Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ian A. Cook, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00956514
First received: August 7, 2009
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

Transcranial magnetic stimulation (TMS) therapy has proven to lead to symptom improvement in many individuals with major depressive disorder (MDD), yet there is heterogeneity in outcome, with some patients showing robust remission and other showing minimal symptom change. Identifying which individuals are likely to benefit from TMS therapy early in the course of treatment would support continued treatment for those predicted to do well, and consideration of alternative treatments for others individuals. This study will test specific hypotheses about the relationships between early neurophysiologic changes and later clinical outcome with TMS treatment.


Condition Intervention Phase
Depression
Device: Transcranial Magnetic Stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in HAM-D17 scale score [ Time Frame: baseline, week one, end of week 6 ] [ Designated as safety issue: No ]
  • Change in MADRS scale score [ Time Frame: Baseline, week 1, end of week 6 ] [ Designated as safety issue: No ]
  • Change in IDS-SR30 scale score [ Time Frame: baseline, week one, end of week 6 ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2009
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial Magenetic Stimulation
All subjects will be assigned to active, open-label treatment with the NeuroStar TMS System for 6 weeks (30 treatment sessions).
Device: Transcranial Magnetic Stimulation
Neurophysiologic Predictors of Outcome with rTMS Treatment of Major Depressive Disorder

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956514

Locations
United States, California
UCLA Depression Research and Clinic Program
Los Angeles, California, United States, 90024-1759
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Ian A Cook, MD UCLA Depression Research and Clinic Program
  More Information

Additional Information:
No publications provided

Responsible Party: Ian A. Cook, M.D., Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00956514     History of Changes
Other Study ID Numbers: 09-02-045, IRB# 09-02-045
Study First Received: August 7, 2009
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
depression
major depressive disorder
transcranial magnetic stimulation
TMS
EEG
electroencephalography
Major Depression,

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on October 21, 2014