Metabolomics During ElectroConvulsivoTherapy
Recruiting · NCT05973643 · Interventional (participants receive a specific treatment) · Lead sponsor: Hôpital le Vinatier
View the official record on ClinicalTrials.gov →Interventions studied
Electroconvulsive therapy
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Centre Hospitalier le Vinatier - Bron, France