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To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MST or ECT.
The investigators hypothesize:
The purpose of this study is to compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in older adults 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 rely on a therapeutic seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass electrical current between two electrodes placed on the surface of person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to create a magnetic field in a targeted area of the brain, which induces a small electrical field in the neurons that causes a seizure. Treatments will be administered three times a week.
In addition to the treatment sessions, this study will involve a number of assessments at different time-points (i.e., baseline prior to treatment, post-treatment, 2 months post-treatment and 6 months post-treatment) 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 |
|---|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | MagVenture MagPro MST device |
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| RUL ECT | Active Comparator | Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagVenture MagPro MST | Device | Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression, 24-Item (HRSD-24) | The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder. The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome: 0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study. | baseline (pre-treatment) and post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan B Rowny, MD, MFA | NYSPI/Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Rowny, S., & Lisanby, S. H. (2009). Other Brain Stimulation Methods. In B. J. Sadock, V.A. Sadock & P. Ruiz (Eds.) . Kaplan and Sadock's Comprehensive Textbook of Psychiatry (9th ed.) (Pp. 3301-3314). Lippincott Williams & Wilkins. Philadelphia:PA. | ||
| 19348798 | Background | Rowny SB, Benzl K, Lisanby SH. Translational development strategy for magnetic seizure therapy. Exp Neurol. 2009 Sep;219(1):27-35. doi: 10.1016/j.expneurol.2009.03.029. Epub 2009 Apr 5. | |
| 22217479 |
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Five-day washout from all anti-depressants and mood stabilizers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnetic Seizure Therapy (MST) | MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week. |
| FG001 | RUL ECT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2016 | Feb 27, 2020 |
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Electroconvulsive Therapy / Magnetic Seizure Therapy
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| RUL ECT | Biological | RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week. |
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| Background |
| McClintock SM, DeWind NK, Husain MM, Rowny SB, Spellman TJ, Terrace H, Lisanby SH. Disruption of component processes of spatial working memory by electroconvulsive shock but not magnetic seizure therapy. Int J Neuropsychopharmacol. 2013 Feb;16(1):177-87. doi: 10.1017/S1461145711001866. Epub 2012 Jan 5. |
| 19497373 | Background | Rowny SB, Cycowicz YM, McClintock SM, Truesdale MD, Luber B, Lisanby SH. Differential heart rate response to magnetic seizure therapy (MST) relative to electroconvulsive therapy: a nonhuman primate model. Neuroimage. 2009 Sep;47(3):1086-91. doi: 10.1016/j.neuroimage.2009.05.070. Epub 2009 Jun 2. |
| Background | Rowny, S., & Lisanby, S. H. (2008). Brain Stimulation in Psychiatry. In A. Tasman, J. Kay, J. A. Lieberman, M. B. First & M. Maj (Eds.), Psychiatry (3rd ed.) (pp.2354-2371). Chichester, UK: John Wiley & Sons. DOI: 10.1002/9780470515167.ch109 |
| 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. |
Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnetic Seizure Therapy (MST) | MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week. |
| BG001 | Right Unilateral ECT (RUL ECT) | Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression, 24-Item (HRSD-24) | The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder. The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome: 0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study. | Posted | Mean | Full Range | units on a scale | baseline (pre-treatment) and post-treatment |
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Adverse event data for participants was collected from baseline to post-treatment (between two and three months, depending on the participants' number of treatments).
This study did not include a design for monitoring or assessing adverse events. We did not consider any of our participants to be at risk of serious adverse events or all-cause mortality. Prior to enrollment in the study, all our participants were evaluated by a physician and anesthesiologist and were medically cleared to receive an acute course of convulsive therapy. Any risk that would have been contraindicated with convulsive therapy was ruled out in advance of participants' pre-tx scan.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnetic Seizure Therapy (MST) | MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | RUL ECT | Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week. | 0 | 18 | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stefan Rowny, MD | New York State Psychiatric Institute | (646) 774-5417 | stefan.rowny@nyspi.columbia.edu |
| ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 11, 2017 | Feb 27, 2020 | Prot_001.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Between 18 and 65 years |
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| >=65 years |
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