Evaluating the Efficacy of Magnetic Seizure Therapy in Treatment Resistant Depression.

November 16, 2017 updated by: Z. J. Daskalakis, Centre for Addiction and Mental Health
Electroconvulsive therapy (ECT) has unparalleled efficacy in treating severe depression that is resistant to common modalities of treatment, such as antidepressant medication. Although treatment with ECT has benefited many individuals with treatment resistant depression (rates as high as 50-75%), its more widespread use is hindered by the social stigma associated with the treatment, as well as by its significant cognitive side effects. Moreover, ECT cannot be precisely targeted, since it produces a widespread activation of the brain surface, in turn, affecting many different functional areas. Magnetic seizure therapy (MST) is currently being investigated as an alternative to ECT, as it is more focused to one area of the brain. Rather than applying electrical stimuli to induce a seizure, as is done in ECT, MST uses repetitive magnetic stimulation to produce the seizure. Preliminary research suggests that MST can result in therapeutic effects comparable to those produced by ECT, but without the negative side effects on cognition. The proposed study is a randomized, controlled trial, in which the efficacy and side effect profile of MST will be compared to those of ECT. If successful, the results of this study may lead to increased treatment availability and accessibility, as well as lessen the substantial health care costs associated with treatment resistant depression.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6J 1H4
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • inpatients or outpatients
  • voluntary and competent to consent to treatment
  • DSM-IV diagnosis of major depressive disorder, single or recurrent, without psychotic features
  • have failed to achieve a clinical response to adequate treatment trials of at least two antidepressants (with adequacy established according to a predefined criterion on the Antidepressant Treatment History Form (ATHF)) or have been unable to tolerate at least two antidepressants
  • have a baseline HRSD-24 score ≥ 21
  • are considered to be appropriate to receive ECT as assessed by an ECT attending psychiatrist and an anaesthesiologist
  • are agreeable to keeping their current antidepressant treatment constant through the duration of the study
  • are able to adhere to the intervention schedule
  • meet the MST safety criteria
  • are on a medically acceptable form of birth control if a woman of child-bearing potential
  • are a resident of Canada

Exclusion Criteria:

  • have a history of DSM-IV substance dependence or abuse within the past three months
  • have a concomitant major unstable medical illness
  • are acutely suicidal with imminent intent
  • are pregnant or intend to get pregnant during the study
  • have a DSM-IV confirmed diagnosis of bipolar disorder, any psychotic disorder, obsessive compulsive disorder, or post-traumatic stress disorder (current or within the last year)
  • have a DSM-IV diagnosis of borderline personality disorder as assessed by a study investigator
  • have possible or probable dementia
  • have failed a course of ECT within the current depressive episode
  • have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or cognitive impairment (e.g., a space occupying brain lesion, a history of stroke, a cerebral aneurysm, a seizure disorder, Parkinson's disease, Huntington's chorea, multiple sclerosis, head trauma with loss of consciousness for greater than or equal to five minutes)
  • present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease)
  • have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
  • require a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT
  • have an inability to communicate in English fluently enough to complete the neuropsychological tests
  • have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic seizure therapy
Device: Magnetic seizure therapy
100% machine output at 100 Hz, with coil directed over frontal brain regions, until adequate seizure achieved. Treatments will be administered 3 times per week, up to a maximum of 15 treatments. If subjects fail to achieve the pre-defined criteria of remission at that point, they will be considered non-remitters and will exit the study.
Other Names:
  • MagPro MST (Tonica Elektronik A/S, Denmark)
Active Comparator: Electroconvulsive therapy
Device: Electroconvulsive therapy
ECT treatments will be administered 3 times per week using the MECTA spECTrum 5000Q. Subjects will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 6 times the seizure threshold, up to a maximum of 15 treatments. If subjects fail to achieve the pre-defined criteria of remission at that point, they will be considered non-remitters and will exit the study.
Other Names:
  • MECTA spECTrum 5000Q

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression, 24-item (HRSD-24)
Time Frame: Change from baseline in HRSD-24 score at date of symptom remission or date of the 15th treatment, whichever comes first, assessed up to 6 months.
The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms.
Change from baseline in HRSD-24 score at date of symptom remission or date of the 15th treatment, whichever comes first, assessed up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Addiction and Mental Health

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Z. Jeffrey Daskalakis, MD, PhD., Centre for Addiction and Mental Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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