<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/NCT04477434</url>
  </required_header>
  <id_info>
    <org_study_id>2035305v1</org_study_id>
    <nct_id>NCT04477434</nct_id>
  </id_info>
  <brief_title>French Observatory of ElectroConvulsive Therapy (ECT)</brief_title>
  <official_title>Observatoire National d'ElectroConvulsivoThérapie (ECT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Henri Laborit</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Henri Laborit</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>
      Since the 30s, ECT has been a psychiatric treatment mainly used for drug-resistant depressive&#xD;
      illnesses. Clinical studies have shown its therapeutic efficiency compared to standard&#xD;
      treatments also in other psychiatric illnesses. Although efficient, ECTs also induce side&#xD;
      effects. In France, there is currently no consensus on providing the suitest medical care. It&#xD;
      is therefore important to review our nowadays health care models in order to maintain and&#xD;
      improve the recommendations of the French National Agency for Accreditation and Evaluation in&#xD;
      Health, the last of which date from 1997! Within this context, this project has the dual&#xD;
      objective of (1) identifying ECT medical procedure in France and (2) developing research to&#xD;
      evaluate and to improve the effectiveness of this treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 24, 2018</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ECT efficiency on patients</measure>
    <time_frame>2018-2022</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Mental Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients receiving ECT as part of their medical treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients consecutively referred for ECT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not specified&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU d'Angers : Site Larrey</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marine ROZET, MD</last_name>
      <phone>0033 2 41 35 36 37</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Mirambeau</name>
      <address>
        <city>Anglet</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christophe DAUDET, MD</last_name>
      <phone>0033 5 59 52 33 00</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHS de Montfavet</name>
      <address>
        <city>Avignon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hosni EL OUAHCHI, MD</last_name>
      <phone>0033 4 90 03 90 00</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Cote Basque</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Antoine OLIVEIRA, MD</last_name>
      <phone>0033 5 59 44 35 35</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondation bon sauveur</name>
      <address>
        <city>Bégard</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Claire BERNARD, MD</last_name>
      <phone>0033 2 96 45 20 10</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre de crise Esquirol</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pierrick LEBAIN, MD</last_name>
    </contact>
    <contact_backup>
      <phone>0033 2 31 06 50 62</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CHU Gabriel Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Clémence MOREAU, MD</last_name>
    </contact>
    <contact_backup>
      <phone>0033 4 73 75 07 50</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CH La Chartreuse</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-Claude GIROD, MD</last_name>
      <phone>0033 3 80 42 48 48</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique du domaine de Vontes</name>
      <address>
        <city>Esvres-sur-Indre</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabelle RAMAGE, MD</last_name>
      <phone>0033 2 47 34 15 15</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique de Pen-An-Dalar</name>
      <address>
        <city>Guipavas</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Erwan LUVEN, MD</last_name>
      <phone>0033 2 98 84 76 25</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Marius Lacroix</name>
      <address>
        <city>La Rochelle</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Michel DURAND, MD</last_name>
      <phone>0033 5 46 45 50 50</phone>
      <email>Marius-Lacroix@ch-larochelle.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CUMP Océan Indien</name>
      <address>
        <city>La Réunion</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Erick GOKALSING, MD</last_name>
      <phone>00262 262 42 72 72</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Césame</name>
      <address>
        <city>Les ponts de Ce</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Isabelle BOUYER, MD</last_name>
      <phone>0033 2 41 80 79 08</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH de Mayenne</name>
      <address>
        <city>Mayenne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mathilde SIX, MD</last_name>
      <phone>0033 2 43 08 73 00</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHR Metz-Thionville</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pascal LE VAOU, MD</last_name>
      <phone>0033 3 82 55 82 55</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH psy de la drôme Vivarais</name>
      <address>
        <city>Monteléger</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pierre COURVOISIER, MD</last_name>
      <phone>0033 4 75 75 60 60</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHS la Colombiere</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jérome ATTAL, MD</last_name>
      <phone>0033 4 67 33 67 33</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Saint Roch</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent GUGENHEIM, MD</last_name>
      <phone>0033 4 92 03 77 77</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Sainte Anne</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marion PLAZE, MD</last_name>
      <phone>00 33 1 45 65 80 00</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Henri Laborit</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diane LEVY-CHAVAGNAT, MD</last_name>
      <phone>00 335 49 44 58 56</phone>
      <email>halima.rakhila@ch-poitiers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHI Redon-Carentoir</name>
      <address>
        <city>Redon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sidi-Mohammed BENSENANE, MD</last_name>
      <phone>0033 2 99 71 71 71</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Guillaume Regnier</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique DRAPIER, MD</last_name>
      <phone>0033 2 99 33 39 00</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH du Rouvray</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maud ROTHARMEL, MD</last_name>
      <phone>0033 4 73 75 07 50</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Epsm du Morbihan</name>
      <address>
        <city>Saint-Avé</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François-Alexis RICHARD, MD</last_name>
      <phone>0033 2 97 54 49 49</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Clinique Villa du Parc</name>
      <address>
        <city>Saujon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier DUBOIS, MD</last_name>
      <phone>0033 5 46 23 50 00</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Civil 1</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Atifa KORICHE, MD</last_name>
    </contact>
    <contact_backup>
      <phone>0033 3 88 11 67 68</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>CH Nord Deux Sèvres</name>
      <address>
        <city>Thouars</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Salima BRAIK, MD</last_name>
      <phone>0033 5 49 68 49 68</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHITS CH Sainte Musse</name>
      <address>
        <city>Toulon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-Luc BARTOLI, MD</last_name>
      <phone>0033 4 94 14 50 00</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Purpan</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Antoine YRONDI, MD</last_name>
      <phone>0033 5 61 77 22 33</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>CPU de Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maxime BONNIN, MD</last_name>
      <phone>0033 2 34 37 89 47</phone>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04477434
org study id: 2035305v1
nct id: NCT04477434
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since the 30s, ECT has been a psychiatric treatment mainly used for drug-resistant depressive
      illnesses. Clinical studies have shown its therapeutic efficiency compared to standard
      treatments also in other psychiatric illnesses. Although efficient, ECTs also induce side
      effects. In France, there is currently no consensus on providing the suitest medical care. It
      is therefore important to review our nowadays health care models in order to maintain and
      improve the recommendations of the French National Agency for Accreditation and Evaluation in
      Health, the last of which date from 1997! Within this context, this project has the dual
      objective of (1) identifying ECT medical procedure in France and (2) developing research to
      evaluate and to improve the effectiveness of this treatment.
observational model: Cohort
time perspective: Prospective
measure: ECT efficiency on patients
time frame: 2018-2022
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
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status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
contact backup: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Mental Disorders
sharing ipd: Undecided