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Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults (MSTvsEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01869374
Recruitment Status : Active, not recruiting
First Posted : June 5, 2013
Last Update Posted : June 4, 2019
Information provided by (Responsible Party):
Stefan Rowny, New York State Psychiatric Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Major Depressive Episode Bipolar Disorder Device: MagVenture MagPro MST Biological: RUL ECT Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Electroconvulsive Therapy / Magnetic Seizure Therapy
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy
Study Start Date : August 2012
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: Magnetic Seizure Therapy (MST)
MagVenture MagPro MST device
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.

Active Comparator: RUL ECT
Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus
Biological: RUL ECT
RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Other Name: Right Unilateral Electroconvulsive Therapy

Primary Outcome Measures :
  1. Clinical improvement (Hamilton Rating Scale for Depression) [ Time Frame: continuous outcome measuring until maximal benefit achieved (avg. 8-12 treatments; 4 weeks average) ]

Secondary Outcome Measures :
  1. Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated) [ Time Frame: continuous outcome measuring until maximal benefit achieved (avg. 8-12 treatments; 4 weeks average) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 55-90
  • Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
  • Willing and capable to provide informed consent
  • Convulsive therapy clinically indicated
  • Hamilton Rating Scale for Depression (HRSD24)≥ 20
  • Mini Mental State Exam (MMSE) ≥ 24
  • For outpatients: responsible adult living with the patient

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)
  • 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, or vagus nerve stimulator implanted)
  • History of head trauma with loss of consciousness for greater than 5 minutes
  • History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01869374

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United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
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Principal Investigator: Stefan B Rowny, MD, MFA NYSPI/Columbia University

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Responsible Party: Stefan Rowny, Assistant Professor of Clinical Psychiatry, New York State Psychiatric Institute Identifier: NCT01869374    
Other Study ID Numbers: 6427
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Stefan Rowny, New York State Psychiatric Institute:
Brain Stimulation
Seizure therapy
Convulsive Therapy
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms