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

Sarah Lisanby

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder

Treatments: Device: Magstim Theta; Device: Thymatron System IV

Study type: Interventional

Funder types: Other

Identifiers

NCT00973934

01-069

4371

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

Magnetic Seizure therapy (MST)

Experimental group

Description:

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

Treatment:

Device: Magstim Theta

Right Unilateral Electroconvulsive Therapy

Active Comparator group

Treatment:

Device: Thymatron System IV