- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00352768
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents
March 3, 2010 updated by: Solvay Pharmaceuticals
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Chiba prefecture, Japan
- S114.3.118 Kohnodai Hospital, National Center of N
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Fukuoka prefecture, Japan
- S114.3.118 Kyushu University Hospital
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Hiroshima prefecture, Japan
- S114.3.118 Hiroshima-city Funairi Hospital
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Hokkaido prefecture, Japan
- S114.3.118 Goryokai Hospital
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Hyogo prefecture, Japan
- S114.3.118 Hyogo Children's Hospital
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Hyogo prefecture, Japan
- S114.3.118 Kobe University Hospital
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Kagawa prefecture, Japan
- S114.3.118 National Hospital Organization Kagawa C
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Kumamoto prefecture, Japan
- S114.3.118 National Hospital Organization Kikuti N
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Mie prefecuture, Japan
- S114.3.118 National Hospital Organization Sakakiba
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Nara prefecture, Japan
- S114.3.118 Nara Medical University Hospital
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Tokushima prefecture, Japan
- S114.3.118 Tokushima University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: P
|
Placebo
|
Experimental: F
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The Clinical Global Impression(CGI) improvement at Week 10
Time Frame: 10 weeks
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Toshiaki Yamaguchi, Solvay Pharmaceuticals
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
July 14, 2006
First Submitted That Met QC Criteria
July 14, 2006
First Posted (Estimate)
July 17, 2006
Study Record Updates
Last Update Posted (Estimate)
March 4, 2010
Last Update Submitted That Met QC Criteria
March 3, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Personality Disorders
- Anxiety Disorders
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Anti-Anxiety Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP1A2 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Fluvoxamine
Other Study ID Numbers
- S114.3.118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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