Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents

NCT ID: NCT00352768

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-04-30

Brief Summary

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This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder

Detailed Description

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Conditions

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Obsessive Compulsive 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 16 on the JCY-BOCS, 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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S114.3.118 Kohnodai Hospital, National Center of N

Chiba Prefecture, , Japan

Site Status

S114.3.118 Kyushu University Hospital

Fukuoka Prefecture, , Japan

Site Status

S114.3.118 Hiroshima-city Funairi Hospital

Hiroshima Prefecture, , Japan

Site Status

S114.3.118 Goryokai Hospital

Hokkaido Prefecture, , Japan

Site Status

S114.3.118 Hyogo Children's Hospital

Hyogo Prefecture, , Japan

Site Status

S114.3.118 Kobe University Hospital

Hyogo Prefecture, , Japan

Site Status

S114.3.118 National Hospital Organization Kagawa C

Kagawa Prefecture, , Japan

Site Status

S114.3.118 National Hospital Organization Kikuti N

Kumamoto Prefecture, , Japan

Site Status

S114.3.118 National Hospital Organization Sakakiba

Mie Prefecuture, , Japan

Site Status

S114.3.118 Nara Medical University Hospital

Nara Prefecture, , Japan

Site Status

S114.3.118 Tokushima University Hospital

Tokushima Prefecture, , Japan

Site Status

Countries

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Japan

Other Identifiers

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S114.3.118

Identifier Type: -

Identifier Source: org_study_id

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