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 )

First Received: July 14, 2006 Last Updated: July 10, 2009 History of Changes

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00352768

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Obsessive-Compulsive Disorder

Drug Information available for: Fluvoxamine Fluvoxamine maleate

U.S. FDA Resources

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. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	August 2006
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
F: Experimental	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 (maximum:6 tablets), the study medication will orally be administered twice daily, after breakfast and at bedtime. Duration: 10 weeks.
P: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352768

Locations

Japan
Site 2
Chiba, Japan
Site 5
Mie, Japan
Site 6
Nara, Japan
Site 8
Kagawa, Japan
Site 9
Fukuoka, Japan
Site 33
Hyogo, Japan
Site 13
Tokushima, Japan
Site 21
Hyogo, Japan
Site 26
Hiroshima, Japan
Site 27
Hokkaido, Japan
Site 10
Kumamoto, Japan

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Toshiaki Yamaguchi )
Study ID Numbers:	S114.3.118
Study First Received:	July 14, 2006
Last Updated:	July 10, 2009
ClinicalTrials.gov Identifier:	NCT00352768 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Solvay Pharmaceuticals:

Fluvoxamine Maleate, OCD, Children and Adolescents

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Fluvoxamine
Psychotropic Drugs
Central Nervous System Depressants
Serotonin Uptake Inhibitors
Serotonin

Anxiety Disorders
Mental Disorders
Maleic acid
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Obsessive-Compulsive Disorder
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Tranquilizing Agents
Fluvoxamine
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Serotonin Uptake Inhibitors
Pharmacologic Actions

Serotonin Agents
Pathologic Processes
Anxiety Disorders
Mental Disorders
Maleic acid
Therapeutic Uses
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on September 03, 2009