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

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obsessive Compulsive Disorder

Intervention: Fluvoxamine maleate (Drug); Placebo (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Toshiaki Yamaguchi, Study Director, Affiliation: Solvay Pharmaceuticals

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: The Clinical Global Impression(CGI) improvement at Week 10

Eligibility

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

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

Locations and Contacts

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

Additional Information

Starting date: August 2006
Last updated: March 3, 2010

Page last updated: August 23, 2015

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