Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents - Tabular View

Tracking Information

First Received Date ^ICMJE

July 14, 2006

Last Updated Date

September 24, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00352768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The Clinical Global Impression(CGI) improvement. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents

Official Title ^ICMJE

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

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

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Obsessive Compulsive Disorder

Intervention ^ICMJE

Drug: Fluvoxamine Maleate
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

8 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00352768

Responsible Party

Toshiaki Yamaguchi, Solvay Pharmaceuticals

Study ID Numbers ^ICMJE

S114.3.118

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP