Back to resultsTopiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-compulsive Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
topiramate
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-compulsive Disorder focused on measuring OCD, Obsessive-Compulsive Disorder, OCD treatment
Eligibility 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
Sites / Locations
- Mount Sinai School of Medicine
Outcomes
Primary Outcome Measures
To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD
Secondary Outcome Measures
Full Information
NCT ID
NCT00211744
First Posted
September 13, 2005
Last Updated
May 25, 2018
Sponsor
Montefiore Medical Center
Collaborators
Ortho-McNeil Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00211744
Brief Title
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Official Title
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Ortho-McNeil Pharmaceutical
4. Oversight
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
Keywords
OCD, Obsessive-Compulsive Disorder, OCD treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
topiramate
Primary Outcome Measure Information:
Title
To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Hollander, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20816027
Citation
Berlin HA, Koran LM, Jenike MA, Shapira NA, Chaplin W, Pallanti S, Hollander E. Double-blind, placebo-controlled trial of topiramate augmentation in treatment-resistant obsessive-compulsive disorder. J Clin Psychiatry. 2011 May;72(5):716-21. doi: 10.4088/JCP.09m05266gre. Epub 2010 Aug 10.
Results Reference
derived
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Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder
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