Measuring blood metabolites during electroconvulsive therapy for depression
Study by 1H NMR of the Variations of the Metabolome During the Course of Electroconvulsive Therapy in Patients With Major Depressive Episode
NA · Hôpital le Vinatier · NCT05973643
This study is testing if changes in blood substances during electroconvulsive therapy can help predict how well the treatment works for people with major depression or bipolar disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hôpital le Vinatier (other) |
| Locations | 1 site (Bron) |
| Trial ID | NCT05973643 on ClinicalTrials.gov |
What this trial studies
This study aims to analyze changes in blood metabolites using 1H NMR spectroscopy at various time points during electroconvulsive therapy (ECT) in patients experiencing a major depressive episode. Participants will include individuals diagnosed with major depressive disorder or bipolar disorder who meet specific criteria for ECT treatment. Blood samples will be collected before and after the first session, as well as before the 6th, 12th, and final sessions of ECT, alongside assessments of depression severity and cognitive function. The goal is to explore whether metabolomic changes can predict treatment response and enhance understanding of ECT's biological mechanisms.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with major depressive disorder or bipolar disorder who are currently experiencing a major depressive episode and have not responded to at least two antidepressants.
Not a fit: Patients with schizophrenia spectrum disorders, neurological disorders, or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction of ECT response and better understanding of its mechanisms, potentially enhancing treatment outcomes for patients with severe depression.
How similar studies have performed: While ECT is a well-established treatment for severe depression, the use of metabolomics to predict response is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Bron
- Centre Hospitalier le Vinatier — Bron, France (RECRUITING)
Study contacts
- Study coordinator: COSTEMALE-LACOSTE Jean-François, PH
- Email: jean-francois.costemale-lacoste@ch-le-vinatier.fr
- Phone: (0)4 37 91 54 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Major Depressive Episode, ECT, 1HNMR, Electroconvulsive Therapy, Major Depression