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Double-Blind, Crossover Trial of Fluoxetine and Placebo in Children and Adolescents with Obsessive-Compulsive Disorder.
RIDDLE, MARK A. M.D.; SCAHILL, LAWRENCE M.S.N., M.P.H.; KING, ROBERT A. M.D.; HARDIN, MAUREEN T. M.S.N.; ANDERSON, GEORGE M. PH.D.; ORT, SHARON I. R.N., M.P.H.; SMITH, J. CHRISTIAN B.A.; LECKMAN, JAMES F. M.D.; COHEN, DONALD J. M.D.
Journal of the American Academy of Child & Adolescent Psychiatry.
31(6):1062-1069, November 1992.
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Rigorously designed clinical trials have demonstrated the efficacy and safety of fluoxetine in adults with major depressive disorder and obsessive-compulsive disorder (OCD) but not in patients below 18 years old. This report describes a randomized, double-blind, placebo-controlled, fixed-dose (20 mg qd) trial of fluoxetine in 14 children and adolescents with OCD, ages 8 to 15 years old; the study was 20 weeks long with crossover at 8 weeks. Obsessive-compulsive symptom severity was measured on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) and the Clinician's Global Impression-Obsessive Compulsive Disorder scale (CGI-OCD). The CY-BOCS total score decreased 44% (N = 7, p = .003) after the initial 8 weeks of fluoxetine treatment, compared with a 27% decrease (N = 6, p = .13) after placebo. During the initial 8 weeks, the magnitude of improvement for the fluoxetine group significantly exceeded that for the placebo group as measured by the CGI-OCD (p = .01) but not by the CY-BOCS (p = .17). The most common drug side effects were generally well tolerated. The results suggest that fluoxetine is a generally safe and effective short-term treatment for children with OCD.
Copyright 1992 (C) American Academy of Child and Adolescent Psychiatry