Magnetic Seizure Therapy (MST) for Severe Mood Disorder

January 16, 2015 updated by: Sarah Lisanby

Magnetic Seizure Therapy (MST) for the Treatment of Severe Mood Disorder

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:

  1. MST and ECT will have similar antidepressant efficacy.
  2. MST will have less post-treatment amnesia than ECT as reflected in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-90
  • Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
  • Use of effective method of birth control for women of child-bearing capacity
  • Willing and capable to provide informed consent
  • Convulsive therapy clinically indicated
  • Hamilton Rating Scale for Depression (HRSD24) ≥ 20

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, history of known structural brain lesion
  • Presence of devices that may be affected by MST (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 and/or failure to respond to an adequate trial of ECT lifetime
  • Presence of intracardiac lines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MST
Magnetic Seizure Therapy (MST)
Device: Magstim Theta
100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)
Other Names:
  • Magstim Theta, Magnetic Seizure Therapy (MST)
Active Comparator: ECT
Electroconvulsive Therapy (ECT)
Device: Thymatron
Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)
Other Names:
  • Thymatron, Electroconvulsive Therapy (ECT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical improvement (Hamilton Rating Scale for Depression)
Time Frame: After each treatment and at follow-ups up to 6 months after the treatment course
After each treatment and at follow-ups up to 6 months after the treatment course

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated)
Time Frame: Before and after treatment course, and at follow-ups up to 6 months after the treatment course
Before and after treatment course, and at follow-ups up to 6 months after the treatment course

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarah Lisanby

Collaborators

Duke University
University of Texas Southwestern Medical Center
Stanley Medical Research Institute

Investigators

  • Principal Investigator: Sarah H. Lisanby, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Estimate)

January 28, 2015

Last Update Submitted That Met QC Criteria

January 16, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00026868
  • Stanley Grant #05T656

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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