Metabolomics During ElectroConvulsivoTherapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHôpital le Vinatier
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Electroconvulsive therapy
Other interventionElectroconvulsive 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Electroconvulsive therapyOther 1 intervention
Trial outcomes
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.
Time frame
up to 3 weeksSecondary outcomes
1
Measure the biological effect of one ECT session on the blood metabolome
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.
Time frame
through first ECT session, an average of 1 week2
Compare the biological effect measured between the baseline and before the 1st, 6th and 12th session of ECT
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.
Time frame
through study completion, up to 6 weeks3
Measure the variations of the metabolic signature according to the clinical response during the ECT treatment
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.
Time frame
up to 10 weeks4
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)
Comparison of metabolic signatures obtained by very high field NMR between responder and non-responder patients before the 6th ECT session (V2)
Time frame
through the sixth session, up 3 weeksSponsors and contacts
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Source ClinicalTrials.gov