Clinical trial NCT05054699: Electro-Magnetic Convulsive Therapies for Depression: a Non-inferiority Study
Official title: Electroconvulsive Therapy Versus Magnetic Seizure Therapy: Clinical and Cognitive Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Bipolar Depression
Keywords: Magnetic Seizure Therapy
Electroconvulsive Therapy
Depression
Major Depressive Disorder
Bipolar Depression
Cognition
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2021-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms
timeFrame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
measure: Biographical memory
timeFrame: 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:
measure: Depressive Symptoms
timeFrame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
measure: Depressive Symptoms
timeFrame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
measure: Suicidal Thoughts
timeFrame: Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Institute of Psychiatry, HC-FMUSP
state: SP
Study officials:
affiliation: FACULDADE DE MEDICINA DA USP
name: ANDRE R BRUNONI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.