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Title: Sertraline Shows Short-Term Safety, Efficacy for Major Depressive Disorder in Children and Adolescents

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JAMA 2003;290:1033-1041.
08/26/2003 04:27:34 PM
By Joene Hendry

Sertraline is effective and well-tolerated as a short-term treatment for major depressive disorder in children and adolescents, say researchers. This finding results from 2 randomised, double-blind, placebo-controlled trials conducted in the United States, Canada, India, Mexico, and Costa Rica. Karen Dineen Wagner, MD, PhD, University of Texas Medical Branch, Galveston, United States and colleagues evaluated sertraline in 376 children and adolescents, aged 6 to 17 years, diagnosed with major depressive disorder of at least moderate severity according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. A total of 189 patients were randomised to sertraline at 25 mg/day for 3 days, continuing at 50 mg/day through the second week, and titrated upward in increments of 50 mg/day every 2 weeks up to a maximum of 200 mg/day or until clinical response was achieved. The remaining 184 patients randomised to placebo received at least 1 dose of the study drug and were included in the safety evaluation. The treatment groups were evenly balanced in race, weight, and clinical and psychosocial characteristics at baseline, but there were more female patients in the sertraline group than placebo. Most patients were undergoing their first lifetime depressive episode. After 10 weeks of treatment, the investigators found a significantly greater mean reduction over baseline in the Children's Depression Rating Scale-Revised (CDRS-R) scores among patients treated with sertraline (-22.84) over placebo (-20.19). Overall, 69% of the sertraline compared with 59% of the placebo group achieved a 40% decrease from baseline in adjusted CDRS-R total score. Significant improvements were also seen in the Clinical Global Impression of Severity of Illness (CGI-S) and the Clinical Global Impression of Improvement (CGI-I) scales over baseline in patients treated with sertraline compared with placebo. Among the sertraline patients, 17 discontinued the study due to adverse events including diarrhoea, vomiting, anorexia, and agitation. Among the placebo group, 5 discontinued treatment due to adverse events. Sertraline discontinuation was not associated with withdrawal symptoms among those participating in the 10-week double-blind trial or in the patients who continued in the 24-week open label extension study. Dr. Wagner and colleagues surmise that these results indicate, "sertraline is an effective, safe, and well- tolerated short-term treatment for children and adolescents with major depressive disorder." "The significance of the results is clinically as well as statistically relevant," they add.

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