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.
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.
Key Words
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Article Info
Publication History
Accepted:
September 22,
2000
Footnotes
The study was sponsored by grants from Solvay Pharmaceuticals, Inc., Marietta, GA. The authors thank site investigators Drs. Dennis Cantwell (deceased), William Nathan, Steven Rasmussen, Neal Ryan, and Harold Udelman and coinvestigators and other study personnel at the 17 study sites as well as the clinical research staff at Solvay Pharmaceuticals, Inc., for their contributions to this study.
Identification
Copyright
© 2001 The American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.
