Evaluating the Efficacy of Magnetic Seizure Therapy in Treatment Resistant Depression.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- 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: | June 2013 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | September 2017 (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 |
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| Contact: Cinthia Ramos, BSc. | 416-535-8501 ext 33062 | cinthia.ramos@camh.ca |
| Contact: Jeff Daskalakis, MD, PhD. | 416-535-8501 ext 34319 | jeff.daskalakis@camh.ca |
| Canada, Ontario | |
| Centre for Addiction and Mental Health | Not yet recruiting |
| Toronto, Ontario, Canada, M6J 1H4 | |
| Contact: Cinthia Ramos, BSc. 416-535-8501 ext 33062 cinthia.ramos@camh.ca | |
| Contact: Jeff Daskalakis, MD, PhD. 416-535-8501 ext 34319 jeff.daskalakis@camh.ca | |
| Principal Investigator: Z. Jeffrey Daskalakis, MD, PhD. | |
| 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: | April 2, 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 May 23, 2013