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

Study Primary Completion Date: March 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 (maximum:6 tablets), the study medication will orally be administered twice daily, after breakfast and at bedtime. Duration: 8 weeks.
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: F
• Placebo Comparator: P

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 10
  • Time Frame: 8 weeks
    Safety Issue?: No

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

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Overall Contact: Toshiaki Yamaguchi  Toshiaki.Yamaguchi@solvay.com

Information obtained from ClinicalTrials.gov on November 19, 2008

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