Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00956514
• Date of registration: 07/08/2009
• Prospective Registration: No
• Primary sponsor: University of California, Los Angeles
• Public title: Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder
• Scientific title: Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder
• Date of first enrolment: July 2009
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00956514
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Ian A Cook, MD
• Affiliation: UCLA Depression Research and Clinic Program

Key inclusion & exclusion criteria

Inclusion Criteria:

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

2. A score of = 20 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
and not more than 2 trials, in the current episode, assessed by the ATHF

4. Age range: 18-64.

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); current MMSE
= 24; delirium or substance abuse 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 within the past 6 months, previous TMS treatment for
any condition, or VNS treatment (lifetime).

4. Patients who have met diagnostic criteria for any current substance abuse disorder
at any time in the 6 months prior to enrollment.

5. 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.

6. Any history of intracranial implant; implanted cardiac pacemaker, defibrillator,
vagus nerve stimulator, deep brain stimulator; or other implanted devices or objects
contraindicated by product labeling.

7. current pregnancy, breast feeding, or not using a medically accepted means of
contraception.

8. Other medical contraindications to any of the study procedures



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Depression

Intervention(s)

Device: Transcranial Magnetic Stimulation

Primary Outcome(s)

Change in HAM-D17 scale score [Time Frame: baseline, week one, end of week 6]

Change in IDS-SR30 scale score [Time Frame: baseline, week one, end of week 6]

Change in MADRS scale score [Time Frame: Baseline, week 1, end of week 6]

Secondary ID(s)

IRB# 09-02-045

09-02-045

Source(s) of Monetary Support

Please refer to primary and secondary sponsors