Magnetic Seizure Therapy (MST) for the Treatment of Major Depression

Study Overview
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Brief Summary
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This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).

Official Title
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Magnetic Seizure Therapy (MST) for the Treatment of Major Depression

Conditions
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Major Depressive Disorder

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder Age 18-75 Use of effective method of birth control for women of child-bearing capacity Willing and capable of providing informed consent Convulsive therapy clinically indicated Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item) 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, or structural brain lesion Presence of devices that may be affected by rTMS (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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Seizure therapy (MST)<br>Eligible patients will be randomized to receive either a course of thrice weekly MST using either a focal or non focal stimulating coil. | Device: Magstim Theta<br> <br> |
| Active Comparator: Right Unilateral Electroconvulsive Therapy<br> | Device: Thymatron System IV<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HRSD), 24 item |  | A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory |  | A blinded rater will administer the test at Baseline, every Tuesday and Thursady during the treatment course and at the end of the MST course | 
| Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments |  | A blinded rater will administer various neurospychologiocal tests at various timepoints (baseline, within 3 days following the MST course and at 2 months following the MST course. Treatment Effect Battery (TEB) will be administered at each MST session. |