TY - JOUR
T1 - Fluvoxamine for children and adolescents with obsessive-compulsive disorder
T2 - A randomized, controlled, multicenter trial
AU - Riddle, Mark A.
AU - Reeve, Elizabeth A.
AU - Yaryura-Tobias, Jose A.
AU - Yang, Hwa Ming
AU - Claghorn, James L.
AU - Gaffney, Gary
AU - Greist, John H.
AU - Holland, Donna
AU - Mcconville, Brian J.
AU - Pigott, Teresa
AU - Walkup, John T.
N1 - Funding Information:
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.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2001
Y1 - 2001
N2 - 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.
AB - 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.
KW - Fluvoxamine
KW - Obsessive-compulsive disorder
KW - Psychopharmacology
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U2 - 10.1097/00004583-200102000-00017
DO - 10.1097/00004583-200102000-00017
M3 - Article
C2 - 11211371
AN - SCOPUS:0035139287
SN - 0890-8567
VL - 40
SP - 222
EP - 229
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 2
ER -