Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD), Neurology, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 55 - 90 |
| Updated: | 11/16/2017 |
| Start Date: | August 2012 |
| End Date: | July 2017 |
Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy
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.
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.
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 depressive episode in the context of either unipolar or bipolar
depression. ECT is known to be highly effective in treating depression, but it can have some
adverse cognitive side effects. MST is a new form of convulsive therapy that is being
developed as a means of improving the side effect profile of ECT so that more patients may
benefit without suffering significant detrimental effects on cognition.
Both ECT and MST rely on a therapeutic seizure, but they do so in different ways. In ECT, an
electrical stimulator is used to pass electrical current between two electrodes placed on the
surface of person's head, which causes some electricity to go through the brain and cause a
seizure. In MST, a magnetic stimulator is used to create a magnetic field in a targeted area
of the brain, which induces a small electrical field in the neurons that causes a seizure.
Treatments will be administered three times a week.
In addition to the treatment sessions, this study will involve a number of assessments at
different time-points (i.e., baseline prior to treatment, post-treatment, 2 months
post-treatment and 6 months post-treatment) that are used to evaluate the person's
antidepressant response and the physical and cognitive side effects of treatment.
Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in older adults currently
experiencing a major depressive episode in the context of either unipolar or bipolar
depression. ECT is known to be highly effective in treating depression, but it can have some
adverse cognitive side effects. MST is a new form of convulsive therapy that is being
developed as a means of improving the side effect profile of ECT so that more patients may
benefit without suffering significant detrimental effects on cognition.
Both ECT and MST rely on a therapeutic seizure, but they do so in different ways. In ECT, an
electrical stimulator is used to pass electrical current between two electrodes placed on the
surface of person's head, which causes some electricity to go through the brain and cause a
seizure. In MST, a magnetic stimulator is used to create a magnetic field in a targeted area
of the brain, which induces a small electrical field in the neurons that causes a seizure.
Treatments will be administered three times a week.
In addition to the treatment sessions, this study will involve a number of assessments at
different time-points (i.e., baseline prior to treatment, post-treatment, 2 months
post-treatment and 6 months post-treatment) that are used to evaluate the person's
antidepressant response and the physical and cognitive side effects of treatment.
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
We found this trial at
1
site
1051 Riverside Dr
New York, New York 10032
New York, New York 10032
646-774-5000
Principal Investigator: Stefan B Rowny, MD
New York State Psychiatric Institute The New York State Psychiatric Institute (NYSPI), established in 1895,...
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