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

Major Depressive Disorder Clinical Trial

— EMCODE  

Official title:

Electroconvulsive Therapy Versus Magnetic Seizure Therapy: Clinical and Cognitive Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054699
• Other study ID #: 29979220.4.0000.0068
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 31, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2021
• Source: University of Sao Paulo
• Contact: Andre Brunoni, MD, PhD
• Phone: +55-11-2661-8159
• Email: brunoni[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry, HC-FMUSP	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	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	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.	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	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.	Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.