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

S

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

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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