Trigeminal Nerve Stimulation for Depression: Dose Finding

Completed · Phase 2

Conditions studied: Depression

In brief

This study will aim to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) when added onto antidepressant medications. Our primary objective is the examination of two different "doses" of TNS, in terms of pulse frequency. To accomplish our specific aims, the investigators will test the following specific hypotheses: 1. Subjects will show greater improvement in ratings of mood and other symptoms of depression during the six-week of high frequency stimulation than during low frequency stimulation periods. 2. Subjects will show greater improvement after 12 weeks of high frequency stimulation than after six weeks of high frequency stimulation. 3. Subjects will show improvement in ratings of life functional capacity and quality of life with TNS. 4. Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device. 5. Subjects will show significant differences in regional brain function at the end of the high frequency stimulation period compared with baseline, and significant differences between high and low frequency stimulation conditions.

Key facts

Study ID

NCT01343563

Run by

University of California, Los Angeles

People needed

20

Starts

2011-01-01

Expected to finish

2012-01-01

Last updated by the study team

2013-02-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the MINI structured interview
• A score of ≥ 14 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
• 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 65 years old.
• 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); post-traumatic stress disorder within the past year; 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

Where it is running

• Semel Institute for Neuroscience and Human Behavior at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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