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Withdrawn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
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
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
NCT ID
NCT01748708
First Posted
December 11, 2012
Last Updated
November 16, 2017
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)
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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