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

NCT05054699 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 29979220.4.0000.0068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Major Depressive Disorder; Bipolar Depression

Keywords

Magnetic Seizure Therapy; Electroconvulsive Therapy; Depression; Major Depressive Disorder; Bipolar Depression; Cognition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.

Study Arms (2)

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

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

Device: Electroconvulsive Therapy

Interventions

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

Also known as: MST

MST

Electroconvulsive Therapy DEVICE

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

Also known as: ECT

ECT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Institute of Psychiatry, HC-FMUSP

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 35900079 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• ANDRE R BRUNONI

  FACULDADE DE MEDICINA DA USP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2021
• First Posted: September 23, 2021
• Study Start: May 31, 2021
• Primary Completion: January 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)