Magnetic Seizure Therapy (MST) for Severe Mood Disorder - Full Text View

Sponsor:	New York State Psychiatric Institute
Collaborators:	University of Texas Southwestern Medical Center Stanley Medical Research Institute
Information provided by:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00488748

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:

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Magnetic Seizure Therapy (MST) for the Treatment of Severe Mood Disorder

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxine-dependent epilepsy

MedlinePlus related topics: Depression Seizures

U.S. FDA Resources

Further study details as provided by New York State Psychiatric Institute:

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 ]

Estimated Enrollment:	75
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MST: Experimental Magnetic Seizure Therapy (MST)	Device: Magstim Theta 100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)
ECT: Active Comparator Electroconvulsive Therapy (ECT)	Device: Thymatron Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)

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

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

Contacts

Contact: Clinic Coordinator

212-543-5767

depression@columbia.edu

Locations

United States, New York
New York State Psychiatric Institute	Recruiting
New York, New York, United States, 10032
Contact: Clinic Coordinator 212-543-5767 depression@columbia.edu
Principal Investigator: Sarah H. Lisanby, M.D.
United States, Texas
University of Texas Southwestern Medical Center	Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Shawn McClintock, Ph.D. 214-648-2840
Principal Investigator: Mustafa M. Husain, M.D.

Sponsors and Collaborators

New York State Psychiatric Institute

University of Texas Southwestern Medical Center

Stanley Medical Research Institute

Investigators

Principal Investigator:

Sarah H. Lisanby, MD

New York State Psychiatric Institute

More Information

Additional Information:

National Institute of Mental Health - Depression This link exits the ClinicalTrials.gov site

Summary of MST on the Brain Stimulation Division web site This link exits the ClinicalTrials.gov site

Publications:

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.

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.

Responsible Party:	New York State Psychiatric Institute ( Clinic Coordinator )
Study ID Numbers:	5097, Stanley Grant #05T656
Study First Received:	June 18, 2007
Last Updated:	November 14, 2008
ClinicalTrials.gov Identifier:	NCT00488748 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:

MST
Magnetic Seizure Therapy
ECT

Electroconvulsive Therapy
Depression
Magnetic

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 08, 2010