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

University of Sao Paulo

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Major Depressive Disorder; Bipolar Depression

Treatments: Device: Magnetic Seizure Therapy; Device: Electroconvulsive Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05054699

29979220.4.0000.0068

Details and patient eligibility

About

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

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

MST

Experimental group

Description:

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

Treatment:

Device: Magnetic Seizure Therapy

ECT

Active Comparator group

Description:

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

Treatment:

Device: Electroconvulsive Therapy