Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder
The purpose of this study is to determine if a drug called topiramate is safe and effective as an add-on therapy in the treatment of Obsessive-Compulsive Disorder (OCD). Topiramate is an investigational drug for OCD, which means it has not been approved by the U.S. Food and Drug Administration (FDA). Topiramate has been approved as an add-on therapy for adults and children with partial onset seizures or generalized tonic-clonic seizures, and for patients 2 years of age and older with a severe form of epilepsy called Lennox-Gastaut Syndrome.
Up to 96 subjects will be enrolled in this study. This study consists of three phases: Washout/Screening Phase, Double-Blind Phase, and Taper Phase. The total expected length of your participation in the study is approximately four months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder|
|Study Start Date:||January 2003|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
This is a multicenter, outpatient, randomized, double-blind, placebo-controlled, parallel-group, study designed to evaluate the safety and efficacy of adjunctive topiramate in treating subjects with OCD. The study consists of a washout/screening phase, a double-blind treatment phase of 12 weeks, a taper period of approximately 7 days. Upon successful completion of the washout/screening phase subjects will be randomized into 1 of 2 treatment groups: topiramate up to 400 mg/day or placebo. A placebo control will be used to establish the frequency and magnitude of changed in clinical endpoints that may occur in the absence of active treatment.
During the double-blind phase, subjects will be seen weekly for the first two weeks and then every other week for the remainder of the double-blind phase. Study medication will be titrated over the 8-week titration period up to 400mg/day or the subject's maximum tolerated dose. After the titration period, the dose will remain stable for the maintenance period during which visits will occur every 14 days. At the completion of the maintenance period, subjects will taper their study medication over the next 7 days.
This study will be conducted in up to 96 subjects with a diagnosis of OCD with an onset at least 1 year prior to screening supported by the SCID-I. Forty-eight subjects will be assigned to topiramate and 48 will be assigned to placebo.
|United States, Florida|
|UF Health Science Center|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Herbert E Ward, MD||University of Florida|