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NCT Number: NCT05054699

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Institute of Psychiatry, HC-FMUSP

São Paulo, Brazil

About this study

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 and safety profile 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Seizure Therapy

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

Other names: MST

Electroconvulsive therapy

Device

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

Other names: ECT

Primary outcomes

  1. Depressive symptoms

    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.

    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.

  2. Biographical memory

    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.

    Score on the Autobiographical Memory Inventory (AMI). Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity.

Secondary outcomes

  1. Depressive Symptoms

    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.

    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.

  2. Depressive Symptoms

    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.

    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.

  3. Suicidal Thoughts

    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.

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Electroconvulsive Therapy Versus Magnetic Seizure Therapy: Clinical and Cognitive Outcomes

Acronym: EMCODE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2021
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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