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”

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

Study Type: Interventional

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

Study Primary Completion Date: March 2009

Intervention(s) in this Clinical Trial

• Drug: Fluvoxamine Maleate
  • Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximum:6 tablets), the study medication will orally be administered twice daily, after breakfast and at bedtime. Duration: 10 weeks.
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: F
• Placebo Comparator: P

Primary Measures

• 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.
  • Time Frame: 10 weeks
    Safety Issue?: No

Secondary Measures

• The Clinical Global Impression(CGI) improvement.
  • Time Frame: 10 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Overall Contact: Toshiaki Yamaguchi  Toshiaki.Yamaguchi@solvay.com

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00352768

Study ID Number: S114.3.118

ClinicalTrials.gov Identifier: NCT00352768

Health Authority: Japan: Ministry of Health, Labor and Welfare