Double-Blind, Crossover Trial of Fluoxetine and Placebo in Children and Adolescents with Obsessive-Compulsive Disorder

MARK A. RIDDLE, LAWRENCE SCAHILL, ROBERT A. KING, MAUREEN T. HARDIN, GEORGE M. ANDERSON, SHARON I. ORT, J. CHRISTIAN SMITH, JAMES F. LECKMAN, DONALD J. COHEN

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1062-1069
Number of pages8
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Volume31
Issue number6
DOIs
StatePublished - 1992
Externally publishedYes

Keywords

  • fluoxetine, children
  • obsessive-compulsive disorder

ASJC Scopus subject areas

  • Developmental and Educational Psychology
  • Psychiatry and Mental health

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