Bipolar Disorder, Depression, Major Depressive Episode
Conditions
Keywords
Depression, Brain Stimulation, Seizure therapy, Convulsive Therapy
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 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.
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 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.
Interventions
DEVICEMagVenture MagPro MST
Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.
BIOLOGICALRUL ECT
RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Electroconvulsive Therapy / Magnetic Seizure Therapy
Eligibility
Sex/Gender
ALL
Age
55 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Rating Scale for Depression, 24-Item (HRSD-24) | baseline (pre-treatment) and post-treatment | The unabbreviated scale title is Hamilton Rating Scale for Depression. As its title suggests, this is a clinical measure of major depressive disorder. The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome: 0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study. |
Countries
United States
Participant flow
Pre-assignment details
Five-day washout from all anti-depressants and mood stabilizers.
Participants by arm
| Arm | Count |
|---|---|
| Magnetic Seizure Therapy (MST) MagVenture MagPro MST device
MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week. | 9 |
| Right Unilateral ECT (RUL ECT) Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus
RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Right Unilateral ECT (RUL ECT) | Total | Magnetic Seizure Therapy (MST) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 9 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 9 Participants | 5 Participants |
| Age, Continuous | 65.3 years | 65.8 years | 66.3 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 9 participants | 18 participants | 9 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Hamilton Rating Scale for Depression, 24-Item (HRSD-24)
The unabbreviated scale title is Hamilton Rating Scale for Depression. As its title suggests, this is a clinical measure of major depressive disorder. The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome: 0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study.
Time frame: baseline (pre-treatment) and post-treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Hamilton Rating Scale for Depression, 24-Item (HRSD-24) | 22.625 units on a scale |
| RUL ECT | Hamilton Rating Scale for Depression, 24-Item (HRSD-24) | 15.375 units on a scale |