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
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Purpose
This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive Compulsive Disorder |
Drug: Fluvoxamine maleate Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Solvay Pharmaceuticals:
Primary Outcome 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The Clinical Global Impression(CGI) improvement at Week 10 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | August 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: F |
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 Comparator: P |
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 8 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352768
Locations
| 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, Japan | |
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
| Study Director: | Toshiaki Yamaguchi | Solvay Pharmaceuticals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00352768 History of Changes |
| Other Study ID Numbers: | S114.3.118 |
| Study First Received: | July 14, 2006 |
| Last Updated: | March 3, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Solvay Pharmaceuticals:
|
Fluvoxamine Maleate OCD Children and Adolescents |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Maleic acid Fluvoxamine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
Serotonin Agents Physiological Effects of Drugs Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013