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Magnetic Seizure Therapy (MST) for Severe Mood Disorder

Primary Purpose

Depression

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Thymatron

Magstim Theta

About this trial

This is an interventional treatment trial for Depression focused on measuring MST, Magnetic Seizure Therapy, ECT, Electroconvulsive Therapy, Depression, Magnetic

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University
University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MST

ECT

Arm Description

Magnetic Seizure Therapy (MST)

Electroconvulsive Therapy (ECT)

Outcomes

Primary Outcome Measures

Clinical improvement (Hamilton Rating Scale for Depression)

Secondary Outcome Measures

Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated)

Full Information

NCT ID

NCT00488748

First Posted

June 18, 2007

Last Updated

January 16, 2015

Sponsor

Sarah Lisanby

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00488748

Brief Title

Magnetic Seizure Therapy (MST) for Severe Mood Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sarah Lisanby

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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: MST and ECT will have similar antidepressant efficacy. MST will have less post-treatment amnesia than ECT as reflected in primary measures of anterograde and retrograde amnesia following the acute treatment phase. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

MST, Magnetic Seizure Therapy, ECT, Electroconvulsive Therapy, Depression, Magnetic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MST

Arm Type

Experimental

Arm Description

Magnetic Seizure Therapy (MST)

Arm Title

ECT

Arm Type

Active Comparator

Arm Description

Electroconvulsive Therapy (ECT)

Intervention Type

Device

Intervention Name(s)

Thymatron

Other Intervention Name(s)

Thymatron, Electroconvulsive Therapy (ECT)

Intervention Description

Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)

Intervention Type

Device

Intervention Name(s)

Magstim Theta

Other Intervention Name(s)

Magstim Theta, Magnetic Seizure Therapy (MST)

Intervention Description

100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)

Primary Outcome Measure Information:

Title

Clinical improvement (Hamilton Rating Scale for Depression)

Time Frame

After each treatment and at follow-ups up to 6 months after the treatment course

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sarah H. Lisanby, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12865903

Citation

Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229.

Results Reference

background

PubMed Identifier

12942146

Citation

Kosel M, Frick C, Lisanby SH, Fisch HU, Schlaepfer TE. Magnetic seizure therapy improves mood in refractory major depression. Neuropsychopharmacology. 2003 Nov;28(11):2045-8. doi: 10.1038/sj.npp.1300293.

Results Reference

background

PubMed Identifier

34131914

Citation

Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.

Results Reference

derived

Links:

URL

http://www.nimh.nih.gov/publicat/depression.cfm

Description

National Institute of Mental Health - Depression

URL

http://www.dukehealth.org/clinicaltrials/magnetic-seizure-therapy-mst-for-the-treatment-of-severe-mood-disorder

Description

Summary of MST study on Duke Health website

Learn more about this trial

Magnetic Seizure Therapy (MST) for Severe Mood Disorder

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