Back to resultsFluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents
Primary Purpose
Obsessive Compulsive Disorder
Status
Terminated
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Fluvoxamine maleate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Fluvoxamine Maleate, OCD, Children and Adolescents
Eligibility 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
Sites / Locations
- S114.3.118 Kohnodai Hospital, National Center of N
- S114.3.118 Kyushu University Hospital
- S114.3.118 Hiroshima-city Funairi Hospital
- S114.3.118 Goryokai Hospital
- S114.3.118 Hyogo Children's Hospital
- S114.3.118 Kobe University Hospital
- S114.3.118 National Hospital Organization Kagawa C
- S114.3.118 National Hospital Organization Kikuti N
- S114.3.118 National Hospital Organization Sakakiba
- S114.3.118 Nara Medical University Hospital
- S114.3.118 Tokushima University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
F
P
Arm Description
Outcomes
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
Secondary Outcome Measures
The Clinical Global Impression(CGI) improvement at Week 10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00352768
Brief Title
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
This study was prematurely terminated (26 June 2009) due to slow recruitment
Study Start Date
August 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Solvay Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Fluvoxamine Maleate, OCD, Children and Adolescents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F
Arm Type
Experimental
Arm Title
P
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fluvoxamine maleate
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The Clinical Global Impression(CGI) improvement at Week 10
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiaki Yamaguchi
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
S114.3.118 Kohnodai Hospital, National Center of N
City
Chiba prefecture
Country
Japan
Facility Name
S114.3.118 Kyushu University Hospital
City
Fukuoka prefecture
Country
Japan
Facility Name
S114.3.118 Hiroshima-city Funairi Hospital
City
Hiroshima prefecture
Country
Japan
Facility Name
S114.3.118 Goryokai Hospital
City
Hokkaido prefecture
Country
Japan
Facility Name
S114.3.118 Hyogo Children's Hospital
City
Hyogo prefecture
Country
Japan
Facility Name
S114.3.118 Kobe University Hospital
City
Hyogo prefecture
Country
Japan
Facility Name
S114.3.118 National Hospital Organization Kagawa C
City
Kagawa prefecture
Country
Japan
Facility Name
S114.3.118 National Hospital Organization Kikuti N
City
Kumamoto prefecture
Country
Japan
Facility Name
S114.3.118 National Hospital Organization Sakakiba
City
Mie prefecuture
Country
Japan
Facility Name
S114.3.118 Nara Medical University Hospital
City
Nara prefecture
Country
Japan
Facility Name
S114.3.118 Tokushima University Hospital
City
Tokushima prefecture
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents
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