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

Verified by: Solvay Pharmaceuticals, March 2010
First Received: July 14, 2006 | Last Updated: March 3, 2010 | Phase: Phase 4 | Start Date: October 2006
Overall Status: Completed | Estimated Enrollment: 90
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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...

Brief Summary

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”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

  • 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 (maximam:6 tablets), the study mmedica
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: F
  • Placebo Comparator: P

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
    • Time Frame: 8 weeks
      Safety Issue?: No

Secondary Measures

  • The Clinical Global Impression(CGI) improvement at Week 8
    • Time Frame: 8 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

  • 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 8 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Solvay Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Toshiaki Yamaguchi Study Director Solvay Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00353028

Study ID Number: S114.3.117

ClinicalTrials.gov Identifier: NCT00353028

Health Authority: Japan: Ministry of Health, Labor and Welfare

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