NCT05973643

Metabolomics During ElectroConvulsivoTherapy

Study by 1H NMR of the Variations of the Metabolome During the Course of Electroconvulsive Therapy in Patients With Major Depressive Episode

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Major Depressive Episode
• ECT

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2024-03-11
• Primary completion: 2025-10-15
• Completion: 2026-10-15
• First posted: 2023-08-03
• Last updated: 2025-07-24

Locations

1 site across 1 country: France