Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder
This study has been completed.
Information provided by (Responsible Party):
Ian A. Cook, M.D., University of California, Los Angeles
First received: August 7, 2009
Last updated: February 4, 2013
Last verified: February 2013
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.
Device: Transcranial Magnetic Stimulation
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2011 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 64 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Outpatients with non-psychotic, unipolar Major Depressive Disorder (MDD) assessed via the MINI structured interview
- A score of ≥ 20 on the HAM-D17 with Item 1 (depressed mood) ≥ 2
- 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
- Age range: 18-64.
- 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.
- 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); 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.
- Patients with exposure to ECT within the past 6 months, previous TMS treatment for any condition, or VNS treatment (lifetime).
- Patients who have met diagnostic criteria for any current substance abuse disorder at any time in the 6 months prior to enrollment.
- 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.
- 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.
- current pregnancy, breast feeding, or not using a medically accepted means of contraception.
- Other medical contraindications to any of the study procedures
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956514
|UCLA Depression Research and Clinic Program
|Los Angeles, California, United States, 90024-1759 |
University of California, Los Angeles
||Ian A Cook, MD
||UCLA Depression Research and Clinic Program
No publications provided
||Ian A. Cook, M.D., Principal Investigator, University of California, Los Angeles
History of Changes
|Other Study ID Numbers:
||09-02-045, IRB# 09-02-045
|Study First Received:
||August 7, 2009
||February 4, 2013
||United States: Institutional Review Board
Keywords provided by University of California, Los Angeles:
major depressive disorder
transcranial magnetic stimulation
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 17, 2014
Depressive Disorder, Major