<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/NCT03296384</url>
  </required_header>
  <id_info>
    <org_study_id>P100134</org_study_id>
    <nct_id>NCT03296384</nct_id>
  </id_info>
  <brief_title>Influence of Environmental Factors and Schizophrenia</brief_title>
  <acronym>Envschi</acronym>
  <official_title>Influence of Environmental Factors on the Prevalence, Risk and the Clinical Manifestations of Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut national d'étude démographique (INED)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>CPN (INSERM U894) CH Sainte-Anne - Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fondation FondaMental</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Schizophrenia is a chronic and severe mental disorder with a lifetime prevalence of about 1&#xD;
      per cent, the symptoms can be very disabling and causing a heavy medical and socioeconomic.&#xD;
&#xD;
      There are significant variations from one population to another. Clinical manifestations of&#xD;
      schizophrenia (symptoms, evolution, severity of disability) are highly variable. This&#xD;
      variability, both epidemiological and clinical, is due to genetic and environmental factors.&#xD;
&#xD;
      Environmental factors may be either risk factors or modifying factors (changing clinical&#xD;
      presentation but do not alter the risk of disease) for schizophrenia.&#xD;
&#xD;
      Environmental risk factors have been identified (eg: urbanity, cannabis, migration), but the&#xD;
      investigators don't know neither the components directly responsible, nor the mechanisms by&#xD;
      which they increase the risk of schizophrenia.&#xD;
&#xD;
      To date, there is no study has systematically evaluated the role of environmental modifying&#xD;
      factors in schizophrenia.&#xD;
&#xD;
      Environmental factors may be individual, unique to each person (eg cannabis, migration.), or&#xD;
      population-based (eg ethnic density, socio-economic difficulties.) The identification/&#xD;
      identifying of environmental risk factors or modifiers, both individual and population, may&#xD;
      have theoretical implications (understanding of etiopathogenic mechanisms) and practical&#xD;
      (implementation of preventive measures). The potential effectiveness of preventive measures&#xD;
      is even greater than the risk attributable to certain environmental factors is important.&#xD;
&#xD;
      Most studies on environmental factors in schizophrenia were conducted in Anglo-Saxon&#xD;
      countries and northern Europe, but no study of these risk factors has been conducted in&#xD;
      France.&#xD;
&#xD;
      There are important differences environment based on study populations, these results are not&#xD;
      generalizable to other countries, including France.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The prevalence of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV)) will be estimated from the census population-unit (unit TRIRIS INSEE)</measure>
    <time_frame>56 months, From March 2014 to November 2018</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The frequency of populational risk factors (insecurity, disorganization and density of migrants) will be assessed from the variables of INSEE</measure>
    <time_frame>56 months, From March 2014 to November 2018</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The frequency of individual risk factors (migration, cannabis, seasonality of birth, childhood trauma, social environment) will be measured from standardized assessments</measure>
    <time_frame>56 months, From March 2014 to November 2018</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Patients With Schizophrenia</condition>
  <condition>Relatives</condition>
  <arm_group>
    <arm_group_label>Patients with schizophrenia</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Relatives</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Clinical and environmental evaluation</intervention_name>
    <description>For schizophrenic's patients, specific assessment will be perform</description>
    <arm_group_label>Patients with schizophrenia</arm_group_label>
    <arm_group_label>Relatives</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All subjects&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Somatic state / condition and level of understanding (language, intellectual level)&#xD;
             compatible with the data collection (interview, self-administered questionnaires)&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  Diagnosis of schizophrenia according to DSM-IV criteria&#xD;
&#xD;
          -  Living in catchment areas&#xD;
&#xD;
        Non-Inclusion Criteria:&#xD;
&#xD;
        All subjects&#xD;
&#xD;
          -  Not affiliated to the social security scheme&#xD;
&#xD;
          -  inability to provide informed consent&#xD;
&#xD;
          -  Decompensated schizophrenic underway&#xD;
&#xD;
        Relatives&#xD;
&#xD;
          -  Protective Measures (tutor, curator)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Patients&#xD;
&#xD;
          -  The diagnosis of psychotic disorder is not confirmed by the synthesis of all clinical&#xD;
             data&#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_official>
    <last_name>Franck Schürhoff, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre-Michel Llorca, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Clermont Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Franck Schürhoff, MD PhD</last_name>
    <phone>(0)1 49 81 30 50</phone>
    <phone_ext>+33</phone_ext>
    <email>franck.schurhoff@inserm.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrei Szoke, MD</last_name>
    <phone>(0)1 49 81 32 90</phone>
    <phone_ext>+33</phone_ext>
    <email>andrei.szoke@inserm.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Henri Mondor Hospital</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 1, 2016</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>environmental factors</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/NCT03296384
org study id: P100134
nct id: NCT03296384
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Schizophrenia is a chronic and severe mental disorder with a lifetime prevalence of about 1
      per cent, the symptoms can be very disabling and causing a heavy medical and socioeconomic.

      There are significant variations from one population to another. Clinical manifestations of
      schizophrenia (symptoms, evolution, severity of disability) are highly variable. This
      variability, both epidemiological and clinical, is due to genetic and environmental factors.

      Environmental factors may be either risk factors or modifying factors (changing clinical
      presentation but do not alter the risk of disease) for schizophrenia.

      Environmental risk factors have been identified (eg: urbanity, cannabis, migration), but the
      investigators don't know neither the components directly responsible, nor the mechanisms by
      which they increase the risk of schizophrenia.

      To date, there is no study has systematically evaluated the role of environmental modifying
      factors in schizophrenia.

      Environmental factors may be individual, unique to each person (eg cannabis, migration.), or
      population-based (eg ethnic density, socio-economic difficulties.) The identification/
      identifying of environmental risk factors or modifiers, both individual and population, may
      have theoretical implications (understanding of etiopathogenic mechanisms) and practical
      (implementation of preventive measures). The potential effectiveness of preventive measures
      is even greater than the risk attributable to certain environmental factors is important.

      Most studies on environmental factors in schizophrenia were conducted in Anglo-Saxon
      countries and northern Europe, but no study of these risk factors has been conducted in
      France.

      There are important differences environment based on study populations, these results are not
      generalizable to other countries, including France.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The prevalence of schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV)) will be estimated from the census population-unit (unit TRIRIS INSEE)
time frame: 56 months, From March 2014 to November 2018
measure: The frequency of populational risk factors (insecurity, disorganization and density of migrants) will be assessed from the variables of INSEE
time frame: 56 months, From March 2014 to November 2018
measure: The frequency of individual risk factors (migration, cannabis, seasonality of birth, childhood trauma, social environment) will be measured from standardized assessments
time frame: 56 months, From March 2014 to November 2018
arm group label: Patients with schizophrenia
arm group type: Other
arm group label: Relatives
arm group type: Other
intervention type: Other
intervention name: Clinical and environmental evaluation
description: For schizophrenic's patients, specific assessment will be perform
arm group label: Patients with schizophrenia
arm group label: Relatives
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Franck Schürhoff, MD PhD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Pierre-Michel Llorca, MD PhD
role: Principal Investigator
affiliation: CHU de Clermont Ferrand
last name: Franck Schürhoff, MD PhD
phone: (0)1 49 81 30 50
phone ext: +33
email: franck.schurhoff@inserm.fr
last name: Andrei Szoke, MD
phone: (0)1 49 81 32 90
phone ext: +33
email: andrei.szoke@inserm.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Schizophrenia