Semaglutide is now widely regarded as a significant advance in the field of weight loss and obesity control. Originally developed as a treatment for type 2 diabetes, several clinical trials have shown that it reduces baseline body weight by about 10 to 15 percent. These weekly injectable medications—like semaglutide—have therefore become a popular option for overweight patients, and their physicians.
However, some research has suggested a risk of “suicidal ideation” with taking the drug, and today, health agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency are actively monitoring the psychiatric safety of semaglutide and its counterparts.
This new analysis concludes that taking the drug semaglutide, a GLP-1 agonist, does not appear to increase the risk of depressive symptoms, suicidal thoughts or suicidal behavior in people without known major mental disorders.
The study analyzes data from more than 3,500 participants from 4 major clinical trials, the Semaglutide Treatment Effect in People with obesity (STEP) trials – STEP 1, 2, 3 and 5 used in the context of the drug’s approval by the American FDA. The analysis concludes that:
- the drug, when taken by people who have no pre-existing mental health problems, does not increase the risk of depression, suicidal thoughts or behaviour;
- 1% or less of participants reported suicidal ideation or behavior during treatment, with no observable difference between semaglutide 2.4 mg and placebo;
- 2.8% of semaglutide-treated participants vs. 4.1% of controls reported levels of depression at some point during treatment.
Lead author Dr. Thomas Wadden, professor of psychiatry and former director of Penn’s Center for Weight and Eating Disorders, concludes: “These trials provide strong evidence that semaglutide reduces body weight and eliminates the risk of many health complications associated with obesity.”
“Further study is needed, however, on the psychiatric safety of semaglutide 2.4 mg when used by people who already have major depressive disorder or another serious mental illness (such as schizophrenia) or have a history of TS.”
These data are consistent with the results of the FDA’s most recent analysis of postmarketing surveillance data for this class of drugs, which did not identify “evidence that the use of these drugs induces suicidal thoughts or acts.”
The study was supported by Novo Nordisk.