PHILADELPHIA—Taking the weight-loss drug semaglutide did not increase the risk of depressive symptoms, suicidal thoughts or suicidal behavior in people without known serious mental health disorders, according to a new study led by researchers from the Perelman School of Medicine at the University of Pennsylvania published this week in JAMA Internal Medicine. Both the Food and Drug Administration (FDA) and the European Medicines Agency actively monitor the psychiatric safety of semaglutide and similar drugs following post-marketing surveillance reports of depression, suicidal ideation (thoughts), and suicidal behavior in patients taking the drugs. type 2 diabetes or obesity.
Semaglutide has emerged as a significant advance in the field of weight management. The drug was originally developed as a treatment for type 2 diabetes and attracted much attention after clinical trials showed it reduced baseline body weight by approximately 10%-15%. Weekly injectable drugs such as semaglutide have become a popular choice for healthcare providers to prescribe to patients. As many as 5 million Americans were prescribed semaglutide by 2023, with nearly four in ten taking it for weight management.
The new study, led by Thomas Wadden, PhD, professor of psychology in psychiatry and former director of Penn’s Center for Weight and Eating Disorders, analyzed data from over 3,500 participants in four large clinical trials. Researchers looked at data from the Semaglutide Treatment Effect in People with Obesity (STEP) studies – STEP 1, 2, 3 and 5. These studies were crucial to obtaining FDA approval for semaglutide 2.4 mg in obesity.
“The STEP trials provide strong evidence that semaglutide 2.4 mg reduces body weight and improves multiple health problems associated with obesity. Our new analyzes provide reassurance that the drug, when taken by individuals without significant mental health concerns, does not increase risk. about depression, suicidal thoughts, or suicidal behavior,” Wadden said, however, that more research is needed on the psychiatric safety of semaglutide 2.4 mg when used by people with current major depression, other serious mental illnesses (such as schizophrenia. ), or a history of suicide attempts. Individuals with such diseases were not included in the STEP studies.
The study examined changes in depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) and assessed suicidal ideation and behavior using the Columbia Suicide Severity Rating Scale. In the 68-week STEP 1-3 studies, participants who received semaglutide, compared to those who received placebo, did not show an increased risk of developing moderate symptoms of depression or suicidal ideation or behavior. Similar results were observed in the 104-week STEP 5 study.
Looking at all four STEP studies, researchers found that 1% or fewer of participants reported suicidal thoughts or behavior during treatment, with no difference between semaglutide 2.4 mg and placebo. In addition, only 2.8% of participants who received semaglutide, versus 4.1% of those who received placebo, reported depression at some point during treatment that required evaluation by a mental health professional. This rate is consistent with the risk of major depression in the general population. “It is certainly possible that overweight or obese individuals taking semaglutide may experience depressive symptoms or suicidal thoughts or behaviors, but the data suggest that individuals not taking semaglutide—in the placebo group in this study—are just as likely to experience these conditions, ” said Gregory Brown, PhD, co-author of the study and director of the Penn Center for the Prevention of Suicide at the Perelman School of Medicine. Wadden and Brown noted that the results of their study on semaglutide are consistent with the results of the FDA’s most recent analysis of post-marketing surveillance data for this class of drugs, which found no “evidence that the use of these drugs causes suicidal thoughts or actions.”
If you or a loved one is experiencing a suicidal crisis or emotional distress call the Suicide and Crisis Helpline at 988.
The study was funded by Novo Nordisk.
Editor’s note: Wadden has received funding from Novo Nordisk, as well as consulting fees from Novo Nordisk, advisory board service fees from Weight Watchers, and grant support from Eli Lilly.
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