Major Depressive Disorder Clinical Trial
— MST-2Official title:
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Verified date | June 2014 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | December 2009 |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Duke Universtiy Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Sarah Lisanby | Stanley Medical Research Institute, University of Texas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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. | Yes |
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