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Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT00956514
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : February 6, 2013
Information provided by (Responsible Party):
Ian A. Cook, M.D., University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Device: Transcranial Magnetic Stimulation Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder
Study Start Date : July 2009
Primary Completion Date : September 2011
Study Completion Date : October 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in HAM-D17 scale score [ Time Frame: baseline, week one, end of week 6 ]
  2. Change in MADRS scale score [ Time Frame: Baseline, week 1, end of week 6 ]
  3. Change in IDS-SR30 scale score [ Time Frame: baseline, week one, end of week 6 ]

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956514

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

Additional Information:
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 ( Other Identifier: UCLA Medical IRB )
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013

Keywords provided by Ian A. Cook, M.D., University of California, Los Angeles:
major depressive disorder
transcranial magnetic stimulation
Major Depression,

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