Clinical trial NCT00973934: Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Official title: Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Texas
name: Stanley Medical Research Institute
First posted: 2009-09-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression (HRSD), 24 item
timeFrame: 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 outcomes:
measure: Beck Depression Inventory
timeFrame: 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
measure: Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments
timeFrame: 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.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Universtiy Medical Center
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
citation: Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.