Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01335217
• Date of registration: 05/04/2011
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Trigeminal Nerve Stimulation for Post Traumatic Stress Disorder (PTSD) and Depression
• Scientific title: Trigeminal Nerve Stimulation for PTSD and Depression
• Date of first enrolment: January 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01335217
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Ian A Cook, M.D.
• Affiliation: Semel Institute for Neuroscience and Human Behavior

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Post-traumatic Stress Disorder

Intervention(s)

Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)

Primary Outcome(s)

Change in Hamilton Depression Rating Scale-17 Item [Time Frame: Baseline, week 8]

Change in PTSD Checklist score [Time Frame: Baseline, Week 8]

Secondary Outcome(s)

Change in life functional capacity and quality of life scales [Time Frame: baseline, week 8]

Changes in Safety Assessment Measures [Time Frame: At every visit for 8 weeks]

Changes in vital signs recordings [Time Frame: At every visit for 8 weeks]

Secondary ID(s)

10-000894

Source(s) of Monetary Support

Please refer to primary and secondary sponsors