Fluvoxamine for children and adolescents with obsessive-compulsive disorder: A randomized, controlled, multicenter trial

Mark A. Riddle*, Elizabeth A. Reeve, Jose A. Yaryura-Tobias, Hwa Ming Yang, James L. Claghorn, Gary Gaffney, John H. Greist, Donna Holland, Brian J. Mcconville, Teresa Pigott, John T. Walkup

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

295 Scopus citations


Objective: To determine the safety and efficacy of fluvoxamine for the treatment of children and adolescents with obsessive-compulsive disorder (OCD) with a double-blind, placebo-controlled, multicenter study. Method: Subjects, aged 8 to 17 years, meeting DSM-III-R criteria for OCD were recruited from July 1991 to August 1994. After a 7- to 14-day single-blind, placebo washout/screening period, subjects were randomly assigned to fluvoxamine 50 to 200 mg/day or placebo for 10 weeks. Subjects who had not responded after 6 weeks could discontinue the double-blind phase of the study and enter a long-term, open-label trial of fluvoxamine. Analyses used an intent-to-treat sample with a last-observation-carried-forward method. Results: Mean Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores with fluvoxamine were significantly (p < .05) different from those with placebo at weeks 1, 2, 3, 4, 6, and 10. Significant (p < .05) differences between fluvoxamine and placebo were observed for all secondary outcome measures at all visits. Based on a 25% reduction of CY-BOCS scores, 42% of subjects taking fluvoxamine were responders compared with 26% taking placebo. Forty-six (19 fluvoxamine, 27 placebo) of 120 randomized subjects discontinued early. Adverse events with a placebo-adjusted rate greater than 10% were insomnia and asthenia. Conclusions: Fluvoxamine has a rapid onset of action and is well tolerated and efficacious for the short-term treatment of pediatric OCD.

Original languageEnglish (US)
Pages (from-to)222-229
Number of pages8
JournalJournal of the American Academy of Child and Adolescent Psychiatry
Issue number2
StatePublished - 2001


  • Fluvoxamine
  • Obsessive-compulsive disorder
  • Psychopharmacology

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Developmental and Educational Psychology


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