<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/NCT04504474</url>
  </required_header>
  <id_info>
    <org_study_id>18-056</org_study_id>
    <nct_id>NCT04504474</nct_id>
  </id_info>
  <brief_title>Network Analysis of Adult MDD and ADHD</brief_title>
  <official_title>Network Analysis of Co-morbid Symptoms of Adult Major Depressive Disorder and Attention-deficit Hyperactivity Disorder in an Outpatient Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Health Sciences North Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Health Sciences North Research Institute</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 is an investigation to determine co-morbid symptoms between adult major depressive&#xD;
      disorder (MDD) and adult attention-deficit hyperactivity disorder (ADHD) using a novel&#xD;
      statistical technique called network analysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 21, 2018</start_date>
  <completion_date type="Anticipated">September 8, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 8, 2021</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Co-morbidity</measure>
    <time_frame>September 8, 2021</time_frame>
    <description>Characterize the ADHD/MDD symptom network in a psychiatric outpatient setting comprised of adults</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Network reliability</measure>
    <time_frame>September 8, 2021</time_frame>
    <description>Determine the stability and reliability of this network</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Central symptoms</measure>
    <time_frame>September 8, 2021</time_frame>
    <description>Determine the central symptoms that lead to co-activation of ADHD/MDD clusters</description>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>ADHD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        We will gather a recruitment of 500 male and female outpatients from the Psychiatric&#xD;
        Outpatient Clinic at Kirkwood Site attached to Health Sciences North.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants have a diagnosis of MDD or ADHD or both&#xD;
&#xD;
          -  participants are competent to consent to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kuppuswami Shivakumar, M.D.</last_name>
    <phone>705-523-7100</phone>
    <phone_ext>8234</phone_ext>
    <email>kshivakumar@hsnsudbury.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kirkwood Site - Health Sciences North</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 1X3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin Saroka, Ph.D.</last_name>
      <phone>705-523-7100</phone>
      <phone_ext>8260</phone_ext>
      <email>ksaroka@hsnsudbury.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>None of the IPD will be shared with other researchers</ipd_description>
  </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/NCT04504474
org study id: 18-056
nct id: NCT04504474
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is an investigation to determine co-morbid symptoms between adult major depressive
      disorder (MDD) and adult attention-deficit hyperactivity disorder (ADHD) using a novel
      statistical technique called network analysis.
observational model: Cohort
time perspective: Other
measure: Co-morbidity
time frame: September 8, 2021
description: Characterize the ADHD/MDD symptom network in a psychiatric outpatient setting comprised of adults
measure: Network reliability
time frame: September 8, 2021
description: Determine the stability and reliability of this network
measure: Central symptoms
time frame: September 8, 2021
description: Determine the central symptoms that lead to co-activation of ADHD/MDD clusters
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Kuppuswami Shivakumar, M.D.
phone: 705-523-7100
phone ext: 8234
email: kshivakumar@hsnsudbury.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
sharing ipd: No
ipd description: None of the IPD will be shared with other researchers