Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 10-000894 | Other Identifier | UCLA Medical IRB 3 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary objective is the examination of TNS in this patient population.
To accomplish our specific aims, the investigators will test the following specific hypotheses:
A total of 20 subjects with Major Depressive Disorder (MDD) co-occurring with Post Traumatic Stress Disorder (PTSD), ages 18 to 75 years, will be consented and join this project at UCLA.
The project will use TNS in under open-label conditions, using the same stimulation parameters as have been used in prior studies in MDD by itself and in treatment-refractory epilepsy. Subjects will be seen every two weeks during the 8 week study. At the end of the 8 weeks, the TNS systems will be returned and the adjunctive treatment will end. The co-primary endpoints are the changes in depression severity and in PTSD severity from enrollment to the week 8 visit.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label TNS treatment | Other | There is only one arm in this open label treatment of MDD co-occuring with PTSD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulator (TENS) | Procedure | External trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale-17 Item | Baseline, week 8 | |
| Change in PTSD Checklist score | Baseline, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in life functional capacity and quality of life scales | Life functional capacity and quality of life scales include: Short-form Health Survey-36 Item and Quality of Life Enjoyment and Satisfaction Questionnaire | baseline, week 8 |
| Changes in vital signs recordings |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ian A Cook, M.D. | Semel Institute for Neuroscience and Human Behavior | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semel Institute for Neuroscience and Human Behavior at UCLA | Los Angeles | California | 90024 | United States |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D013313 | Stress Disorders, Post-Traumatic |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Autonomic function (i.e. pulse and blood pressure) are monitored for 30 mins of stimulation at baseline. Resting vital signs are recorded for each visit. |
| At every visit for 8 weeks |
| Changes in Safety Assessment Measures | Safety Assessment measures will be administered at each visit and include: Survey of Acceptability of TNS, Systematic Assessment for Treatment Emergent Events-Systematic Inquiry (SAFTEE-SI), and Frequency, Intensity, and Burden of Side Effects Scale (FIBSER) | At every visit for 8 weeks |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |