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

Phase 2

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: Magstim Theta; Device: Thymatron System IV

• Registration Number: NCT00973934
• Lead Sponsor: Sarah Lisanby

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2006-01
• Study First Submitted: 2009-09-04
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Study Completion: 2009-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-09
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic Seizure therapy (MST)	Magstim Theta	Eligible patients will be randomized to receive either a course of thrice weekly MST using either a focal or non focal stimulating coil.
Right Unilateral Electroconvulsive Therapy	Thymatron System IV	-

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression (HRSD), 24 item	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

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

Trial Locations

Locations (2)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Duke Universtiy Medical Center; 🇺🇸 Durham, North Carolina, United States