Status:
COMPLETED
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
Lead Sponsor:
Sarah Lisanby
Collaborating Sponsors:
University of Texas
Stanley Medical Research Institute
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00973934
Start Date
April 1 2002
End Date
December 1 2009
Last Update
June 10 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke Universtiy Medical Center
Durham, North Carolina, United States, 27710
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390