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Letters
April 7, 2004

Sertraline and Depression in Children—Reply

Author Affiliations
 

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

JAMA. 2004;291(13):1561. doi:10.1001/jama.291.13.1561-b

In Reply: In response to Dr Garland, our combined analysis was defined a priori, well before the last participant was entered into the study and before the study was unblinded. The decision to present the combined analysis as a primary analysis and study report was made based on considerations involving use of the Children's Depression Rating Scale (CDRS) in a multicenter study. Prior to initiation of the 2 pediatric studies, the only experience with this scale in a study of selective serotonin reuptake inhibitors was in a single-center trial.1 It was unclear how the results using this scale in a smaller study could inform the power evaluation of the sample size for the 2 multicenter trials. The combined analysis reported in our article, therefore, represents a prospectively defined analysis of the overall study population. The results of the 24-week, open-label extension study, as well as an analysis of results of the acute and extension studies by age group, have been submitted for publication. The published study and submitted manuscripts represent the results of all the controlled studies of patients treated with sertraline and/or placebo in the Pfizer pediatric program.

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