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

SME3110 (Fluvoxamine Maleate) in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placebo-controlled Study

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00352768
Enrollment
20
Registered
2006-07-17
Start date
2006-08-31
Completion date
2009-04-30
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

Obsessive Compulsive Disorder

Keywords

Fluvoxamine Maleate, OCD, Children and Adolescents

Brief summary

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

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

Sponsors

Solvay Pharmaceuticals
Lead SponsorINDUSTRY

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
No

Inclusion criteria

Have a minimum total score of 16 on the JCY-BOCS, 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

MeasureTime frame
the time of onset of 25% decrease from baseline in the Japanese Version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item total score10 weeks

Secondary

MeasureTime frame
The Clinical Global Impression(CGI) improvement at Week 1010 weeks

Countries

Japan

Outcome results

None listed

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