Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2025-06-01

Brief Summary

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This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.

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Detailed Description

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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.

Conditions

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Major Depressive Disorder Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomly and blindly allocated to either of two interventions, namely, MST or ECT. Clinical and cognitive parameters will be assessedat baseline, weeks 6, 12 and 18.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Patients will be anaesthetised before the procedure, therefore will not be able to tell whether they received ECT ou MST. The preparation procedures before seizure will be identical for all participants regardless of the intervention. All monitoring and other procedures will be exactly the same for both groups. Investigator and rater will not have access to which procedure subjects received. To blind the staff, the MST sound will performed during all study interventions.

Study Groups

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MST

Subjects will receive 12-18 sessions of frontal Magnetic Seizure Therapy under general anaesthesia, twice a week. Clinical and cognitive measures will be assessed before, during and after the treatment

Group Type EXPERIMENTAL

Magnetic Seizure Therapy

Intervention Type DEVICE

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

ECT

Subjects will receive 12-18 sessions of bilateral Electroconvulsive Therapy under general anaesthesia, twice a week. Clinical and cognitive measures will be assessed before, during and after the treatment

Group Type ACTIVE_COMPARATOR

Electroconvulsive Therapy

Intervention Type DEVICE

Subjects will receive a brief-pulse electrical stimulus (between 25 and 1008mC) under general anaesthesia using a ECT device

Interventions

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Magnetic Seizure Therapy

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

Intervention Type DEVICE

Electroconvulsive Therapy

Subjects will receive a brief-pulse electrical stimulus (between 25 and 1008mC) under general anaesthesia using a ECT device

Intervention Type DEVICE

Other Intervention Names

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MST ECT

Eligibility Criteria

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Inclusion Criteria

* Major Depressive Disorder or Bipolar Depression in accordance to the Diagnostic and Statistical Manual (DSM) criteria
* Score equal to or great than 17 points on the Hamilton Depression Rating Scale
* Treatment-resistant depression, defined as insufficient relief of symptoms after two different first line treatments using therapeutic doses and for four to six weeks
* Adequate health and clinical conditions, as assessed by an anaesthesiologist and a psychiatrist

Exclusion Criteria

* Pregnancy
* Other psychiatric conditions such as Schizophrenia, Schizoaffective Disorder, Substance Abuse, Borderline Personality Disorder, PTSD, or Intellectual Deficiency
* Depressive symptoms due to a clinical condition
* Any clinical or neurological conditions without proper management
* ECT or any other neuromodulation treatment on the last six months
* Inability to consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No