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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:
ClinicalTrials.gov Identifier:
NCT00352768
First Posted: July 17, 2006
Last Update Posted: March 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
July 14, 2006
July 17, 2006
March 4, 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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: All
8 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00352768
S114.3.118
Yes
Not Provided
Not Provided
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