Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study

Not Applicable

Terminated

• Conditions: Obsessive Compulsive Disorder (OCD)
• Interventions: Device: Transcranial magnetic stimulation; Behavioral: Cognitive behavioral therapy

• Registration Number: NCT02528331
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-19
• Study Start: 2016-03
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Status Verified: 2016-11
• Results First Submitted: 2016-11-29
• Results First Submitted QC: 2016-12-19
• Last Update Submitted: 2016-12-19
• Results First Posted: 2017-02-09
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rTMS and Cognitive Behavior Therapy	Cognitive behavioral therapy	-
rTMS and Cognitive Behavior Therapy	Transcranial magnetic stimulation	-

Primary Outcome Measures

Name	Time	Method
Remission Rate, as Measured by Y-BOCS	6 weeks	Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.

Secondary Outcome Measures

Name	Time	Method
Percentage of Adverse Events	6 weeks
Partial Response Rate, as Measured by Y-BOCS	6 weeks	Partial response is defined as a reduction of greater than 25%.
Complete Response, as Measured by Y-BOCS	6 weeks	Complete response is defined as a reduction of Y-BOCS score greater than 35%.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States