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

NCT ID: NCT00353028

Last Updated: 2010-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-07-31

Brief Summary

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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 state

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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F

Group Type EXPERIMENTAL

Fluvoxamine maleate

Intervention Type 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

P

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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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

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria Have a minimum total score of 18 on the JSIGH-D, Weight is within the standard weight ± 2S.D.

Exclusion Criteria

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
Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Toshiaki Yamaguchi

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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S114.3.117 Kohnodai Hospital, National Center of N

Chiba Prefecture, , Japan

Site Status

S114.3.117 Fukuoka University Hospital

Fukuoka Prefecture, , Japan

Site Status

S114.3.117 Hatakeyama Clinic

Fukuoka Prefecture, , Japan

Site Status

S114.3.117 Kaname Clinic

Fukuoka Prefecture, , Japan

Site Status

S114.3.117 Kashi shinryo Clinic

Fukuoka Prefecture, , Japan

Site Status

S114.3.117 Kashii Sanatorium

Fukuoka Prefecture, , Japan

Site Status

S114.3.117 Kyushu University Hospital

Fukuoka Prefecture, , Japan

Site Status

S114.3.117 Shiranui Hospital

Fukuoka Prefecture, , Japan

Site Status

S114.3.117 Sugahara Tenjin Hospital

Fukuoka Prefecture, , Japan

Site Status

S114.3.117 Hiroshima-city Funairi Hospital

Hiroshima Prefecture, , Japan

Site Status

S114.3.117 Goryokai Hospital

Hokkaido Prefecture, , Japan

Site Status

S114.3.117 Kobe University Hospital

Hyogo Prefecture, , Japan

Site Status

S114.3.117 National Hospital Organization Kagawa C

Kagawa Prefecture, , Japan

Site Status

S114.3.117 Yokohama City University Hospital

Kanagawa Prefecture, , Japan

Site Status

S114.3.117 National Hospital Organization Kikuti N

Kumamoto Prefecture, , Japan

Site Status

S114.3.117 Kyoto University Hospital

Kyoto Prefecture, , Japan

Site Status

S114.3.117 National Hospital Organization Sakakiba

Mie Prefecuture, , Japan

Site Status

S114.3.117 Shinshu University Hospital

Nagano Prefecture, , Japan

Site Status

S114.3.117 Aichi Children's Health and Medical Cen

Nagoya Prefecture, , Japan

Site Status

S114.3.117 Nagoya Mental Clinic

Nagoya Prefecture, , Japan

Site Status

S114.3.117 Nara Medical University Hospital

Nara Prefecture, , Japan

Site Status

S114.3.117 Kansai Medical University Takii Hospita

Osaka Prefecture, , Japan

Site Status

S114.3.117 Kusube Clinic

Osaka Prefecture, , Japan

Site Status

S114.3.117 Yasuhara Children's Clinic

Osaka Prefecture, , Japan

Site Status

S114.3.117 Tokushima University Hospital

Tokushima Prefecture, , Japan

Site Status

Countries

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Japan

Other Identifiers

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S114.3.117

Identifier Type: -

Identifier Source: org_study_id

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