Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Recruitment status was Recruiting
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder |
- To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD
| 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
Additional Information:
No publications provided by Mount Sinai School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00211744 History of Changes |
| Other Study ID Numbers: | 04-0379 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 5, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Mount Sinai School of Medicine:
|
OCD Obsessive-Compulsive Disorder OCD treatment |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 16, 2013