Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3 Study of SME3110 (Fluvoxamine Maleate) in Pediatric/Adolescent Subjects With Obsessive Compulsive Disorder
Brief Summary:
The objective in 1st phase of this randomized study is to evaluate the efficacy of SME3110 compared to placebo on change in total score of Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale 10-item for children from baseline to the last observation visit in pediatric/adolescent Obsessive Compulsive Disorder subjects in short-term (10 weeks) in double blind period. The safety of SME3110 compared to placebo is also evaluated.
The objective in 2nd phase of the study is to evaluate the long-term safety and efficacy of SME3110 in pediatric/adolescent Obsessive Compulsive Disorder subjects.