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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through first ECT session, an average of 1 week |
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Inclusion Criteria:
Exclusion Criteria - Cannot be included in the study, people:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| COSTEMALE-LACOSTE Jean-François, PH | Contact | (0)4 37 91 54 95 | +33 | jean-francois.costemale-lacoste@ch-le-vinatier.fr |
| SARTELET Lydie | Contact | 0437915531 | +33 | lydie.sartelet@ch-le-vinatier.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier le Vinatier | Recruiting | Bron | 69678 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11940851 | Result | 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. | |
| 1260078 | 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. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004565 | Electroconvulsive Therapy |
| ID | Term |
|---|---|
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
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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.
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| 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. | through study completion, up to 6 weeks |
| 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. | 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) | Comparison of metabolic signatures obtained by very high field NMR between responder and non-responder patients before the 6th ECT session (V2) | through the sixth session, up 3 weeks |
| 29436330 | 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. |
| 29536616 | 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. |
| D011580 | Psychological Techniques |