Major Depressive Disorder
Conditions
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).
Interventions
DEVICEMagstim Theta
DEVICEThymatron System IV
Sponsors
University of Texas
Stanley Medical Research Institute
Sarah Lisanby
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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. |
Countries
United States
Outcome results
None listed