Status:
COMPLETED
Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Depression
Major Depressive Episode
Eligibility:
All Genders
55-90 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MS...
Detailed Description
The purpose of this study is to compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in older adults currently experiencing a major depr...
Eligibility Criteria
Inclusion
- Age 55-90
- Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- Willing and capable to provide informed consent
- Convulsive therapy clinically indicated
- Hamilton Rating Scale for Depression (HRSD24)≥ 20
- Mini Mental State Exam (MMSE) ≥ 24
- For outpatients: responsible adult living with the patient
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)
- History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion
- Presence of devices that may be affected by MST (pacemaker, medication pump, cochlear implant, implanted brain stimulator, or vagus nerve stimulator implanted)
- History of head trauma with loss of consciousness for greater than 5 minutes
- History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
- 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 and/or failure to respond to an adequate trial of ECT lifetime
- Presence of intracardiac lines
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01869374
Start Date
August 1 2012
End Date
August 1 2020
Last Update
September 3 2020
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032