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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by New York State Psychiatric Institute
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01869374
First received: May 22, 2013
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention Phase
Depression
Major Depressive Episode
Bipolar Disorder
Device: MagVenture MagPro MST
Device: RUL ECT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Clinical improvement (Hamilton Rating Scale for Depression) [ Time Frame: continuos outcome measuring until maximal benefit achieved (avg. 8-12 treatments; 4 weeks average) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated) [ Time Frame: continous outcome measuring until maximal benefit achieved (avg. 8-12 treatments; 4 weeks average) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic Seizure Therapy (MST)
MagVenture MagPro MST device
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.
Active Comparator: RUL ECT
Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus
Device: RUL ECT
RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Other Name: Right Unilateral Electroconvulsive Therapy

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 that are used to evaluate the person's antidepressant response and the physical and cognitive side effects of treatment.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869374

Contacts
Contact: Stefan B Rowny, MD (646) 774-5417 srowny@gmail.com
Contact: Ewa Ciekielska, MA (646) 774-5414 ewaciekielska@gmail.com

Locations
United States, New York
New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Principal Investigator: Stefan B Rowny, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Stefan B Rowny, MD, MFA NYSPI/Columbia University
  More Information

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01869374     History of Changes
Other Study ID Numbers: 6427
Study First Received: May 22, 2013
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Depression
Brain Stimulation
Seizure therapy
Convulsive Therapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Seizures
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014