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

Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Magnetic seizure therapy100% 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.

Device:Electroconvulsive therapyECT 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Magnetic seizure therapy

Electroconvulsive therapy

Study Status

Withdrawn

Start Date: December 2016

Completed Date: December 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Hamilton Rating Scale for Depression, 24-item (HRSD-24)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Z. Jeffrey Daskalakis, MD, PhD.

Lead Sponsor: Centre for Addiction and Mental Health

Collaborator: Canadian Institutes of Health Research (CIHR)

More information:https://clinicaltrials.gov/show/NCT01748708

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