<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/NCT03227133</url>
  </required_header>
  <id_info>
    <org_study_id>P/2016/297</org_study_id>
    <nct_id>NCT03227133</nct_id>
  </id_info>
  <brief_title>Oral Fluency and the Response to Antidepressant Therapy in the Elderly With a Unipolar Depressive Episode</brief_title>
  <acronym>PREDICTage</acronym>
  <official_title>An Exploratory Study of the Use of Oral Fluency as a Predictive Tool for the Antidepressant Response of Elderly With Unipolar Depressive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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 study focuses on the identification of clinical, physiological and morphological markers&#xD;
      that could predict the response to antidepressant in elderly suffering from unipolar&#xD;
      depressive disorder.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 23, 2016</start_date>
  <completion_date type="Anticipated">June 23, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ability of the verbal fluency test score to predict the response to antidepressive treatment</measure>
    <time_frame>week 10</time_frame>
    <description>verbal fluency is assessed during the neuropsychological assessment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Unipolar Depression</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neuropsychological evaluations</intervention_name>
    <description>Neuropsychological evaluations including oral fluency, performed specifically for the study</description>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychiatric interview</intervention_name>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cardiovascular risk assessment</intervention_name>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Depressive episode according to DSM-5 criteria&#xD;
&#xD;
          -  Unipolar depression&#xD;
&#xD;
          -  MADRS ≥ 20&#xD;
&#xD;
          -  Antidepressive treatment (Serotonin Reuptake Inhibitors/Serotonin Norepinephrine&#xD;
             Reuptake Inhibitors)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other comorbid mental disorders (bipolar disorder, schizophrenia, recent addiction &lt; 3&#xD;
             months except for tobacco)&#xD;
&#xD;
          -  Depression with psychotic features&#xD;
&#xD;
          -  Serious unstabilized somatic illness&#xD;
&#xD;
          -  Protected persons&#xD;
&#xD;
          -  Dementia suspected at the time of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Masse-Sibille, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire de Besançon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Julie Monnin, PhD</last_name>
    <email>jmonnin@chu-besancon.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Besançon</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julie Monnin, PhD</last_name>
      <email>jmonnin@chu-besancon.fr</email>
    </contact>
    <investigator>
      <last_name>Caroline Masse-Sibille, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emmanuel Haffen, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nazim Nekrouf, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre Vandel, MS, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</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>Depressive Disorder</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/NCT03227133
org study id: P/2016/297
nct id: NCT03227133
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study focuses on the identification of clinical, physiological and morphological markers
      that could predict the response to antidepressant in elderly suffering from unipolar
      depressive disorder.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Ability of the verbal fluency test score to predict the response to antidepressive treatment
time frame: week 10
description: verbal fluency is assessed during the neuropsychological assessment
arm group label: Single arm
arm group type: Experimental
description: Psychiatric interview, Neuropsychological evaluations, cardiovascular risk assessment
intervention type: Other
intervention name: Neuropsychological evaluations
description: Neuropsychological evaluations including oral fluency, performed specifically for the study
arm group label: Single arm
intervention type: Other
intervention name: Psychiatric interview
arm group label: Single arm
intervention type: Other
intervention name: Cardiovascular risk assessment
arm group label: Single arm
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline Masse-Sibille, MD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire de Besançon
last name: Julie Monnin, PhD
email: jmonnin@chu-besancon.fr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Depressive Disorder
sharing ipd: No