Status:
RECRUITING
Metabolomics During ElectroConvulsivoTherapy
Lead Sponsor:
Hôpital le Vinatier
Conditions:
Major Depressive Episode
ECT
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 w...
Detailed 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 Nucl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05973643
Start Date
March 11 2024
End Date
October 15 2026
Last Update
July 24 2025
Active Locations (1)
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1
Centre Hospitalier le Vinatier
Bron, France, 69678