Trigeminal Nerve Stimulation for Depression: Dose Finding

NCT01343563 | Completed Phase 2

• 1 other identifier: 10-000480
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Subjects will show greater improvement after 12 weeks of high frequency stimulation than after six weeks of high frequency stimulation.
3. 3.Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
4. 4.Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
5. 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.

Conditions

Depression

Keywords

Depression; Major Depressive Disorder (MDD); EEG; Trigeminal Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Depression Rating Scale 17 score

  baseline, week 6, week 12

Secondary Outcomes (4)

• Change in life functional capacity and quality of life scales

  baseline, week 6, week 12

• Changes in Regional Brain Function

  baseline, week 6, week 12

• Changes in vital signs recordings

  At every visit for 12 weeks

• Changes in Safety Assessment Measures

  At every visit for 12 weeks

Study Arms (2)

Low frequency to High

ACTIVE COMPARATOR

For the first six weeks, subjects randomized to this group will receive low frequency stimulation. At the six week point, the low frequency group subjects will be crossed over to high frequency for the remaining six weeks.

Procedure: Trigeminal Nerve Stimulation

High frequency

ACTIVE COMPARATOR

Subjects randomized to this group will receive high frequency stimulation for the entire 12 weeks of the first phase of this study.

Procedure: Trigeminal Nerve Stimulation

Interventions

Trigeminal Nerve Stimulation PROCEDURE

External trigeminal nerve stimulation (TNS) as an adjunctive treatment added onto antidepressant medications.

High frequency; Low frequency to High

Eligibility Criteria

• Age: 18 Years - 65 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 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

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; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ian A Cook, MD

  Semel Institute for Neuroscience and Human Behavior

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 28, 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)