University Times

Antidepressants are safe and effective for treating anxiety, obsessive compulsive disorder (OCD) and major depressive disorder in children and adolescents, according to a meta-analysis of 27 major studies.

The findings, published by Pitt School of Medicine researchers in this week’s Journal of the American Medical Association, call into question the controversial “black box” warnings placed on the drugs by the Food and Drug Administration, which say that antidepressant medications pose a small but significantly increased risk of suicidal thoughts and behavior for children and adolescents.

David A. Brent, professor of psychiatry in the School of Medicine, said, “The FDA should reconsider the black box warning on these medications.”

Based on the Pitt study, Brent said, “Antidepressants are safe and effective for treating disorders like anxiety, OCD and depression in children and adolescents. While there is a small, increased risk of suicidal thoughts in those who use antidepressants, it would be much, much riskier to not treat these children and adolescents.”

Pitt researchers extracted data on study characteristics, efficacy outcomes and emergent suicidal events from 27 trials of second-generation antidepressants used to treat pediatric major depressive disorder, OCD and anxiety in children and adolescents under the age of 19.

Fifteen trials focused on major depressive disorder and included a total of 3,430 participants; six trials focused on OCD, with 718 participants, and six trials focused on anxiety, with 1,162 participants.

Researchers found that one in 100 participants in the studies included in the meta-analysis had new-onset suicidal ideation, or suicidal thoughts, while on medication. Even fewer acted on these thoughts, and there were no completed suicides.

The results showed that antidepressants were most effective in treating anxiety, moderately effective for OCD and modestly effective for depression. The number needed to treat — a statistical term meaning the number of patients a clinician would need to treat to prevent an adverse outcome in one — was 10 for major depressive disorder, six for OCD and four for anxiety.

The number needed to harm — the number of patients who would need to be treated for one to be harmed — was 112 for major depressive disorder, 200 for OCD and 143 for anxiety. These numbers indicate that the increased risk, while not unimportant, is not enough to outweigh the benefits of taking the medications.

The study was funded by the National Institute of Mental Health.

Co-authors of the study include: Jeffrey A. Bridge of Ohio State University and formerly of Pitt; Satish Iyengar, Cheryl B. Salary and Boris Birmaher of the School of Medicine’s Department of Psychiatry and Western Psychiatric Institute and Clinic; Harold A. Pincus of Pitt and Columbia University; Remy P. Barbe of Pitt and the University Hospital of Geneva, and Lulu Ren, currently with AmGen.