting family members or friends who may help resolve the crisis
- Contacting mental health professionals or agencies
- Making the patient’s home environment safer by reducing the potential use and availability of lethal means
The study was supported by a grant from the National Institute of Mental Health. Various study authors reported receiving consulting fees, honoraria, and grants from the University of Washington, Advocate Aurora Health, the Donaghue Medical Research Foundation’s Greater Value Portfolio program, and the Patient-Centered Outcomes Research Institute, among others.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
New Treatment Effective for Male Postpartum Depression
A psychosocial intervention designed to improve depressive symptoms and promote good parenting skills can be an effective way of treating male postpartum depression, according to new research.
In a study conducted in Pakistan, about 70% fathers with postpartum depression who received the intervention showed complete remission of their depressive symptoms and experienced enhanced relationships with their children and domestic partners.
Called Learning Through Play Plus Dads (LTP + Dads), the intervention, which can be delivered by community health workers, could improve paternal mental health and child development not only in Pakistan but also in other populations, the authors stated.
The results of the study were published on October 2, 2024, in JAMA Psychiatry.
Stigmatized and Understudied
“Pakistan is a patriarchal society with strict gender roles, and male mental health, particularly postpartum depression in new fathers, is stigmatized and understudied,” lead investigator Ishrat Husain, MD, a senior scientist at the Centre for Addiction and Mental Health and associate professor of psychiatry at the University of Toronto in Ontario, Canada, said in an interview.
“Historically, and rightly so, the focus has always been on the mother, but men also experience significant emotional challenges as they adapt to being a parent. Fathers are also in need of support,” said Husain.
Male postpartum depression is prevalent in all populations. Globally, about 10% fathers have postpartum depression. But in societies like Pakistan, rates of male postpartum depression have been reported to be as high as 23.5%.
The study included 357 fathers aged 18 years or older (mean age, 31.44 years) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of major depressive episode and a child younger than 30 months.
They were randomly assigned either to receive treatment as usual (n = 186) or to participate in the LTP + Dads program (n = 171). LTP + Dads is a parenting and mental health initiative adapted from a similar program for Pakistani mothers. It combines parenting skills training, play therapy, and cognitive behavioral therapy. In this study, the initiative was delivered by community health workers in 12 group sessions over 4 months. Sessions took place weekly for the first 2 months and biweekly thereafter.
The researchers assessed changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) score at 4 months and at 6 months. They also looked at anxiety symptoms; parenting stress; intimate partner violence; functioning; quality of life; and child social, emotional, and physical health outcomes.
Improved Child Development
There were significantly greater reductions in HDRS-17 scores in the LTP + Dads group than in the treatment as usual group at 4 months (group difference ratio [GDR], 0.66; P < .001) and at 6 months (GDR, 0.67; P < .001).
Similar results were seen for anxiety (GDR, 0.62; P < .001), parenting stress (GDR, −12.5; P < .001), intimate partner violence (GDR, 0.89; P = .05), disability (GDR, 0.77; P = .03), and health-related quality of life (GDR, 12.7; P < .001) at 4 months. The differences in depression and parenting stress were sustained at 6 months.
In addition, children of fathers who received the parenting intervention showed significantly greater improvements in social-emotional development scores (mean difference, −20.8; P < .001) at 6 months than children of those who received the treatment as usual.
“We believe that this program could also be successful in other countries, including Canada,” said Husain. “Canada is multicultural, and similar patterns of male postpartum depression probably exist here. We know that cultural and social pressures create barriers to seeking mental health support for men. Stigma and cultural beliefs often prevent new fathers from seeking the help they need. Programs like LTP + Dads can help men transition to their new role as fathers by giving them support to process their emotions,” he said.
Husain added that the program will be expanded throughout Pakistan to include about 4000 fathers and their partners.
‘Remarkable’ Success Rate
“Postpartum depression in men is still something that people are trying to understand,” John Ogrodniczuk, MD, professor of psychiatry and director of the psychotherapy program at The University of British Columbia, Vancouver, Canada, said in an interview. He did not participate in the study.
“Obviously, men aren’t going through the same endocrine changes that women are, but nonetheless, a lot of men do actually struggle with it,” said Ogrodniczuk, who is also the founder of HeadsUpGuys, a mental health resource for men.
“Understandably, most of the literature is around postpartum depression in women, not so much around men. The positive results seen here are interesting, especially in a country that is patriarchal and where there is not a lot of uptake of mental health interventions and services by men,” he said.
“The success rate of this psychosocial intervention is remarkable, so I am excited to see that the researchers have secured funding to expand the study and validate their results with a larger group of participants,” Simon B. Sherry, PhD, professor of psychology and neuroscience at Dalhousie University, Halifax, Nova Scotia, Canada, said in an interview.
“I am also encouraged by the inclusion of play-based activities in addition to cognitive behavioral therapy. Perhaps more than any other role we hold through life, the role of parent comes with copious societal and personal expectations, plus with all that pressure, transitioning into that role is hard for everyone, but especially for those with postpartum depression. Supporting parents and improving their mental well-being goes a long way toward raising mentally healthy kids,” said Sherry, who was not part of the study.
The study was funded by a grant from Grand Challenges Canada, an Academic Scholars Award from the Department of Psychiatry at the University of Toronto, and a Tier 2 Canada Research Chair from the Canadian Institutes of Health Research. Husain reported receiving grants from COMPASS Pathfinder, stock options from Mindset Pharma, and personal fees from Wake Network, outside the submitted work. He previously served as a trustee for the Pakistan Institute of Living and Learning. Ogrodniczuk and Sherry reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A psychosocial intervention designed to improve depressive symptoms and promote good parenting skills can be an effective way of treating male postpartum depression, according to new research.
In a study conducted in Pakistan, about 70% fathers with postpartum depression who received the intervention showed complete remission of their depressive symptoms and experienced enhanced relationships with their children and domestic partners.
Called Learning Through Play Plus Dads (LTP + Dads), the intervention, which can be delivered by community health workers, could improve paternal mental health and child development not only in Pakistan but also in other populations, the authors stated.
The results of the study were published on October 2, 2024, in JAMA Psychiatry.
Stigmatized and Understudied
“Pakistan is a patriarchal society with strict gender roles, and male mental health, particularly postpartum depression in new fathers, is stigmatized and understudied,” lead investigator Ishrat Husain, MD, a senior scientist at the Centre for Addiction and Mental Health and associate professor of psychiatry at the University of Toronto in Ontario, Canada, said in an interview.
“Historically, and rightly so, the focus has always been on the mother, but men also experience significant emotional challenges as they adapt to being a parent. Fathers are also in need of support,” said Husain.
Male postpartum depression is prevalent in all populations. Globally, about 10% fathers have postpartum depression. But in societies like Pakistan, rates of male postpartum depression have been reported to be as high as 23.5%.
The study included 357 fathers aged 18 years or older (mean age, 31.44 years) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of major depressive episode and a child younger than 30 months.
They were randomly assigned either to receive treatment as usual (n = 186) or to participate in the LTP + Dads program (n = 171). LTP + Dads is a parenting and mental health initiative adapted from a similar program for Pakistani mothers. It combines parenting skills training, play therapy, and cognitive behavioral therapy. In this study, the initiative was delivered by community health workers in 12 group sessions over 4 months. Sessions took place weekly for the first 2 months and biweekly thereafter.
The researchers assessed changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) score at 4 months and at 6 months. They also looked at anxiety symptoms; parenting stress; intimate partner violence; functioning; quality of life; and child social, emotional, and physical health outcomes.
Improved Child Development
There were significantly greater reductions in HDRS-17 scores in the LTP + Dads group than in the treatment as usual group at 4 months (group difference ratio [GDR], 0.66; P < .001) and at 6 months (GDR, 0.67; P < .001).
Similar results were seen for anxiety (GDR, 0.62; P < .001), parenting stress (GDR, −12.5; P < .001), intimate partner violence (GDR, 0.89; P = .05), disability (GDR, 0.77; P = .03), and health-related quality of life (GDR, 12.7; P < .001) at 4 months. The differences in depression and parenting stress were sustained at 6 months.
In addition, children of fathers who received the parenting intervention showed significantly greater improvements in social-emotional development scores (mean difference, −20.8; P < .001) at 6 months than children of those who received the treatment as usual.
“We believe that this program could also be successful in other countries, including Canada,” said Husain. “Canada is multicultural, and similar patterns of male postpartum depression probably exist here. We know that cultural and social pressures create barriers to seeking mental health support for men. Stigma and cultural beliefs often prevent new fathers from seeking the help they need. Programs like LTP + Dads can help men transition to their new role as fathers by giving them support to process their emotions,” he said.
Husain added that the program will be expanded throughout Pakistan to include about 4000 fathers and their partners.
‘Remarkable’ Success Rate
“Postpartum depression in men is still something that people are trying to understand,” John Ogrodniczuk, MD, professor of psychiatry and director of the psychotherapy program at The University of British Columbia, Vancouver, Canada, said in an interview. He did not participate in the study.
“Obviously, men aren’t going through the same endocrine changes that women are, but nonetheless, a lot of men do actually struggle with it,” said Ogrodniczuk, who is also the founder of HeadsUpGuys, a mental health resource for men.
“Understandably, most of the literature is around postpartum depression in women, not so much around men. The positive results seen here are interesting, especially in a country that is patriarchal and where there is not a lot of uptake of mental health interventions and services by men,” he said.
“The success rate of this psychosocial intervention is remarkable, so I am excited to see that the researchers have secured funding to expand the study and validate their results with a larger group of participants,” Simon B. Sherry, PhD, professor of psychology and neuroscience at Dalhousie University, Halifax, Nova Scotia, Canada, said in an interview.
“I am also encouraged by the inclusion of play-based activities in addition to cognitive behavioral therapy. Perhaps more than any other role we hold through life, the role of parent comes with copious societal and personal expectations, plus with all that pressure, transitioning into that role is hard for everyone, but especially for those with postpartum depression. Supporting parents and improving their mental well-being goes a long way toward raising mentally healthy kids,” said Sherry, who was not part of the study.
The study was funded by a grant from Grand Challenges Canada, an Academic Scholars Award from the Department of Psychiatry at the University of Toronto, and a Tier 2 Canada Research Chair from the Canadian Institutes of Health Research. Husain reported receiving grants from COMPASS Pathfinder, stock options from Mindset Pharma, and personal fees from Wake Network, outside the submitted work. He previously served as a trustee for the Pakistan Institute of Living and Learning. Ogrodniczuk and Sherry reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A psychosocial intervention designed to improve depressive symptoms and promote good parenting skills can be an effective way of treating male postpartum depression, according to new research.
In a study conducted in Pakistan, about 70% fathers with postpartum depression who received the intervention showed complete remission of their depressive symptoms and experienced enhanced relationships with their children and domestic partners.
Called Learning Through Play Plus Dads (LTP + Dads), the intervention, which can be delivered by community health workers, could improve paternal mental health and child development not only in Pakistan but also in other populations, the authors stated.
The results of the study were published on October 2, 2024, in JAMA Psychiatry.
Stigmatized and Understudied
“Pakistan is a patriarchal society with strict gender roles, and male mental health, particularly postpartum depression in new fathers, is stigmatized and understudied,” lead investigator Ishrat Husain, MD, a senior scientist at the Centre for Addiction and Mental Health and associate professor of psychiatry at the University of Toronto in Ontario, Canada, said in an interview.
“Historically, and rightly so, the focus has always been on the mother, but men also experience significant emotional challenges as they adapt to being a parent. Fathers are also in need of support,” said Husain.
Male postpartum depression is prevalent in all populations. Globally, about 10% fathers have postpartum depression. But in societies like Pakistan, rates of male postpartum depression have been reported to be as high as 23.5%.
The study included 357 fathers aged 18 years or older (mean age, 31.44 years) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, diagnosis of major depressive episode and a child younger than 30 months.
They were randomly assigned either to receive treatment as usual (n = 186) or to participate in the LTP + Dads program (n = 171). LTP + Dads is a parenting and mental health initiative adapted from a similar program for Pakistani mothers. It combines parenting skills training, play therapy, and cognitive behavioral therapy. In this study, the initiative was delivered by community health workers in 12 group sessions over 4 months. Sessions took place weekly for the first 2 months and biweekly thereafter.
The researchers assessed changes in the 17-item Hamilton Depression Rating Scale (HDRS-17) score at 4 months and at 6 months. They also looked at anxiety symptoms; parenting stress; intimate partner violence; functioning; quality of life; and child social, emotional, and physical health outcomes.
Improved Child Development
There were significantly greater reductions in HDRS-17 scores in the LTP + Dads group than in the treatment as usual group at 4 months (group difference ratio [GDR], 0.66; P < .001) and at 6 months (GDR, 0.67; P < .001).
Similar results were seen for anxiety (GDR, 0.62; P < .001), parenting stress (GDR, −12.5; P < .001), intimate partner violence (GDR, 0.89; P = .05), disability (GDR, 0.77; P = .03), and health-related quality of life (GDR, 12.7; P < .001) at 4 months. The differences in depression and parenting stress were sustained at 6 months.
In addition, children of fathers who received the parenting intervention showed significantly greater improvements in social-emotional development scores (mean difference, −20.8; P < .001) at 6 months than children of those who received the treatment as usual.
“We believe that this program could also be successful in other countries, including Canada,” said Husain. “Canada is multicultural, and similar patterns of male postpartum depression probably exist here. We know that cultural and social pressures create barriers to seeking mental health support for men. Stigma and cultural beliefs often prevent new fathers from seeking the help they need. Programs like LTP + Dads can help men transition to their new role as fathers by giving them support to process their emotions,” he said.
Husain added that the program will be expanded throughout Pakistan to include about 4000 fathers and their partners.
‘Remarkable’ Success Rate
“Postpartum depression in men is still something that people are trying to understand,” John Ogrodniczuk, MD, professor of psychiatry and director of the psychotherapy program at The University of British Columbia, Vancouver, Canada, said in an interview. He did not participate in the study.
“Obviously, men aren’t going through the same endocrine changes that women are, but nonetheless, a lot of men do actually struggle with it,” said Ogrodniczuk, who is also the founder of HeadsUpGuys, a mental health resource for men.
“Understandably, most of the literature is around postpartum depression in women, not so much around men. The positive results seen here are interesting, especially in a country that is patriarchal and where there is not a lot of uptake of mental health interventions and services by men,” he said.
“The success rate of this psychosocial intervention is remarkable, so I am excited to see that the researchers have secured funding to expand the study and validate their results with a larger group of participants,” Simon B. Sherry, PhD, professor of psychology and neuroscience at Dalhousie University, Halifax, Nova Scotia, Canada, said in an interview.
“I am also encouraged by the inclusion of play-based activities in addition to cognitive behavioral therapy. Perhaps more than any other role we hold through life, the role of parent comes with copious societal and personal expectations, plus with all that pressure, transitioning into that role is hard for everyone, but especially for those with postpartum depression. Supporting parents and improving their mental well-being goes a long way toward raising mentally healthy kids,” said Sherry, who was not part of the study.
The study was funded by a grant from Grand Challenges Canada, an Academic Scholars Award from the Department of Psychiatry at the University of Toronto, and a Tier 2 Canada Research Chair from the Canadian Institutes of Health Research. Husain reported receiving grants from COMPASS Pathfinder, stock options from Mindset Pharma, and personal fees from Wake Network, outside the submitted work. He previously served as a trustee for the Pakistan Institute of Living and Learning. Ogrodniczuk and Sherry reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Heightened Amygdala Activity Tied to Postpartum Depression
MILAN, ITALY — Pregnant women with heightened amygdala activity have a reduced capacity to regulate emotions and report more symptoms of depression than those with lower activity in this brain region, a new imaging study suggested.
If validated, these findings could pave the way for identifying women at higher risk for postpartum depression, said lead researcher Franziska Weinmar, MSc, from the University of Tübingen in Germany.
The study was presented at the 37th European College of Neuropsychopharmacology Congress.
Differences in Brain Activity
During pregnancy and the peripartum period, rising hormone levels create a “psychoneuroendocrinological window of vulnerability” for mental health in which 80% of women can develop transitory “baby blues,” and about one in seven develop more serious postpartum depression, Ms. Weinmar told this news organization.
The study included 47 women — 15 pregnant women and 32 nonpregnant controls. The nonpregnant women had normal menstrual cycles; 16 were in the early follicular phase with low estradiol levels (231.7 pmol/L), and 16 had high estradiol levels (516.6 pmol/L) after administration of estradiol.
To examine brain activity, participants were asked to view negative emotional images while undergoing functional MRI. They were then asked to use cognitive reappraisal to regulate their emotional response to the images.
The findings showed that both pregnant and nonpregnant women were equally successful at emotional regulation, but this process involved different brain activity in pregnant vs their nonpregnant counterpart.
All women had increased left middle frontal gyrus activity when regulating their emotions, but there was a difference in the amygdala between the pregnancy group and controls, Ms. Weinmar noted.
This suggests that pregnant women may have to exert more neural effort in emotional regulation, she said. “And pregnant women with higher amygdala activity were less able to regulate their emotions successfully compared to those with less amygdala activity.”
Linear regression analyses were performed to assess the relation of brain activity during down-regulation, regulation success, and self-reported depression scores, and this showed that higher amygdala activity was also associated with higher depression scores.
“We need to be cautious in interpreting this,” said Ms. Weinmar. “This is a small sample, and we are the first to undertake this work.”
Nonetheless, she said that if the findings are confirmed by larger studies, pregnant women could be assessed “in the waiting room” using existing questionnaires that evaluate emotional regulation.
If a woman has difficulties with emotion regulation, “there are adaptive strategies, like cognitive reappraisal that a counseling psychotherapist can help with,” said Ms. Weinmar.
“I could also imagine group sessions, for example, or online courses,” she said, adding that obstetricians could also be trained to identify these women.
Commenting on the findings in a press release, Susana Carmona, PhD, from Gregorio Marañón Hospital in Madrid, Spain, said research like this is crucial for gaining insight into one of the most intense physiological processes a human can undergo: pregnancy. It’s remarkable how much remains unknown.
“Recently, the FDA [Food and Drug Administration] approved the first treatment for postpartum depression. However, we still have a long way to go in characterizing what happens in the brain during pregnancy, identifying biomarkers that can indicate the risk of developing perinatal mental disorders, and designing strategies to prevent mother and infant suffering during the delicate and critical peripartum period,” Dr. Carmona added.
The study was supported by the Center for Integrative Neuroscience in Tübingen, Germany, and the International Research Training Group “Women’s Mental Health Across the Reproductive Years” (IRTG 2804). Ms. Weinmar and Dr. Carmona reported no relevant disclosures.
A version of this article appeared on Medscape.com.
MILAN, ITALY — Pregnant women with heightened amygdala activity have a reduced capacity to regulate emotions and report more symptoms of depression than those with lower activity in this brain region, a new imaging study suggested.
If validated, these findings could pave the way for identifying women at higher risk for postpartum depression, said lead researcher Franziska Weinmar, MSc, from the University of Tübingen in Germany.
The study was presented at the 37th European College of Neuropsychopharmacology Congress.
Differences in Brain Activity
During pregnancy and the peripartum period, rising hormone levels create a “psychoneuroendocrinological window of vulnerability” for mental health in which 80% of women can develop transitory “baby blues,” and about one in seven develop more serious postpartum depression, Ms. Weinmar told this news organization.
The study included 47 women — 15 pregnant women and 32 nonpregnant controls. The nonpregnant women had normal menstrual cycles; 16 were in the early follicular phase with low estradiol levels (231.7 pmol/L), and 16 had high estradiol levels (516.6 pmol/L) after administration of estradiol.
To examine brain activity, participants were asked to view negative emotional images while undergoing functional MRI. They were then asked to use cognitive reappraisal to regulate their emotional response to the images.
The findings showed that both pregnant and nonpregnant women were equally successful at emotional regulation, but this process involved different brain activity in pregnant vs their nonpregnant counterpart.
All women had increased left middle frontal gyrus activity when regulating their emotions, but there was a difference in the amygdala between the pregnancy group and controls, Ms. Weinmar noted.
This suggests that pregnant women may have to exert more neural effort in emotional regulation, she said. “And pregnant women with higher amygdala activity were less able to regulate their emotions successfully compared to those with less amygdala activity.”
Linear regression analyses were performed to assess the relation of brain activity during down-regulation, regulation success, and self-reported depression scores, and this showed that higher amygdala activity was also associated with higher depression scores.
“We need to be cautious in interpreting this,” said Ms. Weinmar. “This is a small sample, and we are the first to undertake this work.”
Nonetheless, she said that if the findings are confirmed by larger studies, pregnant women could be assessed “in the waiting room” using existing questionnaires that evaluate emotional regulation.
If a woman has difficulties with emotion regulation, “there are adaptive strategies, like cognitive reappraisal that a counseling psychotherapist can help with,” said Ms. Weinmar.
“I could also imagine group sessions, for example, or online courses,” she said, adding that obstetricians could also be trained to identify these women.
Commenting on the findings in a press release, Susana Carmona, PhD, from Gregorio Marañón Hospital in Madrid, Spain, said research like this is crucial for gaining insight into one of the most intense physiological processes a human can undergo: pregnancy. It’s remarkable how much remains unknown.
“Recently, the FDA [Food and Drug Administration] approved the first treatment for postpartum depression. However, we still have a long way to go in characterizing what happens in the brain during pregnancy, identifying biomarkers that can indicate the risk of developing perinatal mental disorders, and designing strategies to prevent mother and infant suffering during the delicate and critical peripartum period,” Dr. Carmona added.
The study was supported by the Center for Integrative Neuroscience in Tübingen, Germany, and the International Research Training Group “Women’s Mental Health Across the Reproductive Years” (IRTG 2804). Ms. Weinmar and Dr. Carmona reported no relevant disclosures.
A version of this article appeared on Medscape.com.
MILAN, ITALY — Pregnant women with heightened amygdala activity have a reduced capacity to regulate emotions and report more symptoms of depression than those with lower activity in this brain region, a new imaging study suggested.
If validated, these findings could pave the way for identifying women at higher risk for postpartum depression, said lead researcher Franziska Weinmar, MSc, from the University of Tübingen in Germany.
The study was presented at the 37th European College of Neuropsychopharmacology Congress.
Differences in Brain Activity
During pregnancy and the peripartum period, rising hormone levels create a “psychoneuroendocrinological window of vulnerability” for mental health in which 80% of women can develop transitory “baby blues,” and about one in seven develop more serious postpartum depression, Ms. Weinmar told this news organization.
The study included 47 women — 15 pregnant women and 32 nonpregnant controls. The nonpregnant women had normal menstrual cycles; 16 were in the early follicular phase with low estradiol levels (231.7 pmol/L), and 16 had high estradiol levels (516.6 pmol/L) after administration of estradiol.
To examine brain activity, participants were asked to view negative emotional images while undergoing functional MRI. They were then asked to use cognitive reappraisal to regulate their emotional response to the images.
The findings showed that both pregnant and nonpregnant women were equally successful at emotional regulation, but this process involved different brain activity in pregnant vs their nonpregnant counterpart.
All women had increased left middle frontal gyrus activity when regulating their emotions, but there was a difference in the amygdala between the pregnancy group and controls, Ms. Weinmar noted.
This suggests that pregnant women may have to exert more neural effort in emotional regulation, she said. “And pregnant women with higher amygdala activity were less able to regulate their emotions successfully compared to those with less amygdala activity.”
Linear regression analyses were performed to assess the relation of brain activity during down-regulation, regulation success, and self-reported depression scores, and this showed that higher amygdala activity was also associated with higher depression scores.
“We need to be cautious in interpreting this,” said Ms. Weinmar. “This is a small sample, and we are the first to undertake this work.”
Nonetheless, she said that if the findings are confirmed by larger studies, pregnant women could be assessed “in the waiting room” using existing questionnaires that evaluate emotional regulation.
If a woman has difficulties with emotion regulation, “there are adaptive strategies, like cognitive reappraisal that a counseling psychotherapist can help with,” said Ms. Weinmar.
“I could also imagine group sessions, for example, or online courses,” she said, adding that obstetricians could also be trained to identify these women.
Commenting on the findings in a press release, Susana Carmona, PhD, from Gregorio Marañón Hospital in Madrid, Spain, said research like this is crucial for gaining insight into one of the most intense physiological processes a human can undergo: pregnancy. It’s remarkable how much remains unknown.
“Recently, the FDA [Food and Drug Administration] approved the first treatment for postpartum depression. However, we still have a long way to go in characterizing what happens in the brain during pregnancy, identifying biomarkers that can indicate the risk of developing perinatal mental disorders, and designing strategies to prevent mother and infant suffering during the delicate and critical peripartum period,” Dr. Carmona added.
The study was supported by the Center for Integrative Neuroscience in Tübingen, Germany, and the International Research Training Group “Women’s Mental Health Across the Reproductive Years” (IRTG 2804). Ms. Weinmar and Dr. Carmona reported no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM ECNP 2024
Treatment-Resistant Depression Linked to Increased Mortality
TOPLINE:
Treatment-resistant major depression (TRD) is associated with a 17% higher risk for all-cause mortality than non-TRD major depressive disorder (MDD), a new study shows. The increased mortality risk was driven largely by suicide and accidental overdose, which were nearly twice as high among people whose depression didn’t improve after two treatments.
METHODOLOGY:
- Data on 176,942 individuals diagnosed with MDD and treated with an antidepressant (median age at diagnosis, 40 years; 63% women) were obtained from Finnish nationwide registers.
- About 11% of the participants had TRD, defined as having more than two adequate treatment trials of at least 28 days, each within 2 years from the index antidepressant prescription.
- The outcomes were all-cause and cause-specific mortality, with demographic characteristics, psychiatric comorbidities, and treatment history included as covariates.
- The median follow-up period was 8.9 years.
TAKEAWAY:
- Median time to TRD was 8 months, and 959 and 7662 deaths were observed in the TRD and non-TRD groups, respectively.
- All-cause mortality was 17% higher among patients with TRD than among those with non-TRD (adjusted hazard ratio [aHR], 1.17; 95% CI, 1.09-1.25) because of higher mortality to external causes.
- Mortalities because of suicides (aHR, 1.90; 95% CI, 1.64-2.20) and accidental poisonings (aHR, 1.81; 95% CI, 1.48-2.22) were almost double in the TRD group, compared with the non-TRD group.
- No significant difference in mortality due to natural causes was observed between the TRD and non-TRD groups.
IN PRACTICE:
“The markedly increased mortality due to suicides and accidental overdoses suggests that persons with TRD may experience higher-intensity symptoms and more severe suicidal ideation than persons with non-TRD major depression,” the study authors wrote.
SOURCE:
The study was led by Tapio T. Gustafsson, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland. It was published online on September 11, 2024, in The Journal of Affective Disorders.
LIMITATIONS:
The definition of TRD lacked consensus. The study used routine data to define TRD, which may not have captured all relevant clinical nuances. Additionally, the reasons for medication changes were unavailable.
DISCLOSURES:
This study was funded by Johnson & Johnson Innovative Medicine and Niuvanniemi Hospital, with support from the Finnish Ministry of Social Affairs and Health. Several authors disclosed financial relationships with various pharmaceutical companies, and two are employees of Johnson & Johnson Innovative Medicine.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Treatment-resistant major depression (TRD) is associated with a 17% higher risk for all-cause mortality than non-TRD major depressive disorder (MDD), a new study shows. The increased mortality risk was driven largely by suicide and accidental overdose, which were nearly twice as high among people whose depression didn’t improve after two treatments.
METHODOLOGY:
- Data on 176,942 individuals diagnosed with MDD and treated with an antidepressant (median age at diagnosis, 40 years; 63% women) were obtained from Finnish nationwide registers.
- About 11% of the participants had TRD, defined as having more than two adequate treatment trials of at least 28 days, each within 2 years from the index antidepressant prescription.
- The outcomes were all-cause and cause-specific mortality, with demographic characteristics, psychiatric comorbidities, and treatment history included as covariates.
- The median follow-up period was 8.9 years.
TAKEAWAY:
- Median time to TRD was 8 months, and 959 and 7662 deaths were observed in the TRD and non-TRD groups, respectively.
- All-cause mortality was 17% higher among patients with TRD than among those with non-TRD (adjusted hazard ratio [aHR], 1.17; 95% CI, 1.09-1.25) because of higher mortality to external causes.
- Mortalities because of suicides (aHR, 1.90; 95% CI, 1.64-2.20) and accidental poisonings (aHR, 1.81; 95% CI, 1.48-2.22) were almost double in the TRD group, compared with the non-TRD group.
- No significant difference in mortality due to natural causes was observed between the TRD and non-TRD groups.
IN PRACTICE:
“The markedly increased mortality due to suicides and accidental overdoses suggests that persons with TRD may experience higher-intensity symptoms and more severe suicidal ideation than persons with non-TRD major depression,” the study authors wrote.
SOURCE:
The study was led by Tapio T. Gustafsson, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland. It was published online on September 11, 2024, in The Journal of Affective Disorders.
LIMITATIONS:
The definition of TRD lacked consensus. The study used routine data to define TRD, which may not have captured all relevant clinical nuances. Additionally, the reasons for medication changes were unavailable.
DISCLOSURES:
This study was funded by Johnson & Johnson Innovative Medicine and Niuvanniemi Hospital, with support from the Finnish Ministry of Social Affairs and Health. Several authors disclosed financial relationships with various pharmaceutical companies, and two are employees of Johnson & Johnson Innovative Medicine.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Treatment-resistant major depression (TRD) is associated with a 17% higher risk for all-cause mortality than non-TRD major depressive disorder (MDD), a new study shows. The increased mortality risk was driven largely by suicide and accidental overdose, which were nearly twice as high among people whose depression didn’t improve after two treatments.
METHODOLOGY:
- Data on 176,942 individuals diagnosed with MDD and treated with an antidepressant (median age at diagnosis, 40 years; 63% women) were obtained from Finnish nationwide registers.
- About 11% of the participants had TRD, defined as having more than two adequate treatment trials of at least 28 days, each within 2 years from the index antidepressant prescription.
- The outcomes were all-cause and cause-specific mortality, with demographic characteristics, psychiatric comorbidities, and treatment history included as covariates.
- The median follow-up period was 8.9 years.
TAKEAWAY:
- Median time to TRD was 8 months, and 959 and 7662 deaths were observed in the TRD and non-TRD groups, respectively.
- All-cause mortality was 17% higher among patients with TRD than among those with non-TRD (adjusted hazard ratio [aHR], 1.17; 95% CI, 1.09-1.25) because of higher mortality to external causes.
- Mortalities because of suicides (aHR, 1.90; 95% CI, 1.64-2.20) and accidental poisonings (aHR, 1.81; 95% CI, 1.48-2.22) were almost double in the TRD group, compared with the non-TRD group.
- No significant difference in mortality due to natural causes was observed between the TRD and non-TRD groups.
IN PRACTICE:
“The markedly increased mortality due to suicides and accidental overdoses suggests that persons with TRD may experience higher-intensity symptoms and more severe suicidal ideation than persons with non-TRD major depression,” the study authors wrote.
SOURCE:
The study was led by Tapio T. Gustafsson, University of Eastern Finland, Niuvanniemi Hospital, Kuopio, Finland. It was published online on September 11, 2024, in The Journal of Affective Disorders.
LIMITATIONS:
The definition of TRD lacked consensus. The study used routine data to define TRD, which may not have captured all relevant clinical nuances. Additionally, the reasons for medication changes were unavailable.
DISCLOSURES:
This study was funded by Johnson & Johnson Innovative Medicine and Niuvanniemi Hospital, with support from the Finnish Ministry of Social Affairs and Health. Several authors disclosed financial relationships with various pharmaceutical companies, and two are employees of Johnson & Johnson Innovative Medicine.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Optimizing Likelihood of Treatment for Postpartum Depression: Assessment of Barriers to Care
I have written in my first two columns of 2024 about how the obstacles for women to access perinatal mental healthcare are not well understood. This is despite an almost uniform adoption of screening practices for postpartum depression (PPD) over the last 10-15 years in the United States, the approval and off-label use of effective pharmacologic and nonpharmacologic treatments for PPD, and the growing numbers of perinatal access programs across the country in various states and hospitals.
I want to revisit this topic because I believe it is extremely important that we get to a better understanding of the obstacles postpartum patients experience so we can flatten the curve with respect to the perinatal treatment cascade. It turns out that screening is easy but accessing care for those with a positive screen with significant depressive symptoms is an entirely distinct outcome.
Recently, a group of investigators examined the barriers to identifying and treating women for PPD. In a meta-analysis that included 32 reviews, the researchers analyzed the barriers women face when they seek help, access care, and engage in treatment for mental health issues while pregnant or in the postpartum period. The researchers found women have a wide variety of barriers to seeking and accessing care related to societal, political, organizational, interpersonal, healthcare professional, and individual factors at every level of the care pathway. In total, the researchers categorized barriers into six overarching themes and 62 sub-themes, and I want to highlight a few of the biggest contributors below.
In the meta-analysis, a major contributor to deciding to consult with a healthcare professional was a lack of understanding of what constituted a perinatal mental illness. This lack of understanding led women to ignore or minimize their symptoms. Others said that the cost of travel or arranging childcare were factors that prevented them from making an appointment with a provider. Some women reported that their healthcare professionals’ normalization of their symptoms was a barrier in the early stages of the care pathway, and others were unclear about the role a healthcare professional played in involving social services and removing their child from their care, or feared being judged as a bad mom.
One of the major societal factors identified in the study is the stigma associated with PPD. It is unfortunate that for so many postpartum patients, an extraordinary stigma associated with PPD still persists despite efforts from a large number of stakeholders, including the scientific community, advocacy groups, and celebrities who have publicly come out and described their experiences with PPD. For so many postpartum patients, there is an inability to let go of the stigma, shame, humiliation, and isolation associated with the suffering that goes along with PPD.
Another factor identified in the study as being an obstacle to care was a lack of a network to help postpartum patients navigate the shifting roles associated with new parenthood, which is magnified if a patient has developed major depressive disorder. This is why a strong social support network is critical to help women navigate the novelty of being a new mom. We were aware of this as a field nearly 30 years ago when Michael W. O’Hara, PhD, published a paper in the Archives of General Psychiatry noting that social support was an important predictor for risk of PPD.
When we talk with patients in clinic, and even when we interviewed subjects for our upcoming documentary More Than Blue, which will be completed in the fall of 2024, women in the postpartum period have cited the navigation of our current healthcare system as one of the greatest obstacles to getting care. Suffering from PPD and being handed a book of potential providers, absent someone helping to navigate that referral system, is really asking a new mom to climb a very tall mountain. Additionally, moms living in rural areas likely don’t have the sort of access to perinatal mental health services that women in more urban areas do.
It becomes increasingly clear that it is not the lack of availability of effective treatments that is the problem. As I’ve mentioned in previous columns, the last 15 years has given us a much greater understanding of the effectiveness of antidepressants as well as nonpharmacologic psychotherapies for women who may not want to be on a medicine. We now have very effective psychotherapies and there’s excitement about other new treatments that may have a role in the treatment of postpartum depression, including the use of neurosteroids, ketamine or esketamine, and psychedelics or neuromodulation such as transcranial magnetic stimulation. There is also no dearth of both well-studied treatments and even new and effective treatments that, as we move toward precision reproductive psychiatry, may be useful in tailoring treatment for patients.
If we’re looking to understand the anatomy of the perinatal treatment cascade, finally systematically evaluating these barriers may lead us down a path to understand how to build the bridge to postpartum wellness for women who are suffering. While what’s on the horizon is very exciting, we still have yet to address these barriers that prevent women from accessing this expanding array of treatment options. That is, in fact, the challenge to patients, their families, advocacy groups, political organizations, and society in general. The bridging of that gap is a burden that we all share as we try to mitigate the suffering associated with such an exquisitely treatable illness while access to treatment still feels beyond reach of so many postpartum persons around us.
As we continue our research on new treatments, we should keep in mind that they will be of no value unless we understand how to facilitate access to these treatments for the greatest number of patients. This endeavor really highlights the importance of health services research and implementation science, and that we need to be partnering early and often with colleagues if we are to truly achieve this goal.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected]
I have written in my first two columns of 2024 about how the obstacles for women to access perinatal mental healthcare are not well understood. This is despite an almost uniform adoption of screening practices for postpartum depression (PPD) over the last 10-15 years in the United States, the approval and off-label use of effective pharmacologic and nonpharmacologic treatments for PPD, and the growing numbers of perinatal access programs across the country in various states and hospitals.
I want to revisit this topic because I believe it is extremely important that we get to a better understanding of the obstacles postpartum patients experience so we can flatten the curve with respect to the perinatal treatment cascade. It turns out that screening is easy but accessing care for those with a positive screen with significant depressive symptoms is an entirely distinct outcome.
Recently, a group of investigators examined the barriers to identifying and treating women for PPD. In a meta-analysis that included 32 reviews, the researchers analyzed the barriers women face when they seek help, access care, and engage in treatment for mental health issues while pregnant or in the postpartum period. The researchers found women have a wide variety of barriers to seeking and accessing care related to societal, political, organizational, interpersonal, healthcare professional, and individual factors at every level of the care pathway. In total, the researchers categorized barriers into six overarching themes and 62 sub-themes, and I want to highlight a few of the biggest contributors below.
In the meta-analysis, a major contributor to deciding to consult with a healthcare professional was a lack of understanding of what constituted a perinatal mental illness. This lack of understanding led women to ignore or minimize their symptoms. Others said that the cost of travel or arranging childcare were factors that prevented them from making an appointment with a provider. Some women reported that their healthcare professionals’ normalization of their symptoms was a barrier in the early stages of the care pathway, and others were unclear about the role a healthcare professional played in involving social services and removing their child from their care, or feared being judged as a bad mom.
One of the major societal factors identified in the study is the stigma associated with PPD. It is unfortunate that for so many postpartum patients, an extraordinary stigma associated with PPD still persists despite efforts from a large number of stakeholders, including the scientific community, advocacy groups, and celebrities who have publicly come out and described their experiences with PPD. For so many postpartum patients, there is an inability to let go of the stigma, shame, humiliation, and isolation associated with the suffering that goes along with PPD.
Another factor identified in the study as being an obstacle to care was a lack of a network to help postpartum patients navigate the shifting roles associated with new parenthood, which is magnified if a patient has developed major depressive disorder. This is why a strong social support network is critical to help women navigate the novelty of being a new mom. We were aware of this as a field nearly 30 years ago when Michael W. O’Hara, PhD, published a paper in the Archives of General Psychiatry noting that social support was an important predictor for risk of PPD.
When we talk with patients in clinic, and even when we interviewed subjects for our upcoming documentary More Than Blue, which will be completed in the fall of 2024, women in the postpartum period have cited the navigation of our current healthcare system as one of the greatest obstacles to getting care. Suffering from PPD and being handed a book of potential providers, absent someone helping to navigate that referral system, is really asking a new mom to climb a very tall mountain. Additionally, moms living in rural areas likely don’t have the sort of access to perinatal mental health services that women in more urban areas do.
It becomes increasingly clear that it is not the lack of availability of effective treatments that is the problem. As I’ve mentioned in previous columns, the last 15 years has given us a much greater understanding of the effectiveness of antidepressants as well as nonpharmacologic psychotherapies for women who may not want to be on a medicine. We now have very effective psychotherapies and there’s excitement about other new treatments that may have a role in the treatment of postpartum depression, including the use of neurosteroids, ketamine or esketamine, and psychedelics or neuromodulation such as transcranial magnetic stimulation. There is also no dearth of both well-studied treatments and even new and effective treatments that, as we move toward precision reproductive psychiatry, may be useful in tailoring treatment for patients.
If we’re looking to understand the anatomy of the perinatal treatment cascade, finally systematically evaluating these barriers may lead us down a path to understand how to build the bridge to postpartum wellness for women who are suffering. While what’s on the horizon is very exciting, we still have yet to address these barriers that prevent women from accessing this expanding array of treatment options. That is, in fact, the challenge to patients, their families, advocacy groups, political organizations, and society in general. The bridging of that gap is a burden that we all share as we try to mitigate the suffering associated with such an exquisitely treatable illness while access to treatment still feels beyond reach of so many postpartum persons around us.
As we continue our research on new treatments, we should keep in mind that they will be of no value unless we understand how to facilitate access to these treatments for the greatest number of patients. This endeavor really highlights the importance of health services research and implementation science, and that we need to be partnering early and often with colleagues if we are to truly achieve this goal.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected]
I have written in my first two columns of 2024 about how the obstacles for women to access perinatal mental healthcare are not well understood. This is despite an almost uniform adoption of screening practices for postpartum depression (PPD) over the last 10-15 years in the United States, the approval and off-label use of effective pharmacologic and nonpharmacologic treatments for PPD, and the growing numbers of perinatal access programs across the country in various states and hospitals.
I want to revisit this topic because I believe it is extremely important that we get to a better understanding of the obstacles postpartum patients experience so we can flatten the curve with respect to the perinatal treatment cascade. It turns out that screening is easy but accessing care for those with a positive screen with significant depressive symptoms is an entirely distinct outcome.
Recently, a group of investigators examined the barriers to identifying and treating women for PPD. In a meta-analysis that included 32 reviews, the researchers analyzed the barriers women face when they seek help, access care, and engage in treatment for mental health issues while pregnant or in the postpartum period. The researchers found women have a wide variety of barriers to seeking and accessing care related to societal, political, organizational, interpersonal, healthcare professional, and individual factors at every level of the care pathway. In total, the researchers categorized barriers into six overarching themes and 62 sub-themes, and I want to highlight a few of the biggest contributors below.
In the meta-analysis, a major contributor to deciding to consult with a healthcare professional was a lack of understanding of what constituted a perinatal mental illness. This lack of understanding led women to ignore or minimize their symptoms. Others said that the cost of travel or arranging childcare were factors that prevented them from making an appointment with a provider. Some women reported that their healthcare professionals’ normalization of their symptoms was a barrier in the early stages of the care pathway, and others were unclear about the role a healthcare professional played in involving social services and removing their child from their care, or feared being judged as a bad mom.
One of the major societal factors identified in the study is the stigma associated with PPD. It is unfortunate that for so many postpartum patients, an extraordinary stigma associated with PPD still persists despite efforts from a large number of stakeholders, including the scientific community, advocacy groups, and celebrities who have publicly come out and described their experiences with PPD. For so many postpartum patients, there is an inability to let go of the stigma, shame, humiliation, and isolation associated with the suffering that goes along with PPD.
Another factor identified in the study as being an obstacle to care was a lack of a network to help postpartum patients navigate the shifting roles associated with new parenthood, which is magnified if a patient has developed major depressive disorder. This is why a strong social support network is critical to help women navigate the novelty of being a new mom. We were aware of this as a field nearly 30 years ago when Michael W. O’Hara, PhD, published a paper in the Archives of General Psychiatry noting that social support was an important predictor for risk of PPD.
When we talk with patients in clinic, and even when we interviewed subjects for our upcoming documentary More Than Blue, which will be completed in the fall of 2024, women in the postpartum period have cited the navigation of our current healthcare system as one of the greatest obstacles to getting care. Suffering from PPD and being handed a book of potential providers, absent someone helping to navigate that referral system, is really asking a new mom to climb a very tall mountain. Additionally, moms living in rural areas likely don’t have the sort of access to perinatal mental health services that women in more urban areas do.
It becomes increasingly clear that it is not the lack of availability of effective treatments that is the problem. As I’ve mentioned in previous columns, the last 15 years has given us a much greater understanding of the effectiveness of antidepressants as well as nonpharmacologic psychotherapies for women who may not want to be on a medicine. We now have very effective psychotherapies and there’s excitement about other new treatments that may have a role in the treatment of postpartum depression, including the use of neurosteroids, ketamine or esketamine, and psychedelics or neuromodulation such as transcranial magnetic stimulation. There is also no dearth of both well-studied treatments and even new and effective treatments that, as we move toward precision reproductive psychiatry, may be useful in tailoring treatment for patients.
If we’re looking to understand the anatomy of the perinatal treatment cascade, finally systematically evaluating these barriers may lead us down a path to understand how to build the bridge to postpartum wellness for women who are suffering. While what’s on the horizon is very exciting, we still have yet to address these barriers that prevent women from accessing this expanding array of treatment options. That is, in fact, the challenge to patients, their families, advocacy groups, political organizations, and society in general. The bridging of that gap is a burden that we all share as we try to mitigate the suffering associated with such an exquisitely treatable illness while access to treatment still feels beyond reach of so many postpartum persons around us.
As we continue our research on new treatments, we should keep in mind that they will be of no value unless we understand how to facilitate access to these treatments for the greatest number of patients. This endeavor really highlights the importance of health services research and implementation science, and that we need to be partnering early and often with colleagues if we are to truly achieve this goal.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital (MGH) in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Full disclosure information for Dr. Cohen is available at womensmentalhealth.org. Email Dr. Cohen at [email protected]
Signal of Suicide Ideation With GLP-1 RA Semaglutide, but Experts Urge Caution
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.
A new analysis has detected a signal of suicidal ideation associated with the glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide, especially among individuals concurrently using antidepressants or benzodiazepines.
However, the investigators and outside experts urge caution in drawing any firm conclusions based on the study’s observations.
,” study investigator Georgios Schoretsanitis, MD, PhD, Department of Psychiatry, The Zucker Hillside Hospital, Northwell Health, Glen Oaks, New York, told this news organization.
Nonetheless, “physicians prescribing semaglutide should inform their patients about the medications’ risks and assess the psychiatric history and evaluate the mental state of patients before starting treatment with semaglutide,” Dr. Schoretsanitis said.
“For patients with history of mental disorders or suicidal ideation/behaviors/attempts, physicians should be cautious and regularly monitor their mental state while taking semaglutide. If needed, the treating physician should involve different specialists, including a psychiatrist and/or clinical psychologists,” he added.
The study was published online on August 20 in JAMA Network Open.
Emerging Concerns
GLP-1 RAs are increasingly prescribed not only for type 2 diabetes but also for weight loss. However, concerns have emerged about a potential association with suicidality, which has prompted a closer look by regulators in the United States and Europe.
Dr. Schoretsanitis and colleagues evaluated potential signals of suicidality related to semaglutide and liraglutide using data from global World Health Organization database of suspected adverse drug reactions (ADRs).
They conducted sensitivity analyses including patients with co-reported use of antidepressants and benzodiazepines and using dapagliflozin, metformin, and orlistat as comparators.
Between November 2000 and August 2023, there were 107 cases of suicidal and/or self-injurious ADRs reported with semaglutide (median age, 48 years; 55% women) and 162 reported with liraglutide (median age 47 years; 61% women).
The researchers noted that a “significant disproportionality” signal emerged for semaglutide-associated suicidal ideation (reporting odds ratio [ROR], 1.45), when compared with comparator drugs.
This signal remained significant in sensitivity analyses that included patients on concurrent antidepressants (ROR, 4.45) and benzodiazepines (ROR, 4.07), “suggesting that people with anxiety and depressive disorders may be at higher probability of reporting suicidal ideation when medicated with semaglutide,” the authors wrote.
No significant disproportionality signal was detected for liraglutide regarding suicidal ideation (ROR, 1.04).
However, the authors noted that pooled data from previous phase 2 and 3 trials on liraglutide vs placebo for weight management identified a potential risk for suicidal ideation, with nine of 3384 participants in the liraglutide group vs two of 1941 in the placebo group reporting suicidal ideation or behavior during the trial (0.27% vs 0.10%).
More Research Needed
GLP-1 RAs “should be used cautiously until further data are available on this topic,” Dr. Schoretsanitis said.
“Further real-world studies should investigate the risk of suicidal ideation or behavior in people treated with these drugs in every-day clinical practice. We categorically discourage off-label use of GLP1-RA and without any medical supervision,” he added.
The coauthors of an invited commentary published with the study note that between 2020 and 2023, GLP-1 RA use rose 594% in younger people, particularly in women.
This “timely and well-conducted study” by Dr. Schoretsanitis and colleagues adds “an important piece to the very relevant safety issue” related to GLP-1 RAs, wrote Francesco Salvo, MD, PhD, with Université de Bordeaux, and Jean-Luc Faillie, MD, PhD, with Université de Montpellier, both in France.
Pending further studies, the position of the US Food and Drug Administration (FDA) recommending caution “continues to be reasonable. Whatever the cause, depression or suicidality are rare but extremely severe events and need to be prevented and managed as much as possible.
“Waiting for more precise data, GPL-1 receptor agonists, and appetite suppressants in general, should be prescribed with great caution in patients with a history of depression or suicidal attempts, while in patients with new onset of depression without other apparent precipitants, immediate discontinuation of GLP-1 receptor agonists should be considered,” wrote Dr. Salvo and Dr. Faillie.
Outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre.
The paper presents, “at best, weak evidence of an association between semaglutide and suicidality,” Ian Douglas, PhD, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, United Kingdom, said in the statement. “Signal detection studies in pharmacovigilance databases are good for generating hypotheses but are not suitable for assessing whether there is a causal association between a drug and an outcome.”
Stephen Evans, MSc, emeritus professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, cautioned that the study has “major limitations.”
“This paper is based just on spontaneous reports which are sent to regulatory authorities in the country of the person reporting a suspected adverse reaction. These are sent by health professionals and patients to authorities, but are very subject to bias, including effects of media reporting. The evidence is extremely weak for a genuine effect in this instance,” Mr. Evans said.
The study had no specific funding. Dr. Schoretsanitis reported receiving personal fees from HLS, Dexcel, Saladax, and Thermo Fisher outside the submitted work. Dr. Salvo and Dr. Faillie have no conflicts of interest. Dr. Douglas has received research grants from GSK and AstraZeneca. Mr. Evans has no conflicts of interest.
A version of this article appeared on Medscape.com.