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| Sponsor: | University of Florida |
|---|---|
| Collaborator: |
Ortho-McNeil Pharmaceutical |
| Information provided by (Responsible Party): | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00187928 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive-Compulsive Disorder |
Drug: Topiramate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind 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 |
| Estimated Enrollment: | 96 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
If female, the subject must:
Exclusion Criteria:
Subjects known to have clinically significant medical conditions, including but not limited to:
Contacts and Locations| United States, Florida | |
| UF Health Science Center | |
| Gainesville, Florida, United States, 32608 | |
| Principal Investigator: | Herbert E Ward, MD | University of Florida |
More Information
| Responsible Party: | University of Florida |
| ClinicalTrials.gov Identifier: | NCT00187928 History of Changes |
| Other Study ID Numbers: | CAPSS-217 |
| Study First Received: | September 15, 2005 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Obsessive-Compulsive Disorder Obsessions Compulsions Adjunctive treatment |
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders Topiramate Anticonvulsants Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |