Fluvoxamine for children and adolescents with obsessive-compulsive disorder: a randomized, controlled, multicenter trial.
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.
Riddle
M A
MA
Division of Child and Adolescent Psychiatry, Johns Hopkins Hospital, CMSC 346, 600 North Wolfe Street, Baltimore, MD 21287-3325, USA. mriddle@jhmi.edu
Reeve
E A
EA
Yaryura-Tobias
J A
JA
Yang
H M
HM
Claghorn
J L
JL
Gaffney
G
G
Greist
J H
JH
Holland
D
D
McConville
B J
BJ
Pigott
T
T
Walkup
J T
JT
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
D016666:Fluvoxamine; D017367:Selective Serotonin Reuptake Inhibitors