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 trea tment of children and adolescents with obsessive-compulsive disorder (OCD) with a double-blind, placebo-controlled, multicenter study. Method: Subject s, aged 8 to 17 years, meeting DSM-III-R criteria for OCD were recruited fr om July 1991 to August 1994. After a 7- to 14-day single-blind, placebo was hout/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 lo ng-term, open-label trial of fluvoxamine. Analyses used an intent-to-treat sample with a last-observation-carried-forward method. Results: Mean Chirdr en's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) scores with fluvoxamin e were significantly (p<.05) different from those with placebo at weeks 1, 2, 3, 4, 6, and 10. Significant (p <.05) differences between fluvoxamine an d placebo were observed for all secondary outcome measures at all visits. B ased on a 25% reduction of CY-BOCS scores, 42% of subjects taking fluvoxami ne were responders compared with 26% taking placebo. Forty-six (19 fluvoxam ine, 27 placebo) of 120 randomized subjects discontinued early Adverse even ts with a placebo-adjusted rate greater than 10% were insomnia and asthenia . Conclusions: Fluvoxamine has a rapid onset of action and is well tolerate d acid efficacious for the short-term treat ment of pediatric OCD.