A Phase 3 interventional study of Thymatron and Magstim Theta in Depression, sponsored by Sarah Lisanby. Completed at 2 sites in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-01-28.
Sponsored by Sarah Lisanby · Phase 3, Interventional, and Treatment
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:
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.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 75 is above the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →Sarah Lisanby is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Magnetic Seizure Therapy (MST)
Device: Magstim Theta
Electroconvulsive Therapy (ECT)
Device: Thymatron
Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)
Also known as: Thymatron, Electroconvulsive Therapy (ECT)
100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)
Also known as: Magstim Theta, Magnetic Seizure Therapy (MST)
Clinical improvement (Hamilton Rating Scale for Depression)
Time frame: After each treatment and at follow-ups up to 6 months after the treatment course
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
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Sarah Lisanby