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:
Solvay Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00352768
First received: July 14, 2006
Last updated: March 3, 2010
Last verified: March 2010
Tracking Information | |||||
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First Received Date ICMJE | July 14, 2006 | ||||
Last Updated Date | March 3, 2010 | ||||
Start Date ICMJE | August 2006 | ||||
Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||
Original Primary Outcome Measures ICMJE |
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 ] | ||||
Change History | Complete list of historical versions of study NCT00352768 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
The Clinical Global Impression(CGI) improvement at Week 10 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE |
The Clinical Global Impression(CGI) improvement. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents | ||||
Official Title ICMJE | 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 | ||||
Brief 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 |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Obsessive Compulsive Disorder | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Enrollment ICMJE | 20 | ||||
Completion Date | April 2009 | ||||
Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | 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 |
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Gender | Both | ||||
Ages | 8 Years to 18 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Japan | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00352768 | ||||
Other Study ID Numbers ICMJE | S114.3.118 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | |||||
Study Sponsor ICMJE | Solvay Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Solvay Pharmaceuticals | ||||
Verification Date | March 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |