Obsessive Compulsive Disorder (OCD)
Conditions
Keywords
Transcranial magnetic stimulation (TMS), Cognitive behavioral therapy (CBT)
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.
Interventions
DEVICETranscranial magnetic stimulation
BEHAVIORALCognitive behavioral therapy
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study: 1. All subjects will be 18 - 65 years of age. 2. Obsessive-compulsive disorder: * Subjects will meet the DSM-IV primary diagnosis of obsessive-compulsive * Y-BOCS total score \> 16 3. Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.
Exclusion criteria
Subjects will be excluded from study participation if one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complete Response, as Measured by Y-BOCS | 6 weeks | Complete response is defined as a reduction of Y-BOCS score greater than 35%. |
| Partial Response Rate, as Measured by Y-BOCS | 6 weeks | Partial response is defined as a reduction of greater than 25%. |
| Percentage of Adverse Events | 6 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| rTMS and Cognitive Behavior Therapy Transcranial magnetic stimulation
Cognitive behavioral therapy | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | rTMS and Cognitive Behavior Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 51.5 years |
| Gender Female | 1 Participants |
| Gender Male | 1 Participants |
| Region of Enrollment United States | 2 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Remission Rate, as Measured by Y-BOCS
Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rTMS and Cognitive Behavior Therapy | Remission Rate, as Measured by Y-BOCS | 50 percentage of participants |
Secondary
Complete Response, as Measured by Y-BOCS
Complete response is defined as a reduction of Y-BOCS score greater than 35%.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rTMS and Cognitive Behavior Therapy | Complete Response, as Measured by Y-BOCS | 50 percentage of participants |
Secondary
Partial Response Rate, as Measured by Y-BOCS
Partial response is defined as a reduction of greater than 25%.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rTMS and Cognitive Behavior Therapy | Partial Response Rate, as Measured by Y-BOCS | 50 percentage of participants |
Secondary
Percentage of Adverse Events
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| rTMS and Cognitive Behavior Therapy | Percentage of Adverse Events | 0 percentage of adverse events |