<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/NCT02209142</url>
  </required_header>
  <id_info>
    <org_study_id>2010-19</org_study_id>
    <nct_id>NCT02209142</nct_id>
  </id_info>
  <brief_title>Blood Biomarkers in Major Depression</brief_title>
  <official_title>Blood Biomarkers in Major Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression is a leading cause of disability worldwide, affecting nearly 16% of the general&#xD;
      population. Its physiopathology remains unclear. Based on gene-environment studies and&#xD;
      epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE)&#xD;
      results from the convergence of multiple factors including biological factors such as&#xD;
      multi-genic vulnerability, hormonal and immunological variations as well as environmental&#xD;
      factors. As a consequence, mRNA could define a biological signature of the MDE.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2012</start_date>
  <completion_date type="Actual">November 10, 2022</completion_date>
  <primary_completion_date type="Actual">November 10, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>describe a transcriptional signature of the Major Depressive Episode.</measure>
    <time_frame>6 months</time_frame>
    <description>The major aim of our study is to compare the expression level of selected genes between patient suffering from major depression and control subjects and within patients across the MDE evolution. We plan to describe a transcriptional signature of the MDE.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluate the role played by confounding factors as genetic polymorphisms,</measure>
    <time_frame>6 months</time_frame>
    <description>evaluate the role played by confounding factors as genetic polymorphisms to distinguish bipolar from unipolar depression</description>
  </secondary_outcome>
  <other_outcome>
    <measure>evaluate the role played by confounding factors as immune phenotype</measure>
    <time_frame>6 months</time_frame>
    <description>evaluate the role played by confounding factors as immune phenotype to distinguish bipolar from unipolar depression</description>
  </other_outcome>
  <other_outcome>
    <measure>evaluate the role played by confounding factors as psychotropic medications</measure>
    <time_frame>6 months</time_frame>
    <description>evaluate the role played by confounding factors as psychotropic medications to distinguish bipolar from unipolar depression</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">275</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>pan-genomic screen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A pan-genomic screen by blood prelevement and psychometric data collection will be set-up on a subset of MDE and control samples to identify mRNA candidates for a transcriptional signature of MDE,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood prelevement</intervention_name>
    <description>blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks</description>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>pan-genomic screen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>psychometric data collection</intervention_name>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>pan-genomic screen</arm_group_label>
    <other_name>psychometric data collection wil be done ( hamilton scale and clinical exam)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major depressive disorder at inclusion according to the DSM IV at the time of the&#xD;
             inclusion,&#xD;
&#xD;
               -  Having a score on the scale of depression of Hamilton ( HDRS-17) &gt; 19 at the time&#xD;
                  of the inclusion,&#xD;
&#xD;
               -  Taken care by a grown-up psychiatric department, that the coverage(care) is&#xD;
                  realized in ambulatory or during a hospitalization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Schizophrenia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jean Naudin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 20, 2023</last_update_submitted>
  <last_update_submitted_qc>April 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Major depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT02209142
org study id: 2010-19
nct id: NCT02209142
lead sponsor: 
has dmc: No
Depression is a leading cause of disability worldwide, affecting nearly 16% of the general
      population. Its physiopathology remains unclear. Based on gene-environment studies and
      epigenetic studies, a main hypothesis proposed that the major depressive episode (MDE)
      results from the convergence of multiple factors including biological factors such as
      multi-genic vulnerability, hormonal and immunological variations as well as environmental
      factors. As a consequence, mRNA could define a biological signature of the MDE.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: describe a transcriptional signature of the Major Depressive Episode.
time frame: 6 months
description: The major aim of our study is to compare the expression level of selected genes between patient suffering from major depression and control subjects and within patients across the MDE evolution. We plan to describe a transcriptional signature of the MDE.
measure: evaluate the role played by confounding factors as genetic polymorphisms,
time frame: 6 months
description: evaluate the role played by confounding factors as genetic polymorphisms to distinguish bipolar from unipolar depression
measure: evaluate the role played by confounding factors as immune phenotype
time frame: 6 months
description: evaluate the role played by confounding factors as immune phenotype to distinguish bipolar from unipolar depression
measure: evaluate the role played by confounding factors as psychotropic medications
time frame: 6 months
description: evaluate the role played by confounding factors as psychotropic medications to distinguish bipolar from unipolar depression
arm group label: pan-genomic screen
arm group type: Experimental
description: A pan-genomic screen by blood prelevement and psychometric data collection will be set-up on a subset of MDE and control samples to identify mRNA candidates for a transcriptional signature of MDE,
arm group label: control
arm group type: Sham Comparator
description: a pan genomic screening by blood prelevement and psychometric data collection wil be performed on healthy subject
intervention type: Other
intervention name: blood prelevement
description: blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks
arm group label: control
arm group label: pan-genomic screen
intervention type: Other
intervention name: psychometric data collection
arm group label: control
arm group label: pan-genomic screen
other name: psychometric data collection wil be done ( hamilton scale and clinical exam)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: jean Naudin, MD
role: Principal Investigator
affiliation: Assistance Publique Hopitaux De Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major