Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder
This study has been completed.
Sponsor:
University of California, Los Angeles
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
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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 |
Resource links provided by NLM:
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:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
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 Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013