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

This study is not yet open for participant recruitment.
Verified December 2013 by Centre for Addiction and Mental Health
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Z. J. Daskalakis, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01748708
First received: December 11, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Depressive Disorder
Device: Magnetic seizure therapy
Device: Electroconvulsive therapy

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

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms.


Estimated Enrollment: 200
Study Start Date: September 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: MECTA spECTrum 5000Q

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748708

Contacts
Contact: Jennifer Bennie, MEd 416-535-8501 ext 30148 jennifer.bennie@camh.ca
Contact: Jeff Daskalakis, MD, PhD. 416-535-8501 ext 34319 jeff.daskalakis@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Not yet recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Jennifer Bennie, MEd    416-535-8501 ext 30148    jennifer.bennie@camh.ca   
Contact: Jeff Daskalakis, MD, PhD.    416-535-8501 ext 34319    jeff.daskalakis@camh.ca   
Principal Investigator: Z. Jeffrey Daskalakis, MD, PhD.         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Z. Jeffrey Daskalakis, MD, PhD. Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Z. J. Daskalakis, Chair, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01748708     History of Changes
Other Study ID Numbers: 080-2012
Study First Received: December 11, 2012
Last Updated: December 19, 2013
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
Magnetic seizure therapy
Electroconvulsive therapy
Treatment resistant depression
Treatment resistance
Randomized controlled trial

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

ClinicalTrials.gov processed this record on April 23, 2014