Trial Outcomes & Findings for Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study (NCT NCT02528331)

Results Overview

Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	rTMS and Cognitive Behavior Therapy Transcranial magnetic stimulation Cognitive behavioral therapy
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	rTMS and Cognitive Behavior Therapy Transcranial magnetic stimulation Cognitive behavioral therapy
Overall Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rTMS and Cognitive Behavior Therapy n=2 Participants Transcranial magnetic stimulation Cognitive behavioral therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51.5 years n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.

Outcome measures

Outcome measures
Measure	rTMS and Cognitive Behavior Therapy n=2 Participants Transcranial magnetic stimulation Cognitive behavioral therapy
Remission Rate, as Measured by Y-BOCS	50 percentage of participants

SECONDARY outcome

Timeframe: 6 weeks

Complete response is defined as a reduction of Y-BOCS score greater than 35%.

Outcome measures

Outcome measures
Measure	rTMS and Cognitive Behavior Therapy n=2 Participants Transcranial magnetic stimulation Cognitive behavioral therapy
Complete Response, as Measured by Y-BOCS	50 percentage of participants

SECONDARY outcome

Timeframe: 6 weeks

Partial response is defined as a reduction of greater than 25%.

Outcome measures

Outcome measures
Measure	rTMS and Cognitive Behavior Therapy n=2 Participants Transcranial magnetic stimulation Cognitive behavioral therapy
Partial Response Rate, as Measured by Y-BOCS	50 percentage of participants

SECONDARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	rTMS and Cognitive Behavior Therapy n=2 Participants Transcranial magnetic stimulation Cognitive behavioral therapy
Percentage of Adverse Events	0 percentage of adverse events

Adverse Events

rTMS and Cognitive Behavior Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Weiner, MD, PhD

Duke University

Phone: 919-681-8742

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place