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| Sponsors and Collaborators: |
Mount Sinai School of Medicine Ortho-McNeil Pharmaceutical |
|---|---|
| Information provided by: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00211744 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive-Compulsive Disorder |
Drug: topiramate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder |
| Estimated Enrollment: | 24 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | August 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Kim Suah | (212)369-5123 | suah.kim@mssm.edu |
| Contact: Jade Rusoff, BA | 212-241-3692 | jad.rusoff@mssm.edu |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Kim Suah 212-369-5123 suah.kim@mssm.edu | |
| Principal Investigator: | Erik Hollander, MD | Mount Sinai School of Medicine |
More Information
| Study ID Numbers: | 04-0379 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00211744 |
| Health Authority: | United States: Food and Drug Administration |
|
OCD Obsessive-Compulsive Disorder OCD treatment |
|
Anxiety Disorders Mental Disorders Topiramate Obsessive-Compulsive Disorder |
|
Anti-Obesity Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |
