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

Obsessive Compulsive Disorder Clinical Trial

Official title:
A Phase 3 Study of SME3110 (Fluvoxamine Maleate) in Pediatric/Adolescent Subjects With Obsessive Compulsive Disorder

Clinical Trial 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.

Clinical Trial Description

The first phase will be conducted in a randomized, placebo-controlled, double-blind manner to evaluate the efficacy of fluvoxamine on change from baseline to the last observation visit in the JCY-BOCS 10-item total score. Eligible patients will be allocated to the fluvoxamine group or placebo group in a 1:1 ratio using the experience of fluvoxamine treatment and age as stratification factors (dynamic allocation). The first phase consists of a screening period of 1-2 weeks, a forced titration dose period of 2 weeks, a dose adjustment period of 4 weeks, a maintained dose period of 4 weeks, and a tapering dose period of 0-4 weeks.

The 2nd phase will be conducted in an open-label manner in participants who completed the first phase to evaluate the long-term safety of fluvoxamine. The 2nd phase consists of 3 periods; a forced titration dose period of 2 weeks, a flexible dose period of 50 weeks, and a tapering dose period of 0-4 weeks. After the last dose of study drug (including tapering dose period) or the early termination visit, participants will be followed for up to 30 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01933919
Study type Interventional
Source AbbVie
Contact
Status Completed
Phase Phase 3
Start date August 14, 2013
Completion date July 1, 2016
View Details
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