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NCT00211744 Clinical Trial

Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

Obsessive-compulsive Disorder Clinical Trial

Official title:
Topiramate Augmentation in the Treatment of Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00211744
Other study ID # 04-0379
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2004
Est. completion date August 2006

Study information
Verified date May 2018
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

Males and Females 18-65 years of age diagnosed with OCD and currently taking SSRI medication(s)

Exclusion Criteria:

major medical disorders

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• topiramate

Locations
Country Name City State
United States Mount Sinai School of Medicine New York New York

Sponsors (2)
Lead Sponsor Collaborator
Montefiore Medical Center Ortho-McNeil Pharmaceutical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and efficacy of adjunctive topiramate vs. placebo in the treatment of OCD
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