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

NCT01869374 | Completed Phase 1 Results

• 1 other identifier: 6427
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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. 1.MST and ECT will have similar antidepressant efficacy
2. 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. 3.At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.

Conditions

Depression; Major Depressive Episode; Bipolar Disorder

Keywords

Depression; Brain Stimulation; Seizure therapy; Convulsive Therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline (pre-treatment) and post-treatment

Study Arms (2)

Magnetic Seizure Therapy (MST)

EXPERIMENTAL

MagVenture MagPro MST device

Device: MagVenture MagPro MST

RUL ECT

ACTIVE COMPARATOR

Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus

Biological: RUL ECT

Interventions

MagVenture MagPro MST DEVICE

Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.

Magnetic Seizure Therapy (MST)

RUL ECT BIOLOGICAL

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

Also known as: Right Unilateral Electroconvulsive Therapy

RUL ECT

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (6)

• 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.

  BACKGROUND

• 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.

  PMID: 19348798 BACKGROUND

• 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.

  PMID: 22217479 BACKGROUND

• 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.

  PMID: 19497373 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 34131914 DERIVED

MeSH Terms

Conditions

Depression; Bipolar Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Stefan Rowny, MD
• Organization: New York State Psychiatric Institute

stefan.rowny@nyspi.columbia.edu

(646) 774-5417

Study Officials

• Stefan B Rowny, MD, MFA

  NYSPI/Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Psychiatry

Model Details: Electroconvulsive Therapy / Magnetic Seizure Therapy

Study Record Dates

• First Submitted: May 22, 2013
• First Posted: June 5, 2013
• Study Start: August 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: August 1, 2020
• Last Updated: September 3, 2020
• Results First Posted: June 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)