Depression Clinical Trial
Official title:
Trigeminal Nerve Stimulation for PTSD and Depression
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:
1. Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the
eight-week period.
2. Subjects will show improvement in ratings of life functional capacity and quality of
life with TNS.
3. Subjects will report the TNS treatments to be acceptable in terms of side effects and
burden of using the device.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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