Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Sponsor
- Duke University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Remission Rate, as Measured by Y-BOCS
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effectiveness of repetitive TMS (rTMS) delivered simultaneously with elements of cognitive behavioral therapy/exposure-response prevention (CBT/ERP) in adult subjects (greater or equal to 18 years old) with obsessive-compulsive disorder (OCD). This is an open label study that involves standard of care for OCD (CBT) and an investigational treatment modality (TMS). The investigators will compare the Yale-Brown Obsessive Compulsive Scale (YBOCS) scores before and after treatment to quantify clinical improvement. The side effects from TMS include, but are not limited to, headache, seizure, and general pain. CBT has minimal side effects other than mental discomfort during the exposure sessions. For safety concerns, pregnant women and subjects with seizure-related history will be excluded as well as other indicated conditions in the details protocol.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Remission Rate, as Measured by Y-BOCS
Time Frame: 6 weeks
Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.
Secondary Outcomes
- Percentage of Adverse Events(6 weeks)
- Partial Response Rate, as Measured by Y-BOCS(6 weeks)
- Complete Response, as Measured by Y-BOCS(6 weeks)