Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-Marketing Clinical Study in Children and Adolescents

Condition(s) targeted: Obsessive Compulsive Disorder

Intervention: Fluvoxamine Maleate (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

Overall contact:
Toshiaki Yamaguchi, Email: Toshiaki.Yamaguchi@solvay.com

This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder

Official title: SME3110 (Fluvoxamine Maleate) in the Treatment of Obsessive-Compulsive Disorder: A Post-Marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-Blind, Randomized, Placebo-Controlled Study

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: The time of onset of 25% decrease from baseline in the Japanese Version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item total score.

Secondary outcome: The Clinical Global Impression(CGI) improvement.

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Have a minimum total score of 16 on the JCY-BOCS, Weight is within the standard weight

± 2S. D. based on the standard weight for each age in the School Health Statistical Survey

Exclusion Criteria:

- Have the following predominant psychiatric diagnosis

- Schizophrenia

- Have previously been treated with fluvoxamine maleate

Toshiaki Yamaguchi, Email: Toshiaki.Yamaguchi@solvay.com

Site 1, Hokkaido, Japan; Recruiting

Site 2, Chiba, Japan; Recruiting

Site 3, Tokyo, Japan; Recruiting

Site 4, Kanazawa, Japan; Recruiting

Site 5, Mie, Japan; Recruiting

Site 6, Nara, Japan; Recruiting

Site 7, Kyoto, Japan; Recruiting

Site 8, Kagawa, Japan; Recruiting

Site 9, Fukuoka, Japan; Recruiting

Site 10, Kumamoto, Japan; Completed

Site 11, Osaka, Japan; Recruiting

Site 12, Osaka, Japan; Recruiting

Site 13, Tokushima, Japan; Recruiting

Site 14, Fukuoka, Japan; Recruiting

Site 15, Tokyo, Japan; Recruiting

Site 16, Nagoya, Japan; Recruiting

Site 17, Kanagawa, Japan; Recruiting

Site 18, Fukushima, Japan; Recruiting

Site 19, Fukuoka, Japan; Recruiting

Site 20, Mie, Japan; Recruiting

Site 21, Hyogo, Japan; Recruiting

Site 22, Tokyo, Japan; Withdrawn

Site 23, Nagano, Japan; Recruiting

Site 24, Nagoya, Japan; Recruiting

Site 25, Kanagawa, Japan; Recruiting

Site 26, Hiroshima, Japan; Recruiting

Site 27, Hokkaido, Japan; Recruiting

Site 28, Gunma, Japan; Recruiting

Site 29, Nagoya, Japan; Recruiting

Site 30, Osaka, Japan; Recruiting

Site 31, Tokyo, Japan; Recruiting

Site 32, Tochigi, Japan; Recruiting

Site 33, Hyogo, Japan; Recruiting

Site 34, Nagano, Japan; Recruiting

Site 35, Hyogo, Japan; Recruiting

Site 36, Oita, Japan; Recruiting

Starting date: June 2006
Ending date: June 2009
Last updated: October 24, 2008