<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/NCT02246283</url>
  </required_header>
  <id_info>
    <org_study_id>Schizophrenia-Lifelong</org_study_id>
    <nct_id>NCT02246283</nct_id>
  </id_info>
  <brief_title>Schizophrenia for &quot;Life&quot; - a Registry and Interview Study Among Elderly With Lifelong Schizophrenia</brief_title>
  <official_title>Schizophrenia for &quot;Life&quot; - a Registry and Interview Study Among Elderly With Lifelong Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kjeld Andersen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Psychiatric Research Foundation in Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Danish Mental Health Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Danish Health Foundation (Helsefonden)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The non-profit foundation Trygfonden.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense Patient Data Explorative Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jeppe Juhl and Ovita Juhls Memorial Grant</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Butcher Max Wørzner and wife Inger Wørzner's Memorial Grant</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The elderly demographic is on the rise - and this includes elderly living with schizophrenia.&#xD;
      Yet very little is known about their lives, how they cope with their condition and how it&#xD;
      develops over time.&#xD;
&#xD;
      Research in this patient-group is sparse; overall there seem to be a tendency for elderly&#xD;
      patients to manifest fewer psychotic symptoms and experiencing an increase in the&#xD;
      psychological quality of life with older age. Opinions are divided on the degree and extent&#xD;
      to which this tendency reflects remission and/or recovery in older patients.&#xD;
&#xD;
      In order to identify factors associated with a positive outcome we:&#xD;
&#xD;
        -  Investigate the course and the outcomes of the illness over the lifespan, as well as the&#xD;
           life course and outcomes.&#xD;
&#xD;
        -  Investigate the current status of mental and physical health, quality of life as well as&#xD;
           functional competence of elderly (55+ yr) with schizophrenia.&#xD;
&#xD;
      Also the investigators&#xD;
&#xD;
      - Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type&#xD;
      1 diabetes (a chronic somatic illness).&#xD;
&#xD;
      This study will yield vital insights into how schizophrenia develops over time, isolating&#xD;
      factors that determine how well patients fare. The perspective is to advance knowledge of&#xD;
      elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the&#xD;
      interventions offered to this group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ageing with schizophrenia</measure>
    <time_frame>up to 45 years</time_frame>
    <description>Prognosis measured by use of healthcare system, use of medicine, co-morbidity, mortality, causes of mortality, and socio-demographic data, including highest level of education, years of employment/un-employment, use of health- and welfare services.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 month</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <enrollment type="Actual">10404</enrollment>
  <condition>Schizophrenia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Registry study: A nationwide register cohort study (1970-79) identifying psychiatric&#xD;
        admissions (aged 18-40), who were registered with a schizophrenia diagnosis. Several Danish&#xD;
        registers are applied.&#xD;
&#xD;
        Interview study: A cross-sectional survey where 150 randomly drawn surviving members of the&#xD;
        register cohort resident in the Region of Southern Denmark will be interviewed on the basis&#xD;
        of internationally validated assessment tools.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Initial schizophrenia diagnosis between the ages 18-40 (both incl) in the period 1970-1979&#xD;
        (both incl) Interview study: Residence in Region of Southern Denmark&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Interview study: Mental retardation&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Brink, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Unit of Psychiatry, Psychiatric Unit Odense - University function</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>July 16, 2018</last_update_submitted>
  <last_update_submitted_qc>July 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Kjeld Andersen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>elderly</keyword>
  <keyword>lifelong</keyword>
  <keyword>quality of life</keyword>
  <keyword>register</keyword>
  <keyword>questionaire</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/NCT02246283
org study id: Schizophrenia-Lifelong
nct id: NCT02246283
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The elderly demographic is on the rise - and this includes elderly living with schizophrenia.
      Yet very little is known about their lives, how they cope with their condition and how it
      develops over time.

      Research in this patient-group is sparse; overall there seem to be a tendency for elderly
      patients to manifest fewer psychotic symptoms and experiencing an increase in the
      psychological quality of life with older age. Opinions are divided on the degree and extent
      to which this tendency reflects remission and/or recovery in older patients.

      In order to identify factors associated with a positive outcome we:

        -  Investigate the course and the outcomes of the illness over the lifespan, as well as the
           life course and outcomes.

        -  Investigate the current status of mental and physical health, quality of life as well as
           functional competence of elderly (55+ yr) with schizophrenia.

      Also the investigators

      - Compare the trajectory and prognosis of schizophrenia (a chronic mental illness) with type
      1 diabetes (a chronic somatic illness).

      This study will yield vital insights into how schizophrenia develops over time, isolating
      factors that determine how well patients fare. The perspective is to advance knowledge of
      elderly with schizophrenia with a view to optimizing and increasing the effectiveness of the
      interventions offered to this group.
observational model: Cohort
time perspective: Retrospective
measure: Ageing with schizophrenia
time frame: up to 45 years
description: Prognosis measured by use of healthcare system, use of medicine, co-morbidity, mortality, causes of mortality, and socio-demographic data, including highest level of education, years of employment/un-employment, use of health- and welfare services.
measure: Quality of life
time frame: 1 month
description: Questionnaire
measure: Remission
time frame: 6 months
description: Questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 95 Years
healthy volunteers: No
last name: Maria Brink, MD
role: Principal Investigator
affiliation: University of Southern Denmark
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Kjeld Andersen
investigator title: Professor
mesh term: Schizophrenia