Clinical trial NCT01335217: Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression
Official title: Trigeminal Nerve Stimulation for PTSD and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Post-traumatic Stress Disorder
Keywords: Depression
Major Depressive Disorder (MDD)
Trigeminal Nerve Stimulation
Post Traumatic Stress Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2011-04-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

1. Outpatients with non-psychotic, unipolar Major Depressive Disorder AND Posttraumatic Stress Disorder, assessed via the MINI structured interview
2. A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
3. A score of ≥ 50 on the CAPS (Clinical-Administered PTSD Scale for DSM-IV)
4. A history of treatment failure with at least one adequate trial of an antidepressant over the previous 6 weeks, with no change in antidepressant medication or dose within the previous 6 weeks, and ongoing use of at least one antidepressant (which will continue during participation in the study)
5. Age range: 18 to 75. 6) Patients with suicidal ideation are eligible only if the thoughts of death or of life not being worth living are not accompanied by a plan or intention for self-harm.

Exclusion Criteria

1. Patient is mentally or legally incapacitated, unable to give informed consent.
2. Patients with psychosis (psychotic depression, schizophrenia, or schizoaffective diagnoses (lifetime)); bipolar disorder (lifetime); dementia (lifetime); delirium or any substance abuse disorder within the past 6 months; eating disorder within the past year; obsessive- compulsive disorder (lifetime); acute risk for suicide or self-injurious behavior. Patients with diagnostic uncertainty or ambiguity (e.g. rule-out pseudodementia of depression) will be excluded.
3. Patients with exposure to ECT or VNS within the past 6 months.
4. Past history of skull fracture; cranial surgery entering the calvarium; space occupying intracranial lesion; stroke, CVA, or TIAs; cerebral aneurysm; Parkinson's or Huntington's disease; or Multiple Sclerosis.
5. current pregnancy, breast feeding, plans to become pregnant in the 12-week treatment phase of the study, or not using a medically accepted means of contraception.
6. Other medical contraindications to any of the study procedures

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale-17 Item
timeFrame: Baseline, week 8
measure: Change in PTSD Checklist score
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change in life functional capacity and quality of life scales
timeFrame: baseline, week 8
measure: Changes in vital signs recordings
timeFrame: At every visit for 8 weeks
measure: Changes in Safety Assessment Measures
timeFrame: At every visit for 8 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Semel Institute for Neuroscience and Human Behavior at UCLA
state: California
Study officials:
affiliation: Semel Institute for Neuroscience and Human Behavior
name: Ian A Cook, M.D.
role: PRINCIPAL_INVESTIGATOR
References: