Magnetic Seizure Therapy (MST) for Severe Mood Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Magnetic Seizure Therapy (MST) for the Treatment of Severe Mood Disorder

Conditions
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Depression

Intervention / Treatment
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* Device: Thymatron
* Device: Magstim Theta


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-90 Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder Use of effective method of birth control for women of child-bearing capacity Willing and capable to provide informed consent Convulsive therapy clinically indicated Hamilton Rating Scale for Depression (HRSD24) ≥ 20 Exclusion Criteria: Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure) Pregnancy History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion Presence of devices that may be affected by MST (pacemaker, medication pump, cochlear implant, implanted brain stimulator) Breast-feeding History of head trauma with loss of consciousness for greater than 5 minutes History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder Vagus nerve stimulator implanted History of substance abuse or dependence in past 3 months Failure to respond to an adequate course of ECT in the current depressive episode History of ECT in the past 6 months and/or failure to respond to an adequate trial of ECT lifetime Presence of intracardiac lines

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MST<br>Magnetic Seizure Therapy (MST) | Device: Magstim Theta<br>* 100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)<br>* Other names: Magstim Theta, Magnetic Seizure Therapy (MST);|
| Active Comparator: ECT<br>Electroconvulsive Therapy (ECT) | Device: Thymatron<br>* Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)<br>* Other names: Thymatron, Electroconvulsive Therapy (ECT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement (Hamilton Rating Scale for Depression) |  | After each treatment and at follow-ups up to 6 months after the treatment course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated) |  | Before and after treatment course, and at follow-ups up to 6 months after the treatment course | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MST, Magnetic Seizure Therapy, ECT, Electroconvulsive Therapy, Depression, Magnetic