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

Primary Purpose

Depression, Major Depressive Episode, Bipolar Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MagVenture MagPro MST
RUL ECT
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Brain Stimulation, Seizure therapy, Convulsive Therapy

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnetic Seizure Therapy (MST)

RUL ECT

Arm Description

MagVenture MagPro MST device

Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2013
Last Updated
August 18, 2020
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01869374
Brief Title
Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults
Acronym
MSTvsEST
Official Title
Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: MST and ECT will have similar antidepressant efficacy 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Major Depressive Episode, Bipolar Disorder
Keywords
Depression, Brain Stimulation, Seizure therapy, Convulsive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Electroconvulsive Therapy / Magnetic Seizure Therapy
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic Seizure Therapy (MST)
Arm Type
Experimental
Arm Description
MagVenture MagPro MST device
Arm Title
RUL ECT
Arm Type
Active Comparator
Arm Description
Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus
Intervention Type
Device
Intervention Name(s)
MagVenture MagPro MST
Intervention Description
Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.
Intervention Type
Biological
Intervention Name(s)
RUL ECT
Other Intervention Name(s)
Right Unilateral Electroconvulsive Therapy
Intervention Description
RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression, 24-Item (HRSD-24)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan B Rowny, MD, MFA
Organizational Affiliation
NYSPI/Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Rowny, S., & Lisanby, S. H. (2009). Other Brain Stimulation Methods. In B. J. Sadock, V.A. Sadock & P. Ruiz (Eds.) . Kaplan and Sadock's Comprehensive Textbook of Psychiatry (9th ed.) (Pp. 3301-3314). Lippincott Williams & Wilkins. Philadelphia:PA.
Results Reference
background
PubMed Identifier
19348798
Citation
Rowny SB, Benzl K, Lisanby SH. Translational development strategy for magnetic seizure therapy. Exp Neurol. 2009 Sep;219(1):27-35. doi: 10.1016/j.expneurol.2009.03.029. Epub 2009 Apr 5.
Results Reference
background
PubMed Identifier
22217479
Citation
McClintock SM, DeWind NK, Husain MM, Rowny SB, Spellman TJ, Terrace H, Lisanby SH. Disruption of component processes of spatial working memory by electroconvulsive shock but not magnetic seizure therapy. Int J Neuropsychopharmacol. 2013 Feb;16(1):177-87. doi: 10.1017/S1461145711001866. Epub 2012 Jan 5.
Results Reference
background
PubMed Identifier
19497373
Citation
Rowny SB, Cycowicz YM, McClintock SM, Truesdale MD, Luber B, Lisanby SH. Differential heart rate response to magnetic seizure therapy (MST) relative to electroconvulsive therapy: a nonhuman primate model. Neuroimage. 2009 Sep;47(3):1086-91. doi: 10.1016/j.neuroimage.2009.05.070. Epub 2009 Jun 2.
Results Reference
background
Citation
Rowny, S., & Lisanby, S. H. (2008). Brain Stimulation in Psychiatry. In A. Tasman, J. Kay, J. A. Lieberman, M. B. First & M. Maj (Eds.), Psychiatry (3rd ed.) (pp.2354-2371). Chichester, UK: John Wiley & Sons. DOI: 10.1002/9780470515167.ch109
Results Reference
background
PubMed Identifier
34131914
Citation
Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.
Results Reference
derived

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

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