xml: <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/NCT05966610</url>
    </required_header>
    <id_info>
      <org_study_id>RC31/22/0517</org_study_id>
      <secondary_id>2023-A00049-36</secondary_id>
      <nct_id>NCT05966610</nct_id>
    </id_info>
    <brief_title>Bizarreness and Anomalous Self Experiences in Schizophrenia</brief_title>
    <acronym>BASES</acronym>
    <official_title>Bizarreness and Anomalous Self Experiences in Schizophrenia: Pilot Study on Diagnostic Decision-Making</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Toulouse</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Toulouse</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>
        Several authors suggest that the specific experience felt in clinical encounter, called&#xD;
        Praecox Feeling, is directly linked to the psychopathology of Schizophrenia.&#xD;
  &#xD;
        However, determining factors of this phenomena, whether cognitive or subjective, remains&#xD;
        poorly studied.&#xD;
  &#xD;
        Furthermore, Self-Disorders are alterations of the first-person experience regarded as&#xD;
        specific of the disease. The investigators plan to study in an exploratory way the&#xD;
        phenomenological and subjective links between Praecox Feeling and Self Disorders&#xD;
        determinants, while hypothesizing that the clinician's Praecox Feeling can be positively&#xD;
        correlated to SDs, as our main objective.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Several authors suggest that the specific experience felt in clinical encounter, called&#xD;
        Praecox Feeling, is directly linked to the psychopathology of Schizophrenia. However,&#xD;
        subjective, cognitive or neurophysiologic aspects of this phenomena remains poorly studied.&#xD;
  &#xD;
        Furthermore, Self-Disorders (SD) are alterations of the first-person experience and of sense&#xD;
        of agency, regarded as specific of Schizophrenia. Unlike Praecox Feeling, clinical, cognitive&#xD;
        and neuropsychological determinants of SD are increasingly studied.&#xD;
  &#xD;
        The investigators plan to study in an exploratory way the links between Praecox Feeling and&#xD;
        SDs determinants, while hypothesizing that the clinician's Praecox Feeling can be positively&#xD;
        correlated to SDs, as our main objective.&#xD;
  &#xD;
        As a secondary outcome, the investigators will control this correlation by a comparison&#xD;
        between SDs evaluation and clinician subjectivity.&#xD;
  &#xD;
        The present study also plan to evaluate the associations between Praecox Feeling and clinical&#xD;
        features, low and high cognitive level with attentional and social cognition evaluations.&#xD;
  &#xD;
        The first step of the research project is to implement this exploratory design in a&#xD;
        transversal multicentric setting between centers with a limited number of participants and&#xD;
        without follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 12, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 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>Correlation between Praecox Feeling and Self Disorders</measure>
      <time_frame>2 months</time_frame>
      <description>Comparison between Examination of Anomalous Subjective Experience (EASE) total score evaluated at third visit and mean of Praecox Feeling intensity measured by a visual analog scale (VAS) evaluated at each visit.&#xD;
  Examination of Anomalous Subjective Experience is a 5-item interview asked by the investigator.&#xD;
  Visual Analog Scale (VAS) is a scale that evaluates the level of strangeness felt during the patient/investigator encounter. It goes from 0 (no strangeness feeling) to 100 (maximal strangeness feeling).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation between Praecox Feeling and symptomatic dimensions</measure>
      <time_frame>2 months</time_frame>
      <description>Comparison between mean of Praecox Feeling intensity measured by a visual analog scale evaluated at each visit and Cognition evaluation in second visit with attentional evaluation (D2-R and results at Go/No-Go testing) and social cognition evaluation (TOM-15).&#xD;
  D2-R is a paper-and-pencil test. It's consists of the subject identifying and crossing out target characters (d with 2 lines) from a large number of characters.&#xD;
  Go/No-Go testing is a test assesses behavioural control in a test where the participant must be able to respond to an automated external stimulus.&#xD;
  TOM-15 consists of a false belief task and a comprehension task using the same 15 stories but different questions. The stories proposed show everyday situations. There are 8 first-order questions and 7 second-order questions, allowing two scores to be calculated, one for each order (maximum 15 in total). The more correct answers, the higher the score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between Praecox Feeling intensity and Self Disorders intensity</measure>
      <time_frame>2 months</time_frame>
      <description>Comparison between Examination of Anomalous Subjective Experience (EASE) total score a the third visit and mean of clinician subjectivity measured by Assessment of clinician's subjective experience (ACSE) at each visit.&#xD;
  Examination of Anomalous Subjective Experience is a scale completed during the clinical interview by the investigator. It consists a 5-item scale.&#xD;
  Assessment of clinician's subjective experience is a scale completed during the clinical interview by the investigator. It is composed of 45 items.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between the patient's judgment and the quality of the meeting</measure>
      <time_frame>2 months</time_frame>
      <description>Meeting Quality, according to the participant, evaluated at second visit in an unstructured way.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Schizophrenia</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Stabilised patients with schizophrenia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People with a diagnosis of schizophrenia according to the Diagnostic and Statistical&#xD;
               Manual of Mental Disorders (DSM-V) criteria.&#xD;
  &#xD;
            -  Psychiatric medical situation judged clinically stable : no change of main&#xD;
               antipsychotic in treatment in last 15 days.&#xD;
  &#xD;
            -  People who has given his non-opposition&#xD;
  &#xD;
            -  Patients affiliated to a social security system&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous meeting of the participant with one of the investigators involved in the&#xD;
               clinical assessment and scoring of the study scales.&#xD;
  &#xD;
            -  Person with a moderate to severe intellectual disability (clinical criteria).&#xD;
  &#xD;
            -  Person with a neurological pathology with cognitive impact&#xD;
  &#xD;
            -  Patients with legal protection&#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>Tudi GOZE, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Toulouse</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Tudi GOZE, MD</last_name>
      <phone>5 61 77 23 60</phone>
      <phone_ext>+33</phone_ext>
      <email>goze.t@chu-toulouse.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>CHU Toulouse</name>
        <address>
          <city>Toulouse</city>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Tudi GOZE, PH</last_name>
        <phone>05 61 77 23 60</phone>
        <phone_ext>+33</phone_ext>
        <email>goze.t@chu-toulouse.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>May 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Praecox Feeling</keyword>
    <keyword>Self-Disorders</keyword>
    <keyword>Subjectivity</keyword>
    <keyword>Cognition</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>
  
  
text: 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/NCT05966610
  org study id: RC31/22/0517
  secondary id: 2023-A00049-36
  nct id: NCT05966610
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Several authors suggest that the specific experience felt in clinical encounter, called
        Praecox Feeling, is directly linked to the psychopathology of Schizophrenia.
  
        However, determining factors of this phenomena, whether cognitive or subjective, remains
        poorly studied.
  
        Furthermore, Self-Disorders are alterations of the first-person experience regarded as
        specific of the disease. The investigators plan to study in an exploratory way the
        phenomenological and subjective links between Praecox Feeling and Self Disorders
        determinants, while hypothesizing that the clinician's Praecox Feeling can be positively
        correlated to SDs, as our main objective.
  Several authors suggest that the specific experience felt in clinical encounter, called
        Praecox Feeling, is directly linked to the psychopathology of Schizophrenia. However,
        subjective, cognitive or neurophysiologic aspects of this phenomena remains poorly studied.
  
        Furthermore, Self-Disorders (SD) are alterations of the first-person experience and of sense
        of agency, regarded as specific of Schizophrenia. Unlike Praecox Feeling, clinical, cognitive
        and neuropsychological determinants of SD are increasingly studied.
  
        The investigators plan to study in an exploratory way the links between Praecox Feeling and
        SDs determinants, while hypothesizing that the clinician's Praecox Feeling can be positively
        correlated to SDs, as our main objective.
  
        As a secondary outcome, the investigators will control this correlation by a comparison
        between SDs evaluation and clinician subjectivity.
  
        The present study also plan to evaluate the associations between Praecox Feeling and clinical
        features, low and high cognitive level with attentional and social cognition evaluations.
  
        The first step of the research project is to implement this exploratory design in a
        transversal multicentric setting between centers with a limited number of participants and
        without follow-up.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation between Praecox Feeling and Self Disorders
  time frame: 2 months
  description: Comparison between Examination of Anomalous Subjective Experience (EASE) total score evaluated at third visit and mean of Praecox Feeling intensity measured by a visual analog scale (VAS) evaluated at each visit.
  Examination of Anomalous Subjective Experience is a 5-item interview asked by the investigator.
  Visual Analog Scale (VAS) is a scale that evaluates the level of strangeness felt during the patient/investigator encounter. It goes from 0 (no strangeness feeling) to 100 (maximal strangeness feeling).
  measure: Correlation between Praecox Feeling and symptomatic dimensions
  time frame: 2 months
  description: Comparison between mean of Praecox Feeling intensity measured by a visual analog scale evaluated at each visit and Cognition evaluation in second visit with attentional evaluation (D2-R and results at Go/No-Go testing) and social cognition evaluation (TOM-15).
  D2-R is a paper-and-pencil test. It's consists of the subject identifying and crossing out target characters (d with 2 lines) from a large number of characters.
  Go/No-Go testing is a test assesses behavioural control in a test where the participant must be able to respond to an automated external stimulus.
  TOM-15 consists of a false belief task and a comprehension task using the same 15 stories but different questions. The stories proposed show everyday situations. There are 8 first-order questions and 7 second-order questions, allowing two scores to be calculated, one for each order (maximum 15 in total). The more correct answers, the higher the score
  measure: Correlation between Praecox Feeling intensity and Self Disorders intensity
  time frame: 2 months
  description: Comparison between Examination of Anomalous Subjective Experience (EASE) total score a the third visit and mean of clinician subjectivity measured by Assessment of clinician's subjective experience (ACSE) at each visit.
  Examination of Anomalous Subjective Experience is a scale completed during the clinical interview by the investigator. It consists a 5-item scale.
  Assessment of clinician's subjective experience is a scale completed during the clinical interview by the investigator. It is composed of 45 items.
  measure: Correlation between the patient's judgment and the quality of the meeting
  time frame: 2 months
  description: Meeting Quality, according to the participant, evaluated at second visit in an unstructured way.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Tudi GOZE, MD
  role: Principal Investigator
  affiliation: University Hospital, Toulouse
  last name: Tudi GOZE, MD
  phone: 5 61 77 23 60
  phone ext: +33
  email: goze.t@chu-toulouse.fr
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Schizophrenia