xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05973643</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A00548-37</org_study_id>
      <nct_id>NCT05973643</nct_id>
    </id_info>
    <brief_title>Metabolomics During ElectroConvulsivoTherapy</brief_title>
    <acronym>METECT</acronym>
    <official_title>Study by 1H NMR of the Variations of the Metabolome During the Course of Electroconvulsive Therapy in Patients With Major Depressive Episode</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hôpital le Vinatier</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hôpital le Vinatier</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Investigators will measure the variation of blood Metabolome through 1H NMR at several time&#xD;
        points during the course of electroconvulsivetherapy in patients with a major depressive&#xD;
        episode. Patients with a major depressive disorder or a bipolar disorder and a current major&#xD;
        depressive episode will be included in this study. Investigators hypothesized that Metabolome&#xD;
        could be a source to predict response during ECT and to help understanding underlying&#xD;
        biological mechanisms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Biological signatures of blood metabolome will be measure before and after the first session&#xD;
        of electroconvulsivetherapy, and during the course, before the 6th, 12th and the last&#xD;
        sessions. Proton Nuclear Magnetic Resonance spectroscopy will be used to measure metabolites&#xD;
        in blood sample. In parallel, at each time point, depression severity (MADRS and BDI),&#xD;
        Perceived severity (CGI), global functioning (EGF), convulsive characteristics and cognitive&#xD;
        tolerance (MOCA) will be measure, at each time point.&#xD;
  &#xD;
        The aim of this study is to determine whether 1HNMR could help to understanding metabolic&#xD;
        ways and predict response to ECT in patients with a current Major Depressive Episode (MDE) in&#xD;
        Major Depressive Disorder (MDD) and in Bipolar Disorder (BD).&#xD;
  &#xD;
        To date, scientific community knows that ECT is a safety and efficacy treatment in MDE&#xD;
        particularly resistant or severe, but scientific community knows little about its mechanism&#xD;
        of action.&#xD;
  &#xD;
        The investigators hypothesize that 1HNMR could help to go further.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_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.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Value the metabolic profile difference between the baseline and before the 6th session of ECT by blood metabolomics through 1HNMR</measure>
      <time_frame>up to 3 weeks</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measure the biological effect of one ECT session on the blood metabolome</measure>
      <time_frame>through first ECT session, an average of 1 week</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare the biological effect measured between the baseline and before the 1st, 6th and 12th session of ECT</measure>
      <time_frame>through study completion, up to 6 weeks</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Measure the variations of the metabolic signature according to the clinical response during the ECT treatment</measure>
      <time_frame>up to 10 weeks</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>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)</measure>
      <time_frame>through the sixth session, up 3 weeks</time_frame>
      <description>Comparison of metabolic signatures obtained by very high field NMR between responder and non-responder patients before the 6th ECT session (V2)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Major Depressive Episode</condition>
    <condition>ECT</condition>
    <arm_group>
      <arm_group_label>Electroconvulsive therapy</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electroconvulsive therapy</intervention_name>
      <description>Electroconvulsive therapy is administered through electrodes positioned bilaterally (bitemporal) or unilaterally (or fronto-temporal) on the frontotemporal region under anesthesia.&#xD;
  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.&#xD;
  Blood samples will be done during the anesthesia process.</description>
      <arm_group_label>Electroconvulsive therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Major depressive episode according to DSM-5 criteria&#xD;
  &#xD;
            -  Diagnosis of major depressive disorder or bipolar disorder&#xD;
  &#xD;
            -  MADRS score &gt;22&#xD;
  &#xD;
            -  having given written, free and informed consent&#xD;
  &#xD;
            -  without protective measures&#xD;
  &#xD;
            -  resistance criterion defined as failure of 2 antidepressants at an effective dose for&#xD;
               a minimum of 6 weeks&#xD;
  &#xD;
            -  current major depressive episode according to DSM-5 criteria with indication of&#xD;
               treatment by ECT cure&#xD;
  &#xD;
          Exclusion Criteria - Cannot be included in the study, people:&#xD;
  &#xD;
            -  whose consent is not admissible or who refuse to participate in the study&#xD;
  &#xD;
            -  deprived of liberty by judicial or administrative decision&#xD;
  &#xD;
            -  For which there is a particular risk contraindicating the cure of ECT&#xD;
  &#xD;
            -  Suffering from schizophrenia spectrum disorders or persistent delusional disorder as&#xD;
               described by DSM-5 Criterion D for Major Depressive Disorder&#xD;
  &#xD;
            -  suffering from neurological disorders (such as patients suffering from multiple&#xD;
               sclerosis, epilepsy, encephalitis, etc.) and/or neurodegenerative disorders (such as&#xD;
               Parkinson's disease, Alzheimer's disease or related diseases, etc.) as described by&#xD;
               criterion C of the major depressive disorder listed in the DSM-5&#xD;
  &#xD;
            -  suffering from an acute or chronic systemic inflammatory disease requiring specific&#xD;
               treatment with immunomodulators or suppressors. As well as any recurrent inflammatory&#xD;
               disease requiring specific management, and which may lead to a differential diagnosis&#xD;
               of the characterized depressive episode as described by criterion C listed in the&#xD;
               DSM-5&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>COSTEMALE-LACOSTE Jean-François, PH</last_name>
      <phone>(0)4 37 91 54 95</phone>
      <phone_ext>+33</phone_ext>
      <email>jean-francois.costemale-lacoste@ch-le-vinatier.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>SARTELET Lydie</last_name>
      <phone>0437915531</phone>
      <phone_ext>+33</phone_ext>
      <email>lydie.sartelet@ch-le-vinatier.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre Hospitalier le Vinatier</name>
        <address>
          <city>Bron</city>
          <zip>69678</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <results_reference>
      <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.</citation>
      <PMID>11940851</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>1260078</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>29436330</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>29536616</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>1HNMR</keyword>
    <keyword>Electroconvulsive Therapy</keyword>
    <keyword>Major Depression</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depressive Disorder, Major</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05973643
  org study id: 2023-A00548-37
  nct id: NCT05973643
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention 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.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 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
  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.
  measure: Measure the biological effect of one ECT session on the blood metabolome
  time frame: through first ECT session, an average of 1 week
  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.
  measure: 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
  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.
  measure: Measure the variations of the metabolic signature according to the clinical response during the ECT treatment
  time frame: up to 10 weeks
  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.
  measure: 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
  description: Comparison of metabolic signatures obtained by very high field NMR between responder and non-responder patients before the 6th ECT session (V2)
  arm group label: Electroconvulsive therapy
  arm group type: Other
  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: Electroconvulsive therapy
  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.
  arm group label: Electroconvulsive therapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: COSTEMALE-LACOSTE Jean-François, PH
  phone: (0)4 37 91 54 95
  phone ext: +33
  email: jean-francois.costemale-lacoste@ch-le-vinatier.fr
  last name: SARTELET Lydie
  phone: 0437915531
  phone ext: +33
  email: lydie.sartelet@ch-le-vinatier.fr
  facility: 
  country: France
  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.
  PMID: 11940851
  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.
  PMID: 1260078
  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.
  PMID: 29436330
  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.
  PMID: 29536616
  responsible party type: Sponsor
  mesh term: Depressive Disorder, Major
  sharing ipd: No