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January 7, 2004

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

Author Affiliations

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

JAMA. 2004;291(1):40. doi:10.1001/jama.291.1.42-a

In Reply: We concur with the number needed to treat of 10 that Dr Mathews and colleagues computed; this same number appears in the original article on page 1037. The exclusion of zero in the 95% CIs calculated by Mathews et al could be viewed as a validation of our statistically significant results.

Mathews et al and and Dr Price are concerned about our ITT analysis. Furthermore, Price and Mr Spielmans are concerned about the clinical relevance of our end point. To answer these concerns, we have reanalyzed the data with respect to the CDRS-R response and have included all randomized patients as well as various levels of response criteria (Table 1). These results show that inclusion of all patients in the ITT analysis, in fact, favor sertraline and that the significance of the responder analyses was not confined to the 40% criterion. We acknowledged modifications to the ITT population in our article and we continue to feel that our analysis population is defensible and was the most conservative option. In response to concerns about clinical vs statistical significance, we feel that the 10% difference in response between treatment groups, in addition to being statistically significant, is clinically meaningful. The 65% rate in our study is a high medication response rate for children and adolescents with MDD.

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