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The first double-blind, placebo-controlled trial demonstrating the efficacy of an SSRI in treating children and adolescents with major depression was not published until 1997, with the finding that fluoxetine was superior to placebo1. In that study, the response rate on active drug was 56%, versus 33% on placebo. Subsequently, a larger, 9-week trial demonstrated similar findings, with 41% of subjects on fluoxetine achieving remission versus 20% on placebo2. Then, in January 2003, an FDA indication was obtained for fluoxetine in children and adolescents for the treatment of major depression.
The recently completed National Institute of Mental Health-funded multicenter study of the effects of fluoxetine alone or in conjunction with cognitive-b…