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Depression | Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults

Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depression

Major Depressive Episode

Bipolar Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:MagVenture MagPro MSTBrain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.

Biological:RUL ECTRUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Magnetic Seizure Therapy (MST)MagVenture MagPro MST device

RUL ECTRight Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus

Study Status

Completed

Start Date: August 2012

Completed Date: July 2017

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Clinical improvement (Hamilton Rating Scale for Depression)

Secondary Outcome: Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated)

Study sponsors, principal investigator, and references

Principal Investigator: Stefan B Rowny, MD, MFA

Lead Sponsor: New York State Psychiatric Institute

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01869374

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