<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/NCT04483661</url>
  </required_header>
  <id_info>
    <org_study_id>B-ER-108-058</org_study_id>
    <nct_id>NCT04483661</nct_id>
  </id_info>
  <brief_title>Development of Systems and Precision Medicine - Take Mood Disorder as an Example.</brief_title>
  <official_title>Development of Systems and Precision Medicine - Take Mood Disorder as an Example.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</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>
      Precision medicine is to achieve individual optimal health care, given the biological&#xD;
      mechanisms, genetic variants, and environmental measurements. Take mood disorder (MD) as an&#xD;
      example, we aim to develop systems and precision medicine in Taiwanese population.&#xD;
&#xD;
      MD is a very serious and dysfunctional mental disorder. Since MD patients with treatment have&#xD;
      high risk of neurocognitive impairment and metabolic disturbances, the therapeutic strategies&#xD;
      are of clinical importance. Individual difference of treatment outcome in MD patients would&#xD;
      result from genetic variants, environmental factors, and their interactions. Also, the&#xD;
      treatment outcome of MD contains multiple dimensions, including improvement of disease&#xD;
      severity, neurocognitive function, and optimized medication strategy. However, comprehensive&#xD;
      development of approaches to investigate the multiple dimensions of treatment outcome in MD&#xD;
      patients is limited. In this three-year proposal, we explore the interactions of genetic&#xD;
      variants and environmental factors (represented by psychosocial stress and gut microbiota)&#xD;
      driven approaches to develop precision medicine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 27, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Depression severity</measure>
    <time_frame>six months</time_frame>
    <description>Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale (17-item)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The influence of environmental factor in mood disorder</measure>
    <time_frame>six months</time_frame>
    <description>Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cognitive function assessed using the Finger Tapping Test (FTT)</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cognitive function assessed using Wisconsin Card Sorting Test (WCST)</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cognitive function assessed using Continuous Performance Test (CPT)</measure>
    <time_frame>six months</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Mood Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who met the criteria will be successively recruited from the National Cheng Kung&#xD;
        University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients, 20- 70 years of age&#xD;
&#xD;
          -  Major depression disorder who met the DSM-V diagnostic criteria were enrolled&#xD;
&#xD;
          -  Subjects take at least one kind of antidepressant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding&#xD;
&#xD;
          -  Presence of any other major psychiatric illness&#xD;
&#xD;
          -  History of substance and alcohol abuse or dependence&#xD;
&#xD;
          -  Presence of auto-immune disorder and infectious diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Cheng Kung University (NCKU) Hospital</name>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui Hua Chang, PhD</last_name>
      <phone>886-2353535</phone>
      <phone_ext>5683</phone_ext>
      <email>huihua@mail.ncku.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mood disorder, neurocognitive function, metabolic disturbances, microbiota-gut-brain axis, genetic variant, pharmacogenomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mood Disorders</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/NCT04483661
org study id: B-ER-108-058
nct id: NCT04483661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Precision medicine is to achieve individual optimal health care, given the biological
      mechanisms, genetic variants, and environmental measurements. Take mood disorder (MD) as an
      example, we aim to develop systems and precision medicine in Taiwanese population.

      MD is a very serious and dysfunctional mental disorder. Since MD patients with treatment have
      high risk of neurocognitive impairment and metabolic disturbances, the therapeutic strategies
      are of clinical importance. Individual difference of treatment outcome in MD patients would
      result from genetic variants, environmental factors, and their interactions. Also, the
      treatment outcome of MD contains multiple dimensions, including improvement of disease
      severity, neurocognitive function, and optimized medication strategy. However, comprehensive
      development of approaches to investigate the multiple dimensions of treatment outcome in MD
      patients is limited. In this three-year proposal, we explore the interactions of genetic
      variants and environmental factors (represented by psychosocial stress and gut microbiota)
      driven approaches to develop precision medicine.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Depression severity
time frame: six months
description: Clinician rated score by Structure Interview Guide for the Hamilton Depression Rating Scale (17-item)
measure: The influence of environmental factor in mood disorder
time frame: six months
description: Collect the DNA of fecal flora to test the diversity and abundance of gut microbiota
measure: cognitive function assessed using the Finger Tapping Test (FTT)
time frame: six months
measure: cognitive function assessed using Wisconsin Card Sorting Test (WCST)
time frame: six months
measure: cognitive function assessed using Continuous Performance Test (CPT)
time frame: six months
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Mood Disorders