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Clinical Trials in France / NCT05973643
Recruiting Not applicable

Metabolomics During ElectroConvulsivoTherapy

NCT05973643 · tracked via the Priya Life Science France tracker
Sponsor
Hôpital le Vinatier
Phase
Not applicable
Started
2024-03-11
Last updated
2025-07-24

Condition(s) studied

Major Depressive EpisodeECT

Investigational drug(s) / intervention(s)

Electroconvulsive therapy

Electroconvulsive therapy: Electroconvulsive therapy is administered through electrodes positioned bilaterally (bitemporal) or unilaterally (or fronto-temporal) on the frontotemporal region under anesthesia. The stimulation dose is determined by titration method, during the first ECT session. An ECT cure corresponding from 12 to 20 sessions of ECT. Patients will receive 2 sessions a week. Blood samples will be done during the anesthesia process.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Value the metabolic profile difference between the baseline and before the 6th session of ECT by blood metabolomics through 1HNMR — up to 3 weeks
    identify variations in the metabolome by measuring the metabolome in the blood of patients treated for depressive episodes or bipolar disorder by identifying the metabolic profiles associated with the medical response to ECT between the Baseline and before the sixth ECT session.

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier le Vinatier Bron France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05973643 on ClinicalTrials.gov ↗ ← All trials in France