Trigeminal Nerve Stimulation for Depression: Dose Finding

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01343563
• Date of registration: 05/04/2011
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Trigeminal Nerve Stimulation for Depression: Dose Finding
• Scientific title: Trigeminal Nerve Stimulation for Depression: Dose Finding
• Date of first enrolment: January 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01343563
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ian A Cook, MD
• Affiliation: Semel Institute for Neuroscience and Human Behavior

Key inclusion & exclusion criteria

Inclusion Criteria

1. Outpatients with non-psychotic, unipolar Major Depressive Disorder assessed via the
MINI structured interview

2. A score of = 14 on the HAM-D17 with Item 1 (depressed mood) = 2

3. 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)

4. Age range: 18 to 65 years old.

5. 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); 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.

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Procedure: Trigeminal Nerve Stimulation

Primary Outcome(s)

Change in Hamilton Depression Rating Scale 17 score [Time Frame: baseline, week 6, week 12]

Secondary Outcome(s)

Changes in vital signs recordings [Time Frame: At every visit for 12 weeks]

Change in life functional capacity and quality of life scales [Time Frame: baseline, week 6, week 12]

Changes in Regional Brain Function [Time Frame: baseline, week 6, week 12]

Changes in Safety Assessment Measures [Time Frame: At every visit for 12 weeks]

Secondary ID(s)

10-000480

Source(s) of Monetary Support

Please refer to primary and secondary sponsors