NCT00353028

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Solvay Pharmaceuticals · Industry
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-07-17
• Last updated: 2010-03-04

Locations

25 sites across 1 country: Japan