Metabolomics During ElectroConvulsivoTherapy (METECT)

Hôpital le Vinatier

Status: Enrolling

Conditions: Major Depressive Episode; ECT

Treatments: Other: Electroconvulsive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05973643

2023-A00548-37

Details and patient eligibility

About

Investigators will measure the variation of blood Metabolome through 1H NMR at several time points during the course of electroconvulsivetherapy in patients with a major depressive episode. Patients with a major depressive disorder or a bipolar disorder and a current major depressive episode will be included in this study. Investigators hypothesized that Metabolome could be a source to predict response during ECT and to help understanding underlying biological mechanisms.

Full description

Biological signatures of blood metabolome will be measure before and after the first session of electroconvulsivetherapy, and during the course, before the 6th, 12th and the last sessions. Proton Nuclear Magnetic Resonance spectroscopy will be used to measure metabolites in blood sample. In parallel, at each time point, depression severity (MADRS and BDI), Perceived severity (CGI), global functioning (EGF), convulsive characteristics and cognitive tolerance (MOCA) will be measure, at each time point.

The aim of this study is to determine whether 1HNMR could help to understanding metabolic ways and predict response to ECT in patients with a current Major Depressive Episode (MDE) in Major Depressive Disorder (MDD) and in Bipolar Disorder (BD).

To date, scientific community knows that ECT is a safety and efficacy treatment in MDE particularly resistant or severe, but scientific community knows little about its mechanism of action.

The investigators hypothesize that 1HNMR could help to go further.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Major depressive episode according to DSM-5 criteria
• Diagnosis of major depressive disorder or bipolar disorder
• MADRS score >22
• having given written, free and informed consent
• without protective measures
• resistance criterion defined as failure of 2 antidepressants at an effective dose for a minimum of 6 weeks
• current major depressive episode according to DSM-5 criteria with indication of treatment by ECT cure

Exclusion Criteria - Cannot be included in the study, people:

• whose consent is not admissible or who refuse to participate in the study
• deprived of liberty by judicial or administrative decision
• For which there is a particular risk contraindicating the cure of ECT
• Suffering from schizophrenia spectrum disorders or persistent delusional disorder as described by DSM-5 Criterion D for Major Depressive Disorder
• suffering from neurological disorders (such as patients suffering from multiple sclerosis, epilepsy, encephalitis, etc.) and/or neurodegenerative disorders (such as Parkinson's disease, Alzheimer's disease or related diseases, etc.) as described by criterion C of the major depressive disorder listed in the DSM-5
• suffering from an acute or chronic systemic inflammatory disease requiring specific treatment with immunomodulators or suppressors. As well as any recurrent inflammatory disease requiring specific management, and which may lead to a differential diagnosis of the characterized depressive episode as described by criterion C listed in the DSM-5

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Electroconvulsive therapy

Other group

Description:

simple-blind, any adult patient presenting a characterized depressive episode in the context of unipolar major depressive disorder or bipolar disorder who consents and requires an ECT treatment. study including 50 patients.

Treatment:

Other: Electroconvulsive therapy