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

Solvay

Status and phase: Terminated; Phase 4

Conditions: Obsessive Compulsive Disorder

Treatments: Drug: Fluvoxamine maleate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00352768

S114.3.118

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

F

Experimental group

Treatment:

Drug: Fluvoxamine maleate

P

Placebo Comparator group

Treatment:

Drug: Placebo