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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.291.1.41-a

To the Editor: Dr Wagner and colleagues1 stated that the "significance of the results is clinically as well as statistically relevant," an assertion that reaches well beyond the trial's results. The average improvement in the main outcome measure—the CDRS-R—was 22.84 points for the sertraline group vs 20.19 points for the placebo group. The authors did not report the standard deviation, however; thus, an effect size cannot be calculated. However, simple division shows that the gains made by the placebo group were 88.4% of those in the active medication group, leaving the active medication superior by less than a 12% margin compared with an inert placebo. The slight difference between active and inactive treatment in the main outcome measure, while statistically significant, is of questionable clinical relevance. Statistically significant differences were also found on the Clinical Global Impression (CGI) Improvement and Severity of Illness scales. While these scales are popular in clinical trial research, there is scant evidence about their validity.2,3 On the remaining 3 outcome measures, no statistically significant differences were observed.