Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults
Condition: Depression; Major Depressive Episode; Bipolar Disorder
MeSH terms: Seizures; Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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:

        1. MST and ECT will have similar antidepressant efficacy

        2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures of
           anterograde and retrograde amnesia following the acute treatment phase.

        3. At follow up, MST will show a lesser degree of persisting deficit in measures of
           retrograde amnesia than ECT.
    

Detailed description: 
      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.
    

Intervention name(s): MagVenture MagPro MST; RUL ECT
Intervention type(s): Device; Biological
Intervention description(s): Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.; RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Other intervention name(s): Right Unilateral Electroconvulsive Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Electroconvulsive Therapy / Magnetic Seizure Therapy
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Brain Stimulation; Seizure therapy; Convulsive Therapy