We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00352768
First Posted: July 17, 2006
Last Update Posted: March 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Secondary Outcome Measures:
  • The Clinical Global Impression(CGI) improvement at Week 10 [ Time Frame: 10 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 14, 2006
First Posted: July 17, 2006
Last Update Posted: March 4, 2010
Last Verified: March 2010

Keywords provided by Solvay Pharmaceuticals:
Fluvoxamine Maleate
OCD
Children and Adolescents

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
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