Major Depressive DisorderPhase 2/3EMCODENCT05054699
Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study
A Phase 2/3 study testing Magnetic Seizure Therapy and Electroconvulsive Therapy in people with Major Depressive Disorder and Bipolar Depression, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Depression
- What is being tested?
- Magnetic Seizure Therapy and Electroconvulsive Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 31 May 2021to 30 Jun 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Electroconvulsive Therapy Versus Magnetic Seizure Therapy: Clinical and Cognitive Outcomes
This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.
Read the detailed 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 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.
- Conditions
- Major Depressive Disorder, Bipolar Depression
- Being tested
- Magnetic Seizure Therapy, Electroconvulsive Therapy
- Keywords
- Magnetic Seizure Therapy, Electroconvulsive Therapy, Depression, Major Depressive Disorder, Bipolar Depression, Cognition
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Seizure TherapyDevice
Also called MST
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
Electroconvulsive TherapyDevice
Also called ECT
Subjects will receive a brief-pulse electrical stimulus (between 25 and 1008mC) under general anaesthesia using a ECT device
| Study group | Role | What they receive |
|---|---|---|
| MST | Experimental | 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 Receives: Device: Magnetic Seizure Therapy |
| ECT | Active comparator | 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 Receives: Device: Electroconvulsive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive 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.
Measured: 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.
Measured: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start31 May 2021
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Andre R Brunoni, University of Sao Paulo
- Investigators
- ANDRE R BRUNONI, Principal investigator, FACULDADE DE MEDICINA DA USP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054699
- Sponsor's protocol ID
- 29979220.4.0000.0068
- Acronym
- EMCODE
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2021
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cretaz E, Bellini H, Gallucci-Neto J, Carneiro AM, Dos Santos LA, Miranda CS, Brunoni AR. Use of Magnetic Seizure Therapy for Treatment-Resistant Depression: A Case Series. J ECT. 2022 Dec 1;38(4):261-262. doi: 10.1097/YCT.0000000000000868. Epub 2022 Jul 19. No abstract available.
PubMed 35900079
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroconvulsive Therapy Versus Magnetic Seizure Therapy: Clinical and Cognitive Outcomes
- ClinicalTrials.gov ID
- NCT05054699
- Acronym / sponsor ID
- EMCODE / 29979220.4.0000.0068
- Conditions
- Major Depressive Disorder, Bipolar Depression
- Keywords
- Magnetic Seizure Therapy, Electroconvulsive Therapy, Depression, Major Depressive Disorder, Bipolar Depression, Cognition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 31 May 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MST | Experimental | Device: Magnetic Seizure TherapySubjects 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 |
| ECT | Active comparator | Device: Electroconvulsive TherapySubjects 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Seizure TherapyAlso: MSTSubjects 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 | Device | MST |
| Electroconvulsive TherapyAlso: ECTSubjects will receive a brief-pulse electrical stimulus (between 25 and 1008mC) under general anaesthesia using a ECT device | Device | ECT |
Primary outcome
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Derived from this study: PubMed 35900079Cretaz E, Bellini H, Gallucci-Neto J, Carneiro AM, Dos Santos LA, Miranda CS, Brunoni AR. Use of Magnetic Seizure Therapy for Treatment-Resistant Depression: A Case Series. J ECT. 2022 Dec 1;38(4):261-262. doi: 10.1097/YCT.0000000000000868. Epub 2022 Jul 19. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANDRE R BRUNONI principal investigator
FACULDADE DE MEDICINA DA USP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Magnetic Seizure Therapy and Electroconvulsive Therapy in people with Major Depressive Disorder and Bipolar Depression, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054699, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.