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To the Editor: The authors of the Treatment for Adolescents With Depression Study (TADS) conclude that " . . . despite calls to restrict access to medications, medical management of MDD [major depressive disorder] with fluoxetine, including careful monitoring for adverse events, should be made widely available, not discouraged."¹ We disagree with this conclusion. Looking at the primary outcome measure (change in the Children’s Depression Rating Scale-Revised total score), fluoxetine alone resulted in minimal benefit over placebo: the placebo effects were 86% of the fluoxetine effects (change of 19.4 compared with 22.6 points). At the same time, fluoxetine caused a significantly higher rate of harm-related adverse events, such as suicidal ideation, and physiological effects (diarrhea, insomnia, and sedation) compared with placebo or cognitive-behavioral therapy (CBT) alone, as well as a higher rate of psychiatric adverse events (irritability, mania, and fatigue) compared with placebo.

Our own risk-benefit analysis of these results leads us to conclude . . . [Full Text of this Article]

David Antonuccio, PhD
oliver2@aol.com
University of Nevada School of Medicine
Reno

David Burns, MD
Stanford University School of Medicine
Palo Alto, Calif

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