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AACAP: Sertraline Study Shows Safety From Suicidal Behavior in Childhood and Adolescent Major Depressive Disorder and Obsessive-Compulsive Disorder By Jerry Ingram WASHINGTON, DC -- October 25, 2004 -- Suicide-related events appear to be uncommon in younger patients taking sertraline, an antidepressant used to treat major depression and obsessive-compulsive disorder, according to pooled data from three double-blind, randomized, placebo-controlled trials. "The major take-home message is that sertraline is well-tolerated, with very few patients dropping out due to adverse events," said the lead investigator, Charlotte M.E. Kremer, MD, Pfizer Inc., New York, New York. "We endeavored to give a transparent analysis of data with this presentation." The researchers presented the findings here on October 21st at the 51st Annual Meeting of the American Academy of Child and Adolescent Psychiatry. Based on growing concern over the safety and related suicidal behavior among young patients taking antidepressants such as sertraline, researchers decided to examine data from three large clinical trials conducted by Pfizer, reexamining the safety profiles for the use of this medication in treating children and adolescents with major depressive disorder (MDD) and obsessive-compulsive disorder (OCD). For this re-evaluation, the investigators analyzed pooled data from three clinical trials that included 560 children and adolescents between the ages of 6 and 17 years who had received sertraline as treatment for major depressive disorder or obsessive-compulsive disorder. The researchers calculated the number needed to treat (NNT) values, and number needed to harm (NNH) values. They found that discontinuation due to adverse events with sertraline occurred at a rate of 9.6% [±95% CI: 6.4-13.7], and at a rate of 2.2% [0.8-4.6] with placebo. Analysis of the group taking sertraline reflected a NNH/NNT score of 13, which the researchers concluded shows a "large margin of safety in the treatment of childhood MDD and OCD." [Presentation title: "Safety of Sertraline in Childhood Depression and Obsessive-Compulsive Disorder." Poster B18] E-mail this page to a friend or colleague! To print, use this version