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Fluvoxamine Maleate in the Treatment of Depression/Depressive State : 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: Major Depressive Disorder

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

Phase: Phase 4

Status: Completed

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 8 weeks in the treatment of children and adolescents with depression or depressive state

Clinical Details

Official title: SME3110 (Fluvoxamine Maleate) in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placeb-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 50% decrease from baseline in the Japanese Version of the Structured Interview Guide for the Hamilton Depression Rating Scale (JSIGH-D) 17-item total score

Secondary outcome: The Clinical Global Impression(CGI) improvement at Week 8

Eligibility

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

Criteria:

Inclusion Criteria Have a minimum total score of 18 on the JSIGH-D, 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

S114.3.117 Kohnodai Hospital, National Center of N, Chiba prefecture, Japan

S114.3.117 Fukuoka University Hospital, Fukuoka prefecture, Japan

S114.3.117 Hatakeyama Clinic, Fukuoka prefecture, Japan

S114.3.117 Kaname Clinic, Fukuoka prefecture, Japan

S114.3.117 Kashi shinryo Clinic, Fukuoka prefecture, Japan

S114.3.117 Kashii Sanatorium, Fukuoka prefecture, Japan

S114.3.117 Kyushu University Hospital, Fukuoka prefecture, Japan

S114.3.117 Shiranui Hospital, Fukuoka prefecture, Japan

S114.3.117 Sugahara Tenjin Hospital, Fukuoka prefecture, Japan

S114.3.117 Hiroshima-city Funairi Hospital, Hiroshima prefecture, Japan

S114.3.117 Goryokai Hospital, Hokkaido prefecture, Japan

S114.3.117 Kobe University Hospital, Hyogo prefecture, Japan

S114.3.117 National Hospital Organization Kagawa C, Kagawa prefecture, Japan

S114.3.117 Yokohama City University Hospital, Kanagawa Prefecture, Japan

S114.3.117 National Hospital Organization Kikuti N, Kumamoto prefecture, Japan

S114.3.117 Kyoto University Hospital, Kyoto prefecture, Japan

S114.3.117 National Hospital Organization Sakakiba, Mie prefecuture, Japan

S114.3.117 Shinshu University Hospital, Nagano prefecture, Japan

S114.3.117 Aichi Children's Health and Medical Cen, Nagoya prefecture, Japan

S114.3.117 Nagoya Mental Clinic, Nagoya prefecture, Japan

S114.3.117 Nara Medical University Hospital, Nara prefecture, Japan

S114.3.117 Kansai Medical University Takii Hospita, Osaka prefecture, Japan

S114.3.117 Kusube Clinic, Osaka prefecture, Japan

S114.3.117 Yasuhara Children's Clinic, Osaka prefecture, Japan

S114.3.117 Tokushima University Hospital, Tokushima prefecture, Japan

Additional Information

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

Page last updated: August 23, 2015

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