Magnetic Seizure Therapy (MST) for Severe Mood Disorder

This study has been completed.
Sponsor:
Collaborators:
Duke University
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Information provided by (Responsible Party):
Sarah Lisanby, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT00488748
First received: June 18, 2007
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention Phase
Depression
Device: Thymatron
Device: Magstim Theta
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnetic Seizure Therapy (MST) for the Treatment of Severe Mood Disorder

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Clinical improvement (Hamilton Rating Scale for Depression) [ Time Frame: After each treatment and at follow-ups up to 6 months after the treatment course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: June 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Thymatron, Electroconvulsive Therapy (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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488748

Locations
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Sarah Lisanby
Duke University
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Sarah H. Lisanby, MD Duke University
  More Information

Additional Information:
Publications:
Responsible Party: Sarah Lisanby, Professor and Chair, Department of Psychiatry and Behavioral Sciences, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT00488748     History of Changes
Other Study ID Numbers: Pro00026868, Stanley Grant #05T656
Study First Received: June 18, 2007
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Duke University:
MST
Magnetic Seizure Therapy
ECT
Electroconvulsive Therapy
Depression
Magnetic

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mood Disorders
Seizures
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Epilepsy
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014