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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353028

Enrollment

Registered

2006-07-17

Start date

2006-10-31

Completion date

2009-07-31

Last updated

2010-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Fluvoxamine Maleate, Depression, Children and Adolescents

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

Interventions

DRUGFluvoxamine 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

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The Clinical Global Impression(CGI) improvement at Week 8	8 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026