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WithdrawnNCT01748708Updated Nov 20, 2017

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

An interventional study of Magnetic seizure therapy and Electroconvulsive therapy in Depressive Disorder, sponsored by Centre for Addiction and Mental Health. Withdrawn at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-20.

Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The protocol has undergone significant changes and the investigator feels that it is reasonable to submit a new protocol for review and approval.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depressive Disorder

Keywords

  • Magnetic seizure therapy
  • Electroconvulsive therapy
  • Treatment resistant depression
  • Treatment resistance
  • Randomized controlled trial
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In context

Seizures

881 studies on the registry are indexed under Seizures; 143 are open to participants now.

Browse Seizures studies →

Lead sponsor

Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Magnetic seizure therapy

    Device: Magnetic seizure therapy

  • Active comparator
    Electroconvulsive therapy

    Device: Electroconvulsive therapy

Interventions

  • DeviceMagnetic 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.

    Also known as: MagPro MST (Tonica Elektronik A/S, Denmark)

  • DeviceElectroconvulsive 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.

    Also known as: MECTA spECTrum 5000Q

06

What researchers measure

Primary outcomes

  1. 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.

    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.

07

Study locations

1 site
  • Centre for Addiction and Mental Health
    Toronto, Ontario M6J 1H4, Canada
08

References and documents

Publications

  • 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. PubMed 34131914 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01748708
Lead sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Z. J. Daskalakis (Chair, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health) — Principal investigator
First posted
Dec 12, 2012
Start date
Dec 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Nov 20, 2017

Study contacts

Z. Jeffrey Daskalakis, MD, PhD.
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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