Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Montefiore Medical Center
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD
Study Overview
Brief Summary
A 12-week program to examine the effectiveness of topiramate in adjunctive treatment for adults with obsessive-compulsive disorder and who are currently on serotonin reuptake inhibitor medications (ages 18-65).
Detailed Description
The Compulsive, Impulsive and Anxiety Disorders Program at the Mount Sinai School of Medicine is conducting a study of Topiramate (Topamax) added to an SSRI for the management of treatment-resistant Obsessive-Compulsive Disorder. The purpose of the study is to evaluate the safety and efficacy of Topiramate versus placebo added to a selective serotonin reuptake inhibitor (SRI) in patients with treatment resistant OCD. The program is 12 weeks in duration and involves regular visits with a psychiatrist as well as complete psychiatric and medical evaluations. Treatment and medication for the study will be provided free of charge.Participants must be between the ages of 18 and 65 and have an onset of OCD at least 1 year prior to screening. In addition, participants must be taking a clinically effective dose of an SSRI for at least 3 months and must maintain their current dose throughout the study. Participants must not have a primary OCD symptom of hoarding.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and Females 18-65 years of age diagnosed with OCD and currently taking SSRI medication(s)
Exclusion Criteria
- •major medical disorders
Outcomes
Primary Outcomes
To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD
Secondary Outcomes
No secondary outcomes reported
Investigators
Eric Hollander
Principal Investigator
Montefiore Medical Center