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

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

      • Chiba prefecture, Japan
        • S114.3.118 Kohnodai Hospital, National Center of N
      • Fukuoka prefecture, Japan
        • S114.3.118 Kyushu University Hospital
      • Hiroshima prefecture, Japan
        • S114.3.118 Hiroshima-city Funairi Hospital
      • Hokkaido prefecture, Japan
        • S114.3.118 Goryokai Hospital
      • Hyogo prefecture, Japan
        • S114.3.118 Hyogo Children's Hospital
      • Hyogo prefecture, Japan
        • S114.3.118 Kobe University Hospital
      • Kagawa prefecture, Japan
        • S114.3.118 National Hospital Organization Kagawa C
      • Kumamoto prefecture, Japan
        • S114.3.118 National Hospital Organization Kikuti N
      • Mie prefecuture, Japan
        • S114.3.118 National Hospital Organization Sakakiba
      • Nara prefecture, Japan
        • S114.3.118 Nara Medical University Hospital
      • Tokushima prefecture, Japan
        • S114.3.118 Tokushima University Hospital

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.

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

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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