Magnetic Seizure Therapy (MST) for Severe Mood Disorder
This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. The investigators will conduct a number of clinical and neuropsychological tests to assess clinical and cognitive response to treatment. The investigators hypothesize that:
- MST and ECT will have similar antidepressant efficacy.
- MST will have less post-treatment amnesia than ECT as reflected in primary measures of anterograde and retrograde amnesia following the acute treatment phase.
- At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Magnetic Seizure Therapy (MST) for the Treatment of Severe Mood Disorder|
- Clinical improvement (Hamilton Rating Scale for Depression) [ Time Frame: After each treatment and at follow-ups up to 6 months after the treatment course ] [ Designated as safety issue: No ]
- Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated) [ Time Frame: Before and after treatment course, and at follow-ups up to 6 months after the treatment course ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Magnetic Seizure Therapy (MST)
Device: Magstim Theta
100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)
Other Name: Magstim Theta, Magnetic Seizure Therapy (MST)
Active Comparator: ECT
Electroconvulsive Therapy (ECT)
Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)
Other Name: Thymatron, Electroconvulsive Therapy (ECT)
The purpose of this study is to compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. ECT is known to be highly effective in treating depression, but it can have some adverse cognitive side effects. MST is a new form of convulsive therapy that is being developed as a means of improving the side effect profile of ECT so that more patients may benefit without suffering significant detrimental effects on cognition.
Both ECT and MST cause a seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass an electrical current between two electrodes placed on the person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to pass a magnetic field to the brain, which then creates a small electrical field in the brain that causes a seizure.
In addition to the treatment sessions, this study will involve a number of assessments at different timepoints that are used to evaluate the person's antidepressant response and the physical and cognitive side effects of treatment.
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Sarah H. Lisanby, MD||Duke University|