Back to resultsMetabolomics During ElectroConvulsivoTherapy (METECT)
Primary Purpose
Major Depressive Episode, ECT
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroconvulsive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Episode focused on measuring 1HNMR, Electroconvulsive Therapy, Major Depression
Eligibility 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
Sites / Locations
- Centre Hospitalier le Vinatier
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Electroconvulsive therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05973643
Brief Title
Metabolomics During ElectroConvulsivoTherapy
Acronym
METECT
Official Title
Study by 1H NMR of the Variations of the Metabolome During the Course of Electroconvulsive Therapy in Patients With Major Depressive Episode
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Episode, ECT
Keywords
1HNMR, Electroconvulsive Therapy, Major Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroconvulsive therapy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electroconvulsive therapy
Intervention Description
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 Outcome Measure Information:
Title
Value the metabolic profile difference between the baseline and before the 6th session of ECT by blood metabolomics through 1HNMR
Description
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 weeks
Secondary Outcome Measure Information:
Title
Measure the biological effect of one ECT session on the blood metabolome
Description
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 week
Title
Compare the biological effect measured between the baseline and before the 1st, 6th and 12th session of ECT
Description
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 weeks
Title
Measure the variations of the metabolic signature according to the clinical response during the ECT treatment
Description
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 weeks
Title
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)
Description
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 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
COSTEMALE-LACOSTE Jean-François, PH
Phone
(0)4 37 91 54 95
Ext
+33
Email
jean-francois.costemale-lacoste@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
SARTELET Lydie
Phone
0437915531
Ext
+33
Email
lydie.sartelet@ch-le-vinatier.fr
Facility Information:
Facility Name
Centre Hospitalier le Vinatier
City
Bron
ZIP/Postal Code
69678
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11940851
Citation
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.
Results Reference
result
PubMed Identifier
1260078
Citation
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.
Results Reference
result
PubMed Identifier
29436330
Citation
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. Erratum In: Br J Psychiatry. 2018 May;212(5):322.
Results Reference
result
PubMed Identifier
29536616
Citation
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.
Results Reference
result
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Metabolomics During ElectroConvulsivoTherapy
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