<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/NCT03040505</url>
  </required_header>
  <id_info>
    <org_study_id>6527</org_study_id>
    <nct_id>NCT03040505</nct_id>
  </id_info>
  <brief_title>Future Mental Projections in Schizophrenia</brief_title>
  <acronym>FutureProSchiz</acronym>
  <official_title>Future Mental Projections in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      The aim of the study is to investigate temporal organization of future thinking in patients&#xD;
      with schizophrenia. Patients and control participants will be asked to envision and briefly&#xD;
      describe ten personal future events using a cue-words list. Then they will be asked to&#xD;
      describe everything that came to their minds (i.e. to think aloud) while they attempted to&#xD;
      determine when an event will likely occur. The investigators will compare the proportion of&#xD;
      several predefined strategies mentioned by the two groups of participants to locate future&#xD;
      events in time. The investigators predict that patients will envision less personal future&#xD;
      events and will rely to a lesser extent on strategies to locate events in time, than control&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The number of subjects needed was overestimated (from assumptions made in the litterature).&#xD;
  </why_stopped>
  <start_date type="Actual">April 5, 2017</start_date>
  <completion_date type="Actual">October 20, 2019</completion_date>
  <primary_completion_date type="Actual">October 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of time location strategies</measure>
    <time_frame>1 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">56</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Patients with schizophrenia</arm_group_label>
    <description>Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control participants</arm_group_label>
    <description>- Control participants without psychiatric nor neurological history</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnary</intervention_name>
    <description>Participant's verbalization will be audio recorded and then transcribed by investigators. The investigators will use predefined categories to score the strategies mentioned by participants during the think aloud task.</description>
    <arm_group_label>Control participants</arm_group_label>
    <arm_group_label>Patients with schizophrenia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with Schizophrenia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  for patients only&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  age limits : 18-55 years old&#xD;
&#xD;
          -  under the protection of health insurance&#xD;
&#xD;
          -  who have signed up the consent form&#xD;
&#xD;
          -  schizophrenia or schizo-affective disorder according to the DSM-5 criteria (APA,&#xD;
             2013).&#xD;
&#xD;
          -  clinically stable for at least 2 months&#xD;
&#xD;
          -  patients under guardianship or curatorship need agreement of their legal&#xD;
             representative&#xD;
&#xD;
          -  informed of the results of prior medical examination for controls only&#xD;
&#xD;
          -  male or female&#xD;
&#xD;
          -  age limits : 18-55 years old&#xD;
&#xD;
          -  under the protection of health insurance&#xD;
&#xD;
          -  who have sign up the consent form&#xD;
&#xD;
          -  recruited from the general population and matched on gender, age years of schooling&#xD;
&#xD;
          -  no psychiatric history (DSM-5)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  for both patients and controls&#xD;
&#xD;
          -  current severe or unstable somatic illness&#xD;
&#xD;
          -  neurological history (brain injury &gt; 15 minutes loss of consciousness , epilepsia,&#xD;
             brain surgery…)&#xD;
&#xD;
          -  current substance use disorder (DSM-5)&#xD;
&#xD;
          -  current major depressive disorder (CDSS,BDI, HDRS)&#xD;
&#xD;
          -  mental retardation (IQ &lt; 70, WAIS-4, f-NART)&#xD;
&#xD;
          -  history of general anesthesia 3 months prior to the experiment&#xD;
&#xD;
          -  pregnancy declared by the subject&#xD;
&#xD;
          -  breast feeding&#xD;
&#xD;
          -  current legal control&#xD;
&#xD;
          -  in emergency situation&#xD;
&#xD;
          -  included during exclusion period in another experiment&#xD;
&#xD;
          -  for controls only&#xD;
&#xD;
          -  taking of antipsychotic drugs for the 3 weeks prior to inclusion&#xD;
&#xD;
          -  under guardianship or curatorship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service de psychiatrie 1</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>August 21, 2023</last_update_submitted>
  <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 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>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03040505
org study id: 6527
nct id: NCT03040505
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate temporal organization of future thinking in patients
      with schizophrenia. Patients and control participants will be asked to envision and briefly
      describe ten personal future events using a cue-words list. Then they will be asked to
      describe everything that came to their minds (i.e. to think aloud) while they attempted to
      determine when an event will likely occur. The investigators will compare the proportion of
      several predefined strategies mentioned by the two groups of participants to locate future
      events in time. The investigators predict that patients will envision less personal future
      events and will rely to a lesser extent on strategies to locate events in time, than control
      participants.
observational model: Other
time perspective: Prospective
measure: Number of time location strategies
time frame: 1 months
arm group label: Patients with schizophrenia
description: Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria
arm group label: Control participants
description: - Control participants without psychiatric nor neurological history
intervention type: Other
intervention name: questionnary
description: Participant's verbalization will be audio recorded and then transcribed by investigators. The investigators will use predefined categories to score the strategies mentioned by participants during the think aloud task.
arm group label: Control participants
arm group label: Patients with schizophrenia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No