Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Icahn School of Medicine at Mount Sinai.
Recruitment status was  Recruiting
Ortho-McNeil Pharmaceutical
Information provided by:
Icahn School of Medicine at Mount Sinai Identifier:
First received: September 13, 2005
Last updated: September 5, 2008
Last verified: December 2005
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

Resource links provided by NLM:

Further study details as provided by Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • 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
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00211744

Contact: Kim Suah (212)369-5123
Contact: Jade Rusoff, BA 212-241-3692

United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Kim Suah    212-369-5123   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Ortho-McNeil Pharmaceutical
Principal Investigator: Erik Hollander, MD Icahn School of Medicine at Mount Sinai
  More Information

Additional Information:
No publications provided by Icahn School of Medicine at Mount Sinai

Additional publications automatically indexed to this study by Identifier (NCT Number): 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 Icahn School of Medicine at Mount Sinai:
Obsessive-Compulsive Disorder
OCD treatment

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders
Anti-Obesity Agents
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on November 27, 2015