Status:
COMPLETED
Neurophysiologic Predictors of Outcome With rTMS Treatment of Major Depressive Disorder
Lead Sponsor:
University of California, Los Angeles
Conditions:
Depression
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
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 pat...
Detailed Description
A critical challenge in the management of major depressive disorder (MDD) is the selection of treatment for each individual patient. Although treatments with depression can restore people's lives, wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00956514
Start Date
July 1 2009
End Date
October 1 2011
Last Update
February 6 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UCLA Depression Research and Clinic Program
Los Angeles, California, United States, 90024-1759