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Completed

NCT Number: NCT00353028

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

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

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

S114.3.117 Kohnodai Hospital, National Center of N, Chiba Prefecture, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluvoxamine maleate

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. 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

Secondary outcomes

  1. The Clinical Global Impression(CGI) improvement at Week 8

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jul 17, 2006
Registry last updated
Mar 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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