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 Mount Sinai School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ortho-McNeil Pharmaceutical
Information provided by:
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00211744
First received: September 13, 2005
Last updated: September 5, 2008
Last verified: December 2005
  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

Resource links provided by NLM:


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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211744

Contacts
Contact: Kim Suah (212)369-5123 suah.kim@mssm.edu
Contact: Jade Rusoff, BA 212-241-3692 jad.rusoff@mssm.edu

Locations
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   
Sponsors and Collaborators
Mount Sinai School of Medicine
Ortho-McNeil Pharmaceutical
Investigators
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
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality 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 April 22, 2014