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

NCT01335217 | Completed Phase 1

• 1 other identifier: 10-000894
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period.
2. 2.Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
3. 3.Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.

Conditions

Depression; Post-traumatic Stress Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Hamilton Depression Rating Scale-17 Item

  Baseline, week 8

• Change in PTSD Checklist score

  Baseline, Week 8

Secondary Outcomes (3)

• Change in life functional capacity and quality of life scales

  baseline, week 8

• Changes in vital signs recordings

  At every visit for 8 weeks

• Changes in Safety Assessment Measures

  At every visit for 8 weeks

Study Arms (1)

Open-label TNS treatment

OTHER

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

Procedure: Transcutaneous Electrical Nerve Stimulator (TENS)

Interventions

Transcutaneous Electrical Nerve Stimulator (TENS) PROCEDURE

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

Open-label TNS treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Semel Institute for Neuroscience and Human Behavior at UCLA

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Ian A Cook, M.D.

  Semel Institute for Neuroscience and Human Behavior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 14, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 6, 2013

Record last verified: 2013-02

Locations

US (1)