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

Primary Purpose

Depression, Post-traumatic Stress Disorder

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Transcutaneous Electrical Nerve Stimulator (TENS)

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Major Depressive Disorder (MDD), Trigeminal Nerve Stimulation, Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Outpatients with non-psychotic, unipolar Major Depressive Disorder AND Posttraumatic Stress Disorder, assessed via the MINI structured interview
A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
A score of ≥ 50 on the CAPS (Clinical-Administered PTSD Scale for DSM-IV)
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)
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

Patient is mentally or legally incapacitated, unable to give informed consent.
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.
Patients with exposure to ECT or VNS within the past 6 months.
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.
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.
Other medical contraindications to any of the study procedures

Sites / Locations

Semel Institute for Neuroscience and Human Behavior at UCLA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-label TNS treatment

Arm Description

There is only one arm in this open label treatment of MDD co-occuring with PTSD.

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Rating Scale-17 Item

Change in PTSD Checklist score

Secondary Outcome Measures

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

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.

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)

Full Information

NCT ID

NCT01335217

First Posted

April 5, 2011

Last Updated

February 4, 2013

Sponsor

University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT01335217

Brief Title

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

Official Title

Trigeminal Nerve Stimulation for PTSD and Depression

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

4. Oversight

Data Monitoring Committee

5. Study Description

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: Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Post-traumatic Stress Disorder

Keywords

Depression, Major Depressive Disorder (MDD), Trigeminal Nerve Stimulation, Post Traumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Open-label TNS treatment

Arm Type

Other

Arm Description

There is only one arm in this open label treatment of MDD co-occuring with PTSD.

Intervention Type

Procedure

Intervention Name(s)

Transcutaneous Electrical Nerve Stimulator (TENS)

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Hamilton Depression Rating Scale-17 Item

Time Frame

Baseline, week 8

Title

Change in PTSD Checklist score

Time Frame

Baseline, Week 8

Secondary Outcome Measure Information:

Title

Change in life functional capacity and quality of life scales

Description

Life functional capacity and quality of life scales include: Short-form Health Survey-36 Item and Quality of Life Enjoyment and Satisfaction Questionnaire

Time Frame

baseline, week 8

Title

Changes in vital signs recordings

Description

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.

Time Frame

At every visit for 8 weeks

Title

Changes in Safety Assessment Measures

Description

Time Frame

At every visit for 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Outpatients with non-psychotic, unipolar Major Depressive Disorder AND Posttraumatic Stress Disorder, assessed via the MINI structured interview A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2 A score of ≥ 50 on the CAPS (Clinical-Administered PTSD Scale for DSM-IV) 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) 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 Patient is mentally or legally incapacitated, unable to give informed consent. 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. Patients with exposure to ECT or VNS within the past 6 months. 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. 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. Other medical contraindications to any of the study procedures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ian A Cook, M.D.

Organizational Affiliation

Semel Institute for Neuroscience and Human Behavior

Official's Role

Principal Investigator

Facility Information:

Facility Name

Semel Institute for Neuroscience and Human Behavior at UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

12. IPD Sharing Statement

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

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