<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/NCT02983318</url>
  </required_header>
  <id_info>
    <org_study_id>100128</org_study_id>
    <nct_id>NCT02983318</nct_id>
  </id_info>
  <brief_title>Molecular Imaging of Brain Inflammation in Depressive Disorders</brief_title>
  <acronym>DiME</acronym>
  <official_title>Molecular Imaging of Brain Inflammation in Depressive Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In a number of neuropsychiatric disorders such as depression, both brain inflammation and&#xD;
      glutamate mediated excitotoxicity (cell death through over-activated stimulation) are&#xD;
      suspected to play a key role. It is difficult, if not impossible, to determine the potential&#xD;
      destructiveness of the inflammatory response seen in disease states by studying the brain's&#xD;
      inflammatory cells (microglia) activity in isolation. The investigators are proposing to&#xD;
      develop the means to concurrently study inflammatory response (i.e., microglial activity) and&#xD;
      its potentially devastating consequence (i.e., glutamate excitotoxicity) across the entire&#xD;
      brain in order to establish the importance of inflammation. In this study the investigators&#xD;
      propose a phased clinical study whereby the early-phase involves the development of our&#xD;
      capacity to study inflammation-mediated damage to brain cells, followed by a feasibility&#xD;
      study in patients with clinical depression that tests whether concurrent inflammation and&#xD;
      glutamate excess could be measured in key brain regions associated with a depressed mood&#xD;
      state.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>inflammation-related excitotoxicity in the brain</measure>
    <time_frame>single time. Data collected at baseline with no follow up.</time_frame>
    <description>Cross sectional MRI/PET scan will be used to identify inflammation related excitotoxicity in the brain in healthy individuals and those diagnosed with major depression.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Depressive Disorder, Major</condition>
  <condition>Positron-Emission Tomography</condition>
  <arm_group>
    <arm_group_label>PET/MRI using 18[F]EPPA ligand</arm_group_label>
    <description>given experimental ligand FEPPA during MRI/PET scan to identify glutamate activity in the brain using FEPPA ligand</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood drawn and analyzed&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        -  Able to pass MRI screening form (reviewed by a MRI technician)&#xD;
&#xD;
          -  diagnosed with depression or healthy control participants with no present mental&#xD;
             health disorder&#xD;
&#xD;
          -  Good general health with no diseases expected to interfere with the study&#xD;
&#xD;
          -  Subject is not pregnant, lactating, or of childbearing potential (must be practising&#xD;
             effective form of birth control)&#xD;
&#xD;
          -  Patient and healthy controls must not have an infection or an autoimmune disorder or&#xD;
             persistent inflammation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  screening form for MRI/PET is satisfactory after being reviewed by a radiologist&#xD;
&#xD;
          -  diagnosed with depression or healthy control participants with no present mental&#xD;
             health disorder&#xD;
&#xD;
          -  Good general health with no diseases expected to interfere with the study&#xD;
&#xD;
          -  Subject is not pregnant, lactating, or of childbearing potential (must be practicing&#xD;
             effective form of birth control)&#xD;
&#xD;
          -  Patient and healthy controls must not have an infection or an autoimmune disorder or&#xD;
             persistent inflammation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant systemic illness or unstable medical condition which could lead to&#xD;
             difficulty complying with the protocol&#xD;
&#xD;
          -  use of Investigational agents within last month&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lena Palaniyappan, MBBS/PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Joseph's Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2020</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>Infectious Encephalitis</mesh_term>
    <mesh_term>Encephalitis</mesh_term>
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT02983318
org study id: 100128
nct id: NCT02983318
lead sponsor: 
has dmc: No
In a number of neuropsychiatric disorders such as depression, both brain inflammation and
      glutamate mediated excitotoxicity (cell death through over-activated stimulation) are
      suspected to play a key role. It is difficult, if not impossible, to determine the potential
      destructiveness of the inflammatory response seen in disease states by studying the brain's
      inflammatory cells (microglia) activity in isolation. The investigators are proposing to
      develop the means to concurrently study inflammatory response (i.e., microglial activity) and
      its potentially devastating consequence (i.e., glutamate excitotoxicity) across the entire
      brain in order to establish the importance of inflammation. In this study the investigators
      propose a phased clinical study whereby the early-phase involves the development of our
      capacity to study inflammation-mediated damage to brain cells, followed by a feasibility
      study in patients with clinical depression that tests whether concurrent inflammation and
      glutamate excess could be measured in key brain regions associated with a depressed mood
      state.
observational model: Other
time perspective: Cross-Sectional
measure: inflammation-related excitotoxicity in the brain
time frame: single time. Data collected at baseline with no follow up.
description: Cross sectional MRI/PET scan will be used to identify inflammation related excitotoxicity in the brain in healthy individuals and those diagnosed with major depression.
arm group label: PET/MRI using 18[F]EPPA ligand
description: given experimental ligand FEPPA during MRI/PET scan to identify glutamate activity in the brain using FEPPA ligand
Blood drawn and analyzed
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: 105 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lena Palaniyappan, MBBS/PhD
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Infectious Encephalitis
mesh term: Encephalitis
mesh term: Inflammation
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
sharing ipd: No