Magnetic Seizure Therapy (MST) for the Treatment of Major Depression (MST-2)
June 9, 2014 updated by: Sarah Lisanby
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
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
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Universtiy Medical Center
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
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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
14 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Magnetic Seizure therapy (MST)
Eligible patients will be randomized to receive either a course of thrice weekly MST using either a focal or non focal stimulating coil.
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Active Comparator: Right Unilateral Electroconvulsive Therapy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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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 Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
|
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.
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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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
April 1, 2002
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 4, 2009
First Submitted That Met QC Criteria
September 8, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
June 10, 2014
Last Update Submitted That Met QC Criteria
June 9, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4371
- 01-069
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.