Metabolomics During ElectroConvulsivoTherapy

NCT05973643 | Recruiting

• 1 other identifier: 2023-A00548-37
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Major Depressive Episode; ECT

Keywords

1HNMR; Electroconvulsive Therapy; Major Depression

Outcome Measures

Primary Outcomes (1)

• Value the metabolic profile difference between the baseline and before the 6th session of ECT by blood metabolomics through 1HNMR

  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.

  up to 3 weeks

Secondary Outcomes (4)

• Measure the biological effect of one ECT session on the blood metabolome

  through first ECT session, an average of 1 week

• Compare the biological effect measured between the baseline and before the 1st, 6th and 12th session of ECT

  through study completion, up to 6 weeks

• Measure the variations of the metabolic signature according to the clinical response during the ECT treatment

  up to 10 weeks

• Look for a metabolic signature to discriminate between responder and non-responder patients before the 6 ECT sessions (i.e. the day of the 6th)

  through the sixth session, up 3 weeks

Study Arms (1)

Electroconvulsive therapy

OTHER

simple-blind, any adult patient presenting a characterized depressive episode in the context of unipolar major depressive disorder or bipolar disorder who consents and requires an ECT treatment. study including 50 patients.

Other: Electroconvulsive therapy

Interventions

Electroconvulsive therapy OTHER

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.

Electroconvulsive therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier le Vinatier

Bron, 69678, France

RECRUITING

Related Publications (4)

• Aberg-Wistedt A, Martensson B, Bertilsson L, Malmgren R. Electroconvulsive Therapy Effects on Cerebrospinal Fluid Monoamine Metabolites and Platelet Serotonin Uptake In Melancholia. Convuls Ther. 1986;2(2):91-98.

  PMID: 11940851 RESULT

• Abrams R, Essman WB, Taylor MA, Fink M. Concentration of 5-hydroxyindoleacetic acid, homovanillic acid, and tryptophan in the cerebrospinal fluid of depressed patients before and after ECT. Biol Psychiatry. 1976 Feb;11(1):85-90.

  PMID: 1260078 RESULT

• van Diermen L, van den Ameele S, Kamperman AM, Sabbe BCG, Vermeulen T, Schrijvers D, Birkenhager TK. Prediction of electroconvulsive therapy response and remission in major depression: meta-analysis. Br J Psychiatry. 2018 Feb;212(2):71-80. doi: 10.1192/bjp.2017.28.

  PMID: 29436330 RESULT

• Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Bond DJ, Frey BN, Sharma V, Goldstein BI, Rej S, Beaulieu S, Alda M, MacQueen G, Milev RV, Ravindran A, O'Donovan C, McIntosh D, Lam RW, Vazquez G, Kapczinski F, McIntyre RS, Kozicky J, Kanba S, Lafer B, Suppes T, Calabrese JR, Vieta E, Malhi G, Post RM, Berk M. Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder. Bipolar Disord. 2018 Mar;20(2):97-170. doi: 10.1111/bdi.12609. Epub 2018 Mar 14.

  PMID: 29536616 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

COSTEMALE-LACOSTE Jean-François, PH

CONTACT

(0)4 37 91 54 95; jean-francois.costemale-lacoste@ch-le-vinatier.fr

SARTELET Lydie

CONTACT

0437915531; lydie.sartelet@ch-le-vinatier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: simple-blind, any adult patient presenting a characterized depressive episode in the context of unipolar major depressive disorder or bipolar disorder who consents and requires an ECT treatment. study including 50 patients.

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 3, 2023
• Study Start: March 11, 2024
• Primary Completion: October 15, 2025
• Study Completion (Estimated): October 15, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)