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| ID | Type | Description | Link |
|---|---|---|---|
| Stanley Grant #05T656 |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| Stanley Medical Research Institute | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MST | Experimental | Magnetic Seizure Therapy (MST) |
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| ECT | Active Comparator | Electroconvulsive Therapy (ECT) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymatron | Device | Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks) |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah H. Lisanby, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27710 | United States | ||
| University of Texas Southwestern Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12865903 | Background | Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229. | |
| 12942146 | Background | Kosel M, Frick C, Lisanby SH, Fisch HU, Schlaepfer TE. Magnetic seizure therapy improves mood in refractory major depression. Neuropsychopharmacology. 2003 Nov;28(11):2045-8. doi: 10.1038/sj.npp.1300293. |
| Label | URL |
|---|---|
| National Institute of Mental Health - Depression | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Magstim Theta | Device | 100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks) |
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| Dallas |
| Texas |
| 75390 |
| United States |
| 38055283 | Derived | Deng ZD, Luber B, McClintock SM, Weiner RD, Husain MM, Lisanby SH. Clinical Outcomes of Magnetic Seizure Therapy vs Electroconvulsive Therapy for Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Mar 1;81(3):240-249. doi: 10.1001/jamapsychiatry.2023.4599. |
| 34131914 | Derived | Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2. |
| Summary of MST study on Duke Health website | View source |