Overview

A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder

Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
The objective of the first phase of this study is to evaluate the efficacy of fluvoxamine compared to placebo on change in total score of Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item from baseline to the last observation visit (10 weeks) in pediatric/adolescent participants with obsessive compulsive disorder (OCD). The objective of the second phase of the study is to evaluate the long-term safety and efficacy of fluvoxamine in pediatric/adolescent patients with OCD.
Phase:
Phase 3
Details
Lead Sponsor:
AbbVie
Collaborator:
Meiji Seika Pharma Co., Ltd.
Treatments:
Fluvoxamine
Maleic acid