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

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.

Timeline

Start

2013-08-14

Primary completion

2015-06-18

Completion

2016-07-01

Outcome

Met primary endpoint

registry analysis (superiority test); Fluvoxamine vs Placebo; p = 0.044; LS Mean Difference (Fluvoxamine-Placebo) -4.3 (95% CI -8.5 to -0.1); ANCOVA NCT01933919 ↗

Drugs

Indications