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

This study has been terminated.
(This study was prematurely terminated (26 June 2009) due to slow recruitment)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00352768
First received: July 14, 2006
Last updated: March 3, 2010
Last verified: March 2010

July 14, 2006
March 3, 2010
August 2006
April 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00352768 on ClinicalTrials.gov Archive Site
The Clinical Global Impression(CGI) improvement at Week 10 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • 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
  • Drug: Placebo
    Placebo
  • Experimental: F
    Intervention: Drug: Fluvoxamine maleate
  • Placebo Comparator: P
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
20
April 2009
April 2009   (final data collection date for primary outcome measure)

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

Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00352768
S114.3.118
Yes
Not Provided
Solvay Pharmaceuticals
Not Provided
Study Director: Toshiaki Yamaguchi Solvay Pharmaceuticals
Solvay Pharmaceuticals
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP