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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2009-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Magstim Theta

Intervention Type DEVICE

Right Unilateral Electroconvulsive Therapy

Group Type ACTIVE_COMPARATOR

Thymatron System IV

Intervention Type DEVICE

Interventions

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Magstim Theta

Intervention Type DEVICE

Thymatron System IV

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No