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NCT00352768 Clinical Trial

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

Obsessive Compulsive Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00352768
Other study ID # S114.3.118
Secondary ID
Status Terminated
Phase Phase 4
First received July 14, 2006
Last updated March 3, 2010
Start date August 2006
Est. completion date April 2009

Study information
Verified date March 2010
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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 (maximam:6 tablets), the study mmedica
• Placebo
Placebo

Locations
Country Name City State
Japan S114.3.118 Kohnodai Hospital, National Center of N Chiba prefecture
Japan S114.3.118 Kyushu University Hospital Fukuoka prefecture
Japan S114.3.118 Hiroshima-city Funairi Hospital Hiroshima prefecture
Japan S114.3.118 Goryokai Hospital Hokkaido prefecture
Japan S114.3.118 Hyogo Children's Hospital Hyogo prefecture
Japan S114.3.118 Kobe University Hospital Hyogo prefecture
Japan S114.3.118 National Hospital Organization Kagawa C Kagawa prefecture
Japan S114.3.118 National Hospital Organization Kikuti N Kumamoto prefecture
Japan S114.3.118 National Hospital Organization Sakakiba Mie prefecuture
Japan S114.3.118 Nara Medical University Hospital Nara prefecture
Japan S114.3.118 Tokushima University Hospital Tokushima prefecture

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 10 weeks No
Secondary The Clinical Global Impression(CGI) improvement at Week 10 10 weeks No
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