Fluvoxamine Maleate in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Fluvoxamine maleate

• Registration Number: NCT00353028
• Lead Sponsor: Solvay Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-14
• Study First Submitted QC: 2006-07-14
• Study First Posted: 2006-07-17
• Study Start: 2006-10
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-03
• Last Update Posted: 2010-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P	Placebo	-
F	Fluvoxamine maleate	-

Primary Outcome Measures

Name	Time	Method
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	8 weeks

Secondary Outcome Measures

Name	Time	Method
The Clinical Global Impression(CGI) improvement at Week 8	8 weeks

Trial Locations

Locations (25)

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

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

S114.3.117 Hiroshima-city Funairi Hospital; 🇯🇵 Hiroshima prefecture, Japan

S114.3.117 Kyoto University Hospital; 🇯🇵 Kyoto prefecture, Japan

S114.3.117 Kusube Clinic; 🇯🇵 Osaka prefecture, Japan

S114.3.117 Fukuoka University Hospital; 🇯🇵 Fukuoka prefecture, Japan

S114.3.117 Kashi shinryo Clinic; 🇯🇵 Fukuoka prefecture, Japan

S114.3.117 Kashii Sanatorium; 🇯🇵 Fukuoka prefecture, Japan

S114.3.117 Sugahara Tenjin Hospital; 🇯🇵 Fukuoka prefecture, Japan

S114.3.117 Goryokai Hospital; 🇯🇵 Hokkaido prefecture, Japan

S114.3.117 National Hospital Organization Sakakiba; 🇯🇵 Mie prefecuture, Japan

S114.3.117 Tokushima University Hospital; 🇯🇵 Tokushima prefecture, Japan

S114.3.117 Shiranui Hospital; 🇯🇵 Fukuoka prefecture, Japan

S114.3.117 Hatakeyama Clinic; 🇯🇵 Fukuoka prefecture, Japan

S114.3.117 Nagoya Mental Clinic; 🇯🇵 Nagoya prefecture, Japan

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

S114.3.117 Shinshu University Hospital; 🇯🇵 Nagano prefecture, Japan

S114.3.117 Kaname Clinic; 🇯🇵 Fukuoka prefecture, Japan

S114.3.117 National Hospital Organization Kagawa C; 🇯🇵 Kagawa prefecture, Japan

S114.3.117 Nara Medical University Hospital; 🇯🇵 Nara prefecture, Japan

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

S114.3.117 Kyushu University Hospital; 🇯🇵 Fukuoka prefecture, Japan

S114.3.117 Yokohama City University Hospital; 🇯🇵 Kanagawa Prefecture, Japan

S114.3.117 Kobe University Hospital; 🇯🇵 Hyogo prefecture, Japan

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