<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/NCT01689389</url>
  </required_header>
  <id_info>
    <org_study_id>NIS-NFR-SER-2012/1</org_study_id>
    <nct_id>NCT01689389</nct_id>
  </id_info>
  <brief_title>Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France. An Observational Study</brief_title>
  <official_title>Description of the Use of Quetiapine Extended Release (XR) in Real-life Practice in France</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to describe patient characteristics (demographic and clinical) and&#xD;
      the patterns of use of Quetiapine XR in patients receiving the drug for the first time in&#xD;
      real-life practice regardless the final diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Description of the use of Quetiapine Extended Release (XR) in real-life practice in France&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Descriptive analysis of variables related with how the drug is prescribed and used by the patient.</measure>
    <time_frame>At inclusion</time_frame>
    <description>Variables related with how the drug is prescribed and used by the patient [doses in mg/day, titration (yes/no), time of administration (morning/middle of the day/afternoon/evening), concomitant treatments] are going to be described.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Description of patient's socio-demographics profile.</measure>
    <time_frame>At inclusion</time_frame>
    <description>Age, gender, educational and professional status, co-habitation are going to be described.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Descriptive analysis of medical history.</measure>
    <time_frame>At inclusion</time_frame>
    <description>Diagnosis, family history of psychiatric disorders, number of suicidal attempts within the last 12 months, co-morbidities, treatments received during the last 12 months, laboratory and exam data will be included in the description.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of the disease measured by Clinical Global Impressions Scale - Severity (CGI-S).</measure>
    <time_frame>At inclusion</time_frame>
    <description>The Clinical Global Impressions Scale - Severity (CGI-S) assesses the clinician's impression of the current state of the patient's illness.&#xD;
The following scores can be given: 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Global Impressions Scale - Severity (CGI-S) during the treatment.</measure>
    <time_frame>From baseline to 12 months</time_frame>
    <description>The Clinical Global Impressions Scale - Severity (CGI-S) assesses the clinician's impression of the current state of the patient's illness.&#xD;
The following scores can be given: 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.</measure>
    <time_frame>From baseline to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive analysis of the treatment changes: drug switches.</measure>
    <time_frame>From baseline to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.</measure>
    <time_frame>From baseline to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Body Mass Index (BMI).</measure>
    <time_frame>From baseline to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory tests- cholesterol.</measure>
    <time_frame>From baseline to 12 months</time_frame>
    <description>Blood test- cholesterol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive analysis of all adverse events.</measure>
    <time_frame>From baseline to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relapses (only for the schizophrenia subpopulation).</measure>
    <time_frame>From baseline to 12 months</time_frame>
    <description>New psychiatric hospitalisation, deterioration of the CGI-S (Clinical Global Impressions Scale - Severity) by at least 3 points for a baseline score of 1, at least 2 points for a baseline score of 2 or 3, at least 1 point for a baseline score of 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory tests- glycemia.</measure>
    <time_frame>From baseline to 12 months</time_frame>
    <description>Blood test- glycemia.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">2292</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Bipolar Episodes</condition>
  <arm_group>
    <arm_group_label>Main study population</arm_group_label>
    <description>All eligible patients receiving Quetiapine XR for the first time in the inclusion period regardless the diagnosed disease or the patients' age.&#xD;
Patients aged 18 years and over and diagnosed with bipolar disorder or schizophrenia according to DSM-IV criteria will be followed during 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Schizophrenia SoC sample</arm_group_label>
    <description>Patients would have to be prescribed for the first time with a new (not used during the preceding 3 months) atypical antipsychotic other than Quetiapine XR (irrespective this new atypical antipsychotic is preceded or not by another atypical antipsychotic).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bipolar SoC sample</arm_group_label>
    <description>Patients would have to be prescribed a new (not used during the preceding 3 months) antidepressant [N06A], antipsychotic (other than Quetiapine XR) [N05A] or mood stabilizer (including lithium [N05AN], valproate [N03AG01], and lamotrigine [N03AX09].</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Hospital, clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New patients treated with Xeroquel XR&#xD;
&#xD;
          -  Patients aged 18 years and over&#xD;
&#xD;
          -  Diagnosis of bipolar disorder or schizophrenia according to DSM-IV criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient included in a therapeutic trial (Huriet-Serusclat Act)&#xD;
&#xD;
          -  Patient refusing to participate in the study&#xD;
&#xD;
          -  Pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bruno FALISSARD, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre-Michel LLORCA, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Argenteuil Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Belley</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Castelmaurou</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reserach Site</name>
      <address>
        <city>Cavaillon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Les Mureaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nimes Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research SIte</name>
      <address>
        <city>Obernai</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saintes Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>research Site</name>
      <address>
        <city>St Dizier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Egreve Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ussel Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=928&amp;filename=NIS-NFR-SER-2012-1_SUMMARY_SYNOPSIS.pdf</url>
    <description>NIS-NFR-SER-2012/1 SUMMARY SYNOPSIS</description>
  </link>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>December 14, 2015</last_update_submitted>
  <last_update_submitted_qc>December 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Bipolar episodes</keyword>
  <keyword>France</keyword>
  <keyword>Xeroquel</keyword>
  <keyword>Real-life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01689389
org study id: NIS-NFR-SER-2012/1
nct id: NCT01689389
lead sponsor: 
has dmc: No
The aim of the study is to describe patient characteristics (demographic and clinical) and
      the patterns of use of Quetiapine XR in patients receiving the drug for the first time in
      real-life practice regardless the final diagnosis.
Description of the use of Quetiapine Extended Release (XR) in real-life practice in France
observational model: Cohort
time perspective: Prospective
measure: Descriptive analysis of variables related with how the drug is prescribed and used by the patient.
time frame: At inclusion
description: Variables related with how the drug is prescribed and used by the patient [doses in mg/day, titration (yes/no), time of administration (morning/middle of the day/afternoon/evening), concomitant treatments] are going to be described.
measure: Description of patient's socio-demographics profile.
time frame: At inclusion
description: Age, gender, educational and professional status, co-habitation are going to be described.
measure: Descriptive analysis of medical history.
time frame: At inclusion
description: Diagnosis, family history of psychiatric disorders, number of suicidal attempts within the last 12 months, co-morbidities, treatments received during the last 12 months, laboratory and exam data will be included in the description.
measure: Severity of the disease measured by Clinical Global Impressions Scale - Severity (CGI-S).
time frame: At inclusion
description: The Clinical Global Impressions Scale - Severity (CGI-S) assesses the clinician's impression of the current state of the patient's illness.
The following scores can be given: 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients.
measure: Change in Clinical Global Impressions Scale - Severity (CGI-S) during the treatment.
time frame: From baseline to 12 months
description: The Clinical Global Impressions Scale - Severity (CGI-S) assesses the clinician's impression of the current state of the patient's illness.
The following scores can be given: 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, and 7=among the most extremely ill patients.
measure: Quetiapine XR and concomitant treatment stop, stop date, reasons to stop, restart, restart date, reasons to restart.
time frame: From baseline to 12 months
measure: Descriptive analysis of the treatment changes: drug switches.
time frame: From baseline to 12 months
measure: Description of patterns of healthcare management resource use related with psychiatric disorders under investigation.
time frame: From baseline to 12 months
measure: Change in Body Mass Index (BMI).
time frame: From baseline to 12 months
measure: Laboratory tests- cholesterol.
time frame: From baseline to 12 months
description: Blood test- cholesterol.
measure: Descriptive analysis of all adverse events.
time frame: From baseline to 12 months
measure: Relapses (only for the schizophrenia subpopulation).
time frame: From baseline to 12 months
description: New psychiatric hospitalisation, deterioration of the CGI-S (Clinical Global Impressions Scale - Severity) by at least 3 points for a baseline score of 1, at least 2 points for a baseline score of 2 or 3, at least 1 point for a baseline score of 4.
measure: Laboratory tests- glycemia.
time frame: From baseline to 12 months
description: Blood test- glycemia.
arm group label: Main study population
description: All eligible patients receiving Quetiapine XR for the first time in the inclusion period regardless the diagnosed disease or the patients' age.
Patients aged 18 years and over and diagnosed with bipolar disorder or schizophrenia according to DSM-IV criteria will be followed during 12 months.
arm group label: Schizophrenia SoC sample
description: Patients would have to be prescribed for the first time with a new (not used during the preceding 3 months) atypical antipsychotic other than Quetiapine XR (irrespective this new atypical antipsychotic is preceded or not by another atypical antipsychotic).
arm group label: Bipolar SoC sample
description: Patients would have to be prescribed a new (not used during the preceding 3 months) antidepressant [N06A], antipsychotic (other than Quetiapine XR) [N05A] or mood stabilizer (including lithium [N05AN], valproate [N03AG01], and lamotrigine [N03AX09].
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Bruno FALISSARD, Pr
role: Principal Investigator
affiliation: Paris
last name: Pierre-Michel LLORCA, Pr
role: Principal Investigator
affiliation: Clermont-Ferrand
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country: France
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=928&filename=NIS-NFR-SER-2012-1_SUMMARY_SYNOPSIS.pdf
description: NIS-NFR-SER-2012/1 SUMMARY SYNOPSIS
responsible party type: Sponsor
mesh term: Schizophrenia