title: Fluvoxamine for children and adolescents with obsessive-compulsive disorder: a randomized, controlled, multicenter trial.
abstract: 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.
  
  
  METHODS
  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.
authors.affiliation: Division of Child and Adolescent Psychiatry, Johns Hopkins Hospital, CMSC 346, 600 North Wolfe Street, Baltimore, MD 21287-3325, USA. mriddle@jhmi.edu
authors.forename: M A
authors.initials: MA
authors.lastname: Riddle
authors.forename: E A
authors.initials: EA
authors.lastname: Reeve
authors.forename: J A
authors.initials: JA
authors.lastname: Yaryura-Tobias
authors.forename: H M
authors.initials: HM
authors.lastname: Yang
authors.forename: J L
authors.initials: JL
authors.lastname: Claghorn
authors.forename: G
authors.initials: G
authors.lastname: Gaffney
authors.forename: J H
authors.initials: JH
authors.lastname: Greist
authors.forename: D
authors.initials: D
authors.lastname: Holland
authors.forename: B J
authors.initials: BJ
authors.lastname: McConville
authors.forename: T
authors.initials: T
authors.lastname: Pigott
authors.forename: J T
authors.initials: JT
authors.lastname: Walkup
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000704:Analysis of Variance; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D016666:Fluvoxamine / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009771:Obsessive-Compulsive Disorder / Q000188:drug therapy*; D017367:Selective Serotonin Reuptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D014481:United States
chemical_list: D016666:Fluvoxamine; D017367:Selective Serotonin Reuptake Inhibitors