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

Depression Clinical Trial

Official title:

Trigeminal Nerve Stimulation for PTSD and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335217
• Other study ID #: 10-000894
• Secondary ID: 10-000894
• Status: Completed
• Phase: Phase 1
• First received: April 5, 2011
• Last updated: February 4, 2013
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: February 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Transcutaneous Electrical Nerve Stimulator (TENS)
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

Locations

Country	Name	City	State
United States	Semel Institute for Neuroscience and Human Behavior at UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hamilton Depression Rating Scale-17 Item		Baseline, week 8	No
Primary	Change in PTSD Checklist score		Baseline, Week 8	No
Secondary	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	No
Secondary	Changes in vital signs recordings	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	Yes
Secondary	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	Yes