This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.
Magnetic seizure therapy (MST) is a novel, experimental therapeutic intervention, which combines therapeutic aspects of electroconvulsive therapy (ECT) and transcranial magnetic stimulation, in order to achieve the efficacy of the former with the safety of the latter. While ECT remains the most efficacious treatment available for severe and treatment-resistant depression, it is hampered by its side effect profile, specially cognitive deficits, which albeit transitory might be particularly distressing for patient, not to mention the stigma that still clings to this method. MST employs high frequency magnetic pulses applied to the head to the patient in order to induce generalized epileptic activity, thus emulating the core feature of ECT. Though distributed over a large area, such pulses do not penetrate deeper areas of the brain, therefore sparing deeper areas such as the hippocampi, which are crucial for memory encoding. The goal of this study is to compare the antidepressant action of MST to ECT, using a non-inferiority approach. It also aims to compare the cognitive side effects profile of both interventions, as well as investigate possible neuroimaging changes and response predictors before and after treatments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Subjects will receive a train of magnetic pulses (between 600 and 1400 pulses) at 100Hz under general anaesthesia using a Magventure device with a Twin Coil
Subjects will receive a brief-pulse electrical stimulus (between 25 and 1008mC) under general anaesthesia using a ECT device
Institute of Psychiatry, HC-FMUSP
São Paulo, São Paulo, Brazil
RECRUITINGDepressive symptoms
Score on the 17 items Hamilton Depression Rating Scale (HDRS-17). It measures the severity of clinical symptoms, ranging from 0 to 52, with higher scores indicating greater severity.
Time frame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Biographical memory
Score on the Autobiographical Memory Inventory (AMI). Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.
Time frame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Depressive Symptoms
Score on the Montgomery-Asberg Depression Rating Scale (MADRS). It measures the severity of clinical symptoms, ranging from 0 to 60, with higher scores indicating greater severity.
Time frame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Depressive Symptoms
Score on the Beck Depression Inventory (BDI). It measures the severity of clinical symptoms, ranging from 0 to 63, with higher scores indicating greater severity.
Time frame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Suicidal Thoughts
Score on the Beck Scale for Suicidal Ideation (BSS). The BSS contains 19 items that measure the severity of actual suicidal wishes and plans. Scores range from 0 to 38, a higher score indicating a higher level of suicide ideation.
Time frame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
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