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:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00352768
First received: July 14, 2006
Last updated: March 3, 2010
Last verified: March 2010
  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   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior
Maleic acid
Fluvoxamine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors

ClinicalTrials.gov processed this record on July 26, 2016