Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults
Completed · Phase 1/Phase 2
Conditions studied: Depression, Major Depressive Episode, Bipolar Disorder
In brief
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 MST or ECT. The investigators hypothesize: 1. MST and ECT will have similar antidepressant efficacy 2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures of anterograde and retrograde amnesia following the acute treatment phase. 3. At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.
Key facts
- Study ID
- NCT01869374
- Run by
- New York State Psychiatric Institute
- People needed
- 18
- Starts
- 2012-08-01
- Expected to finish
- 2020-08-01
- Last updated by the study team
- 2020-09-03
Who can join
Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- New York State Psychiatric Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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