<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/NCT01689181</url>
  </required_header>
  <id_info>
    <org_study_id>C11-39</org_study_id>
    <secondary_id>2011-A01610-41</secondary_id>
    <nct_id>NCT01689181</nct_id>
  </id_info>
  <brief_title>Apathy in Schizophrenia</brief_title>
  <official_title>L'Apathie Dans la schizophrénie: étude Neuropsychologique et Anatomique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut National de la Santé Et de la Recherche Médicale, France</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is&#xD;
      a core component of negative symptoms. It has been suggested that the physiopathology of&#xD;
      apathy is not a single entity but may be multiple, depending on which specific process or&#xD;
      macrofunction is disrupted during completion of GDB. In line with this notion, Levy and&#xD;
      Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing:&#xD;
      'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been&#xD;
      associated with executive dysfunction, functional impairment and poor outcome. However, the&#xD;
      neurobiological underpinnings of apathy in schizophrenia are poorly understood.&#xD;
&#xD;
      Primary objective: confirm that chronic schizophrenic patients are apathic compared to&#xD;
      healthy volunteers&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  investigate if apathy is related to a particular aspect of the disease (i.e. negative,&#xD;
           positive symptomatology and/or deficit form)&#xD;
&#xD;
        -  investigate if apathy correlates with executive dysfunction&#xD;
&#xD;
        -  investigate if apathy is associated with a specific mechanism using an experimental task&#xD;
           specially designed to investigate the different mechanism (i.e. 'a-motivation',&#xD;
           'cognitive inertia', and 'uncoupling')&#xD;
&#xD;
        -  investigate if there is a volumetric abnormality affecting the executive system in&#xD;
           apathic schizophrenic patients&#xD;
&#xD;
        -  link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits&#xD;
           according to a specific subtype of apathy in the apathic schizophrenic group&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>apathy as measured by Starkstein's Apathy Evaluation Scale</measure>
    <time_frame>baseline</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>neuropsychological performance</measure>
    <time_frame>baseline</time_frame>
    <description>Global mental efficience: Mill Hill B and Raven's progressive matrices 38&#xD;
Executive functioning:Modified Card Sorting Test, Trail Making A and B, Stroop Test, Verbal Fluences, Frontal Assessment Battery (FAB, Dubois et al., 2000)&#xD;
Social and Emotional Cognition: SEA (Social and Emotional Evaluation (SEA, Funkiewiez et al., 2012)&#xD;
Working memory (Grober and Buschke - 16 items, digit span)&#xD;
Instrumental functions: Rey Osterrieth Complex figure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical assessment (for patients only)</measure>
    <time_frame>baseline</time_frame>
    <description>scores on evaluation scales (PANSS, SAPS, SANS, CDS, SDS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>volumetric brain abnormalities</measure>
    <time_frame>baseline</time_frame>
    <description>voxel based morphometry</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Apathy</condition>
  <arm_group>
    <arm_group_label>chronic schizophrenic patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy volunteers</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        schizophrenic patients:&#xD;
&#xD;
          -  outpatients of the Corentin Celton psychiatric service&#xD;
&#xD;
          -  inpatients of the Corentin Celton Day Hospital Unit&#xD;
&#xD;
        healthy volunteers: community&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (healthy volunteers):&#xD;
&#xD;
          -  Male or Female aged 20 to 55 years old included&#xD;
&#xD;
          -  Under French public assurance system&#xD;
&#xD;
        Exclusion Criteria (healthy volunteers):&#xD;
&#xD;
          -  Personal history of neurological disorders&#xD;
&#xD;
          -  Personal history of head injury&#xD;
&#xD;
          -  Alcohol or substance abuse&#xD;
&#xD;
          -  Under psychotropic drug&#xD;
&#xD;
          -  Contraindication for MRI&#xD;
&#xD;
        Inclusion Criteria (schizophrenic patients):&#xD;
&#xD;
          -  Male or Female aged 20 to 55 years old included&#xD;
&#xD;
          -  Under French public assurance system&#xD;
&#xD;
          -  diagnosis of schizophrenia according to the DSM-IV R criteria&#xD;
&#xD;
          -  Duration of illness &gt; 5 years&#xD;
&#xD;
          -  clinical stability during the past 2 months (defined as no treatment modification or&#xD;
             hospitalisation 2 months prior evaluation)&#xD;
&#xD;
        Exclusion Criteria (schizophrenic patients):&#xD;
&#xD;
          -  Schizo-affective disorder&#xD;
&#xD;
          -  Personal history of neurological disorders&#xD;
&#xD;
          -  Personal history of head injury&#xD;
&#xD;
          -  Alcohol or substance abuse&#xD;
&#xD;
          -  Contraindication for MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Levy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière, 75013 Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard LEVY, MD/PHD</last_name>
    <phone>00.33.1.49.28.24.32</phone>
    <email>richard.levy@sat.aphp.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 17, 2012</last_update_submitted>
  <last_update_submitted_qc>September 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2012</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>
  <!-- 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/NCT01689181
org study id: C11-39
secondary id: 2011-A01610-41
nct id: NCT01689181
lead sponsor: 
has dmc: No
Apathy, defined as a quantitative reduction of voluntary, goal-directed behaviours (GDB), is
      a core component of negative symptoms. It has been suggested that the physiopathology of
      apathy is not a single entity but may be multiple, depending on which specific process or
      macrofunction is disrupted during completion of GDB. In line with this notion, Levy and
      Dubois proposed dividing apathic syndromes into three subtypes of disrupted processing:
      'a-motivation', 'cognitive inertia', and 'uncoupling'. In schizophrenia, apathy has been
      associated with executive dysfunction, functional impairment and poor outcome. However, the
      neurobiological underpinnings of apathy in schizophrenia are poorly understood.

      Primary objective: confirm that chronic schizophrenic patients are apathic compared to
      healthy volunteers

      Secondary objectives:

        -  investigate if apathy is related to a particular aspect of the disease (i.e. negative,
           positive symptomatology and/or deficit form)

        -  investigate if apathy correlates with executive dysfunction

        -  investigate if apathy is associated with a specific mechanism using an experimental task
           specially designed to investigate the different mechanism (i.e. 'a-motivation',
           'cognitive inertia', and 'uncoupling')

        -  investigate if there is a volumetric abnormality affecting the executive system in
           apathic schizophrenic patients

        -  link these eventual volumetric abnormalities to prefrontal cortex-basal ganglia circuits
           according to a specific subtype of apathy in the apathic schizophrenic group
observational model: Case-Control
time perspective: Cross-Sectional
measure: apathy as measured by Starkstein's Apathy Evaluation Scale
time frame: baseline
measure: neuropsychological performance
time frame: baseline
description: Global mental efficience: Mill Hill B and Raven's progressive matrices 38
Executive functioning:Modified Card Sorting Test, Trail Making A and B, Stroop Test, Verbal Fluences, Frontal Assessment Battery (FAB, Dubois et al., 2000)
Social and Emotional Cognition: SEA (Social and Emotional Evaluation (SEA, Funkiewiez et al., 2012)
Working memory (Grober and Buschke - 16 items, digit span)
Instrumental functions: Rey Osterrieth Complex figure)
measure: clinical assessment (for patients only)
time frame: baseline
description: scores on evaluation scales (PANSS, SAPS, SANS, CDS, SDS)
measure: volumetric brain abnormalities
time frame: baseline
description: voxel based morphometry
arm group label: chronic schizophrenic patients
arm group label: healthy volunteers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Levy, MD
role: Principal Investigator
affiliation: INSERM MEDU 945, Centre de Recherche-Institut du Cerveau et de la Moelle (CR-ICM), Hôpital de la Pitié Salpétrière, 75013 Paris
last name: Richard LEVY, MD/PHD
phone: 00.33.1.49.28.24.32
email: richard.levy@sat.aphp.fr
facility: 
status: Recruiting
country: France
responsible party type: Sponsor
mesh term: Schizophrenia