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January 7, 2004

Efficacy of Sertraline in the Treatment of Children and Adolescents With Major Depressive Disorder

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2004;291(1):40. doi:10.1001/jama.291.1.40-b

To the Editor: Dr Wagner and colleagues1 presented the results of 2 randomized controlled trials suggesting that sertraline is effective for treating MDD in children and adolescents. I believe the authors' statement that their findings are "clinically as well as statistically relevant" is premature.

First, it is unclear why 2 separate trials (introducing additional variability), rather than 1 larger trial, were conducted. Second, the rationale for the a priori decision to define response as a 40% decrease in depressive symptoms, rather than the more commonly used 50% decrease in symptoms, is unclear. This seems to create a bias for a favorable result for sertraline. Third, the authors used the last-observation-carried-forward method rather than a more conservative analysis considering noncompleters as nonresponders. Nonetheless, sertraline barely achieved a statistically significant improvement over placebo. It is unlikely that statistically significant results would have been observed with a more conservative analysis and a higher (and more usual) threshold for response.

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