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Magnetic Seizure Therapy (MST) for the Treatment of Major Depression (MST-2)

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Magstim Theta
Thymatron System IV
Sponsored by
Sarah Lisanby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
  • Age 18-75
  • Use of effective method of birth control for women of child-bearing capacity
  • Willing and capable of providing informed consent
  • Convulsive therapy clinically indicated
  • Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item)

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, or structural brain lesion
  • Presence of devices that may be affected by rTMS (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

Sites / Locations

  • Duke Universtiy Medical Center
  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnetic Seizure therapy (MST)

Right Unilateral Electroconvulsive Therapy

Arm Description

Eligible patients will be randomized to receive either a course of thrice weekly MST using either a focal or non focal stimulating coil.

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression (HRSD), 24 item

Secondary Outcome Measures

Beck Depression Inventory
Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments

Full Information

First Posted
September 4, 2009
Last Updated
June 9, 2014
Sponsor
Sarah Lisanby
Collaborators
University of Texas, Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00973934
Brief Title
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Acronym
MST-2
Official Title
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sarah Lisanby
Collaborators
University of Texas, Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Seizure therapy (MST)
Arm Type
Experimental
Arm Description
Eligible patients will be randomized to receive either a course of thrice weekly MST using either a focal or non focal stimulating coil.
Arm Title
Right Unilateral Electroconvulsive Therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Magstim Theta
Intervention Type
Device
Intervention Name(s)
Thymatron System IV
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HRSD), 24 item
Time Frame
A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
A blinded rater will administer the test at Baseline, every Tuesday and Thursady during the treatment course and at the end of the MST course
Title
Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments
Time Frame
A blinded rater will administer various neurospychologiocal tests at various timepoints (baseline, within 3 days following the MST course and at 2 months following the MST course. Treatment Effect Battery (TEB) will be administered at each MST session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder Age 18-75 Use of effective method of birth control for women of child-bearing capacity Willing and capable of providing informed consent Convulsive therapy clinically indicated Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item) 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, or structural brain lesion Presence of devices that may be affected by rTMS (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
Facility Information:
Facility Name
Duke Universtiy Medical Center
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
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

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Magnetic Seizure Therapy (MST) for the Treatment of Major Depression

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