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/NCT05965232</url>
    </required_header>
    <id_info>
      <org_study_id>2017-A01998-45</org_study_id>
      <nct_id>NCT05965232</nct_id>
    </id_info>
    <brief_title>FIbrosis and Steatosis in Patients With Psychiatric Illness</brief_title>
    <acronym>FibroPsy</acronym>
    <official_title>Screening for Severe Hepatic Fibrosis by FibroScan in a Population Presenting a Severe Psychiatric Disorder Under Treatment for at Least Two Years.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Esquirol</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Esquirol</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Background: Severe psychiatric diseases (schizophrenia, bipolarity, depression, anxious&#xD;
        syndrome) are often associated with a metabolic syndrome, including Non-Alcoholic Steato&#xD;
        Hepatitis, probably misdiagnosed in patients with psychiatric illness. Furthermore, long-term&#xD;
        exposition to substances like alcohol or to one or more psychotropic treatments may involve&#xD;
        liver detoxification role. Thanks to liver stiffness, based on FibroScan®, and CAP&#xD;
        (controlled attenuation parameter), we wanted to study prevalence of severe fibrosis and&#xD;
        steatosis in this population.&#xD;
  &#xD;
        Material &amp; Methods: Prospective study of 385 subjects hospitalised in a psychiatric hospital&#xD;
        for schizophrenia, bipolar disorder, depression or anxiety-depression disorder and receiving&#xD;
        psychotropic treatment for at least 2 years, for whom a FibroScan®, a blood test and a record&#xD;
        of clinical data were carried out, after information and informed consent.&#xD;
  &#xD;
        Benefits expected : This study should show an expected excess risk of fibrosis. FibroScan® in&#xD;
        this population and determine the risk factors more associated risk factors. Generalized or&#xD;
        targeted screening for identified risk factors in this population could help optimize in this&#xD;
        population could help optimize the choice and dosage of psychotropic of psychotropic drugs,&#xD;
        and above all, help to guide the strategy of hepatic and prevention strategy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients with psychiatric illness are often exposed to an increase risk of mortality compared&#xD;
        to the general population: a reduction of life expectancy between 7 and 24 years has been&#xD;
        described . Somatic illnesses explain 60% of this excess of mortality, particularly&#xD;
        cardiovascular diseases . Notably, patients with chronic psychiatric disorders, such as&#xD;
        depression, bipolar disorders or schizophrenia are more frequently exposed to metabolic&#xD;
        syndrome. A recent meta-analysis showed that patients with severe mental illness had a RR of&#xD;
        1.58 (1.35-1.86) of developing metabolic syndrome.&#xD;
  &#xD;
        Steatosis, or fat excess in hepatocytes defines NAFLD (non-alcoholic fatty liver disease).&#xD;
        NAFLD is a spectrum of liver illnesses associated with metabolic syndrome. Within NAFLD, NASH&#xD;
        (non-alcoholic steatohepatitis) occurs in about 5 % of the cases, liver inflammation and/or&#xD;
        fibrosis being associated to steatosis: Survival is then impaired, notably with a specific&#xD;
        risk of cirrhosis in 20% of the patients with NASH and 3 % of patients with NAFLD .&#xD;
        Hepatocarcinoma is a complication of cirrhosis but it may be observed in the absence of&#xD;
        cirrhosis in nearly 30% of the cases. Its prevalence is progressively increasing, from 20 to&#xD;
        27%. It will probably be the leading cause of liver transplantation in the next years&#xD;
        Otherwise, patients with NAFLD are also exposed to non-liver related complications:&#xD;
        cardiovascular risk is higher in this population and is the main risk of mortality.&#xD;
  &#xD;
        Although NAFLD is a frequent disease, it is yet generally misdiagnosed today, essentially&#xD;
        because of the lack of symptoms and of systematic screening. Furthermore, it is key to&#xD;
        diagnose the evolutionary stage: pure NAFLD, NASH and stage of fibrosis. The liver biopsy&#xD;
        remains the gold standard, despite its limitations linked to the sample variability and the&#xD;
        differences in interpretation even between expert pathologists.&#xD;
  &#xD;
        However, specific risks associated with this procedure, such as bleeding and even a marginal&#xD;
        risk of death have been described. Furthermore, liver biopsy is costly. All these arguments&#xD;
        explain the difficulty to apply this invasive strategy in screening in the general&#xD;
        population. That's why different methods, based on non-invasive tests, were developed to&#xD;
        diagnose fibrosis - the main prognostic factor - and more recently in a more preliminary way&#xD;
        to assess steatosis and inflammation. Two main methods are used to evaluate fibrosis stage:&#xD;
        serum biomarkers and liver stiffness. Serum biomarkers are non-parametric (for example NAFLD&#xD;
        fibrosis score, Fib4, Forns score and more recently, eLIFT.) or parametric (for example&#xD;
        FibroTest, FibroMeter.). Liver stiffness is mainly assessed by FibroScan: it is easily&#xD;
        available, and reproducible. It was largely validated in different liver diseases, including&#xD;
        NAFLD. Steatosis is simultaneously evaluated, thanks to CAP (controlled attenuation&#xD;
        parameter.). Strategies based on the associations of different markers have been evaluated to&#xD;
        increase sensibility and specificity of each method taken alone to assess fibrosis. Specific&#xD;
        combinations of elastometry and biomarkers have emerged, such as FibroMeterVCTE, and FAST.&#xD;
  &#xD;
        In the psychiatric field, NAFLD screening may be important to help to identify patients at&#xD;
        liver risk and also at a potential metabolic risk especially since a specific management is&#xD;
        available.&#xD;
  &#xD;
        Even if the association between NAFLD and psychiatric disorders has been described, its exact&#xD;
        prevalence and impact are not well identified.&#xD;
  &#xD;
        This is why we aimed to explore the prevalence of liver fibrosis and steatosis in patients&#xD;
        with chronic psychiatric illnesses. We led a prospective descriptive single-center study in&#xD;
        the Esquirol psychiatric hospital in Limoges.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 26, 2017</start_date>
    <completion_date type="Actual">July 12, 2021</completion_date>
    <primary_completion_date type="Actual">February 8, 2018</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>Severe fibrosis assessed by FibroScan® in the population of subjects with a severe psychiatric disorder who have been on psychotropic medication for more than than two years</measure>
      <time_frame>one day</time_frame>
      <description>The cut-off selected for FibroScan® ≥ 8.7 kPa is that published for the diagnosis of severe fibrosis. It is considered clinically relevant associated with a poorer prognosis.</description>
    </primary_outcome>
    <enrollment type="Actual">385</enrollment>
    <condition>Severe Bipolar I Disorder (Diagnosis)</condition>
    <condition>Bipolar I Disorder, Most Recent Episode Mixed, in Remission</condition>
    <condition>Depression Psychotic Feature</condition>
    <condition>Mood-Incongruent Delusion</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Fibroscan</intervention_name>
      <description>Performing FibroScan :&#xD;
  The patient is positioned supine, with the right arm in maximum abduction to clear the intercostal spaces.The measurement itself is performed on the right lobe of the liver via the intercostal (intersection of the mid-axillary line and the xiphoid process) using a dedicated probe (3.5 MHz) after application of a conduction gel to the skin. FibroScan® examinations are carried out by personnel trained in the use of the device.This training is specific and validated by the device's manufacturer manufacturer, EchosensTM (Paris). Ten valid measurements at the same measurement point in the right liver must be be performed, with an interquartile range/median ratio ≤ 30 (required only if the elastometry value is &gt; 7.1 KPa.</description>
      <other_name>Blood sample</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        1 dry tube to obtain serum (7 mL) and one heparinized tube for whole blood (7 mL) will be&#xD;
        collected&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects hospitalised in a psychiatric hospital for schizophrenia, bipolar disorder,&#xD;
          depression or anxiety-depression disorder and receiving psychotropic treatment for at least&#xD;
          2 years,&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients with a severe psychiatric disorder (psychotic disorder, mood disorder,&#xD;
               anxiety or anxiety disorder), and under psychotropic treatment (neuroleptic and/or&#xD;
               antidepressant) for at least two years.&#xD;
  &#xD;
          and/or antidepressant) for at least two years, and hospitalized in units treating these&#xD;
          disorders in the investigating centers.&#xD;
  &#xD;
          - Subjects or their legal representatives who have given informed consent, with social&#xD;
          insurance, aged over 18 years of age.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Short-term life-threatening conditions&#xD;
  &#xD;
            -  Liver disease already diagnosed at inclusion: cancer, cirrhosis, chronic or acute or&#xD;
               acute liver disease&#xD;
  &#xD;
            -  No antipsychotic or antidepressant treatment&#xD;
  &#xD;
            -  Anti-viral treatment demonstrating infection with hepatitis viruses or the HIV virus&#xD;
               (or known positive HIV serology)&#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>Philippe B NUBUKPO, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Centre Hospitalier Esquirol</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Centre Hospitalier Esquirol</name>
        <address>
          <city>Limoges</city>
          <zip>87025</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Centre Hospitalier Esquirol</investigator_affiliation>
      <investigator_full_name>Philippe Nubukpo</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Delusions</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/NCT05965232
  org study id: 2017-A01998-45
  nct id: NCT05965232
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Background: Severe psychiatric diseases (schizophrenia, bipolarity, depression, anxious
        syndrome) are often associated with a metabolic syndrome, including Non-Alcoholic Steato
        Hepatitis, probably misdiagnosed in patients with psychiatric illness. Furthermore, long-term
        exposition to substances like alcohol or to one or more psychotropic treatments may involve
        liver detoxification role. Thanks to liver stiffness, based on FibroScan®, and CAP
        (controlled attenuation parameter), we wanted to study prevalence of severe fibrosis and
        steatosis in this population.
  
        Material & Methods: Prospective study of 385 subjects hospitalised in a psychiatric hospital
        for schizophrenia, bipolar disorder, depression or anxiety-depression disorder and receiving
        psychotropic treatment for at least 2 years, for whom a FibroScan®, a blood test and a record
        of clinical data were carried out, after information and informed consent.
  
        Benefits expected : This study should show an expected excess risk of fibrosis. FibroScan® in
        this population and determine the risk factors more associated risk factors. Generalized or
        targeted screening for identified risk factors in this population could help optimize in this
        population could help optimize the choice and dosage of psychotropic of psychotropic drugs,
        and above all, help to guide the strategy of hepatic and prevention strategy.
  Patients with psychiatric illness are often exposed to an increase risk of mortality compared
        to the general population: a reduction of life expectancy between 7 and 24 years has been
        described . Somatic illnesses explain 60% of this excess of mortality, particularly
        cardiovascular diseases . Notably, patients with chronic psychiatric disorders, such as
        depression, bipolar disorders or schizophrenia are more frequently exposed to metabolic
        syndrome. A recent meta-analysis showed that patients with severe mental illness had a RR of
        1.58 (1.35-1.86) of developing metabolic syndrome.
  
        Steatosis, or fat excess in hepatocytes defines NAFLD (non-alcoholic fatty liver disease).
        NAFLD is a spectrum of liver illnesses associated with metabolic syndrome. Within NAFLD, NASH
        (non-alcoholic steatohepatitis) occurs in about 5 % of the cases, liver inflammation and/or
        fibrosis being associated to steatosis: Survival is then impaired, notably with a specific
        risk of cirrhosis in 20% of the patients with NASH and 3 % of patients with NAFLD .
        Hepatocarcinoma is a complication of cirrhosis but it may be observed in the absence of
        cirrhosis in nearly 30% of the cases. Its prevalence is progressively increasing, from 20 to
        27%. It will probably be the leading cause of liver transplantation in the next years
        Otherwise, patients with NAFLD are also exposed to non-liver related complications:
        cardiovascular risk is higher in this population and is the main risk of mortality.
  
        Although NAFLD is a frequent disease, it is yet generally misdiagnosed today, essentially
        because of the lack of symptoms and of systematic screening. Furthermore, it is key to
        diagnose the evolutionary stage: pure NAFLD, NASH and stage of fibrosis. The liver biopsy
        remains the gold standard, despite its limitations linked to the sample variability and the
        differences in interpretation even between expert pathologists.
  
        However, specific risks associated with this procedure, such as bleeding and even a marginal
        risk of death have been described. Furthermore, liver biopsy is costly. All these arguments
        explain the difficulty to apply this invasive strategy in screening in the general
        population. That's why different methods, based on non-invasive tests, were developed to
        diagnose fibrosis - the main prognostic factor - and more recently in a more preliminary way
        to assess steatosis and inflammation. Two main methods are used to evaluate fibrosis stage:
        serum biomarkers and liver stiffness. Serum biomarkers are non-parametric (for example NAFLD
        fibrosis score, Fib4, Forns score and more recently, eLIFT.) or parametric (for example
        FibroTest, FibroMeter.). Liver stiffness is mainly assessed by FibroScan: it is easily
        available, and reproducible. It was largely validated in different liver diseases, including
        NAFLD. Steatosis is simultaneously evaluated, thanks to CAP (controlled attenuation
        parameter.). Strategies based on the associations of different markers have been evaluated to
        increase sensibility and specificity of each method taken alone to assess fibrosis. Specific
        combinations of elastometry and biomarkers have emerged, such as FibroMeterVCTE, and FAST.
  
        In the psychiatric field, NAFLD screening may be important to help to identify patients at
        liver risk and also at a potential metabolic risk especially since a specific management is
        available.
  
        Even if the association between NAFLD and psychiatric disorders has been described, its exact
        prevalence and impact are not well identified.
  
        This is why we aimed to explore the prevalence of liver fibrosis and steatosis in patients
        with chronic psychiatric illnesses. We led a prospective descriptive single-center study in
        the Esquirol psychiatric hospital in Limoges.
  observational model: Cohort
  time perspective: Prospective
  measure: Severe fibrosis assessed by FibroScan® in the population of subjects with a severe psychiatric disorder who have been on psychotropic medication for more than than two years
  time frame: one day
  description: The cut-off selected for FibroScan® ≥ 8.7 kPa is that published for the diagnosis of severe fibrosis. It is considered clinically relevant associated with a poorer prognosis.
  intervention type: Diagnostic Test
  intervention name: Fibroscan
  description: Performing FibroScan :
  The patient is positioned supine, with the right arm in maximum abduction to clear the intercostal spaces.The measurement itself is performed on the right lobe of the liver via the intercostal (intersection of the mid-axillary line and the xiphoid process) using a dedicated probe (3.5 MHz) after application of a conduction gel to the skin. FibroScan® examinations are carried out by personnel trained in the use of the device.This training is specific and validated by the device's manufacturer manufacturer, EchosensTM (Paris). Ten valid measurements at the same measurement point in the right liver must be be performed, with an interquartile range/median ratio ≤ 30 (required only if the elastometry value is > 7.1 KPa.
  other name: Blood sample
  1 dry tube to obtain serum (7 mL) and one heparinized tube for whole blood (7 mL) will be
        collected
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Philippe B NUBUKPO, PhD
  role: Principal Investigator
  affiliation: Centre Hospitalier Esquirol
  facility: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Centre Hospitalier Esquirol
  investigator full name: Philippe Nubukpo
  investigator title: Professor
  mesh term: Delusions