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

Primary Purpose

Depressive Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Magnetic seizure therapy
Electroconvulsive therapy
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Magnetic seizure therapy, Electroconvulsive therapy, Treatment resistant depression, Treatment resistance, Randomized controlled trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Magnetic seizure therapy

Electroconvulsive therapy

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression, 24-item (HRSD-24)
The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2012
Last Updated
November 16, 2017
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT01748708
Brief Title
Evaluating the Efficacy of Magnetic Seizure Therapy in Treatment Resistant Depression.
Official Title
Evaluating the Efficacy of Magnetic Seizure Therapy in Treatment Resistant Depression.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
The protocol has undergone significant changes and the investigator feels that it is reasonable to submit a new protocol for review and approval.
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Magnetic seizure therapy, Electroconvulsive therapy, Treatment resistant depression, Treatment resistance, Randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic seizure therapy
Arm Type
Experimental
Arm Title
Electroconvulsive therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Magnetic seizure therapy
Other Intervention Name(s)
MagPro MST (Tonica Elektronik A/S, Denmark)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Electroconvulsive therapy
Other Intervention Name(s)
MECTA spECTrum 5000Q
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression, 24-item (HRSD-24)
Description
The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Z. Jeffrey Daskalakis, MD, PhD.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Citations:
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
Links:
URL
http://www.camh.ca/en/research/Pages/research.aspx
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre

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

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