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Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

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ClinicalTrials.gov Identifier: NCT00211744
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
Ortho-McNeil Pharmaceutical
Information provided by (Responsible Party):
Eric Hollander, Montefiore Medical Center

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).

Condition or disease Intervention/treatment Phase
Obsessive-compulsive Disorder Drug: topiramate Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Study Start Date : August 2004
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Topiramate




Primary Outcome Measures :
  1. To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211744


Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Montefiore Medical Center
Ortho-McNeil Pharmaceutical
Investigators
Principal Investigator: Erik Hollander, MD Icahn School of Medicine at Mount Sinai

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eric Hollander, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00211744     History of Changes
Other Study ID Numbers: 04-0379
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018

Keywords provided by Eric Hollander, Montefiore Medical Center:
OCD
Obsessive-Compulsive Disorder
OCD treatment

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents