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NCT Number: NCT05973643

Metabolomics During ElectroConvulsivoTherapy

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.

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Key information

Conditions

Major Depressive Episode Depressive Disorder Depressive Disorder, Major ECT Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: up to 3 weeks

    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.

Secondary outcomes

  1. Measure the biological effect of one ECT session on the blood metabolome

    Time frame: through first ECT session, an average of 1 week

    Comparison of quantitative and qualitative measurements of metabolites and metabolic signatures obtained by 1HNMR between baseline and the first ECT by observing either a clinical response or a clinical remission by discriminating remitters and no remitters patients.

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

    Time frame: through study completion, up to 6 weeks

    Comparison of quantitative and qualitative measurements of metabolites and metabolic signatures obtained by 1HNMR between baseline and the first ECT by observing either a clinical response or a clinical remission by discriminating remitters and no remitters patients. The clinical response is defined by the decrease of 50% on the MADRS scale. The clinical remission is defined by a score less than or equal to 10 on the MADRS scale.

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

    Time frame: up to 10 weeks

    Comparison of quantitative and qualitative measures of metabolites taken separately and metabolic signatures obtained by 1H NMR according to the clinical response on the MADRS scale (the overall score thus ranges from 0 to 60) throughout the course of ECT. The clinical response is defined by the decrease of 50% on the MADRS scale. The clinical remission is defined by a score less than or equal to 10 on the MADRS scale.

  4. 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)

    Time frame: through the sixth session, up 3 weeks

    Comparison of metabolic signatures obtained by very high field NMR between responder and non-responder patients before the 6th ECT session (V2)

Study contacts

Contact information is provided by the study sponsor or research team.

COSTEMALE-LACOSTE Jean-François, PH

CONTACT

[email protected]

(0)4 37 91 54 95 ext. +33

SARTELET Lydie

CONTACT

[email protected]

0437915531 ext. +33

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: METECT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 3, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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