Phase 2
N=18
Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults
Depression · Major Depressive Episode · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01869374 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Hamilton Rating Scale for Depression, 24-Item (HRSD-24) — 22.625; 15.375 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MagVenture MagPro MST (Device); RUL ECT (Biological)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Rating Scale for Depression, 24-Item (HRSD-24) |
22.625; 15.375 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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 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)
- 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
Data sourced from ClinicalTrials.gov (NCT01869374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.