<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/NCT04486092</url>
  </required_header>
  <id_info>
    <org_study_id>A-ER-104-031</org_study_id>
    <nct_id>NCT04486092</nct_id>
  </id_info>
  <brief_title>Mood Stabilizer-induced Metabolic Abnormalities in Bipolar Disorder</brief_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>
  <brief_summary>
    <textblock>
      The potential effects of microbiota in bipolar disorder (BD) with microbiota-related&#xD;
      dysfunction have not yet been explored clinically, and the integration of microbiota and&#xD;
      pharmacometabolomic approaches can provide us the identification of the significant effects&#xD;
      of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance.&#xD;
      Therefore, we propose to develop the integration of the microbiota and pharmacometabolomics&#xD;
      knowledge base about the mood stabilizer-induced metabolic abnormalities in BD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gut microbiota composition</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Metabolic syndrome</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Valproic Acid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valproic Acid</intervention_name>
    <arm_group_label>Valproic Acid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bipolar disorder outpatients (aged 18-65 years) who meet the Diagnostic and&#xD;
             Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnostic criteria and&#xD;
             start to receive valproate (VPA) will be enrolled consecutively by trained&#xD;
             psychiatrists.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclude are patients who had DSM-V diagnosis for substance abuse within the past three&#xD;
             months&#xD;
&#xD;
          -  Had treated with antibiotics and/or functional foods (probiotics and/or prebiotics)&#xD;
             for at least one month before entering study&#xD;
&#xD;
          -  Presence of stomach/gut problems such as chronic diarrhea, constipation, gas,&#xD;
             heartburn, bloating, etc.&#xD;
&#xD;
          -  Had an organic mental disorder, mental retardation, dementia, or other diagnosed&#xD;
             neurological illness&#xD;
&#xD;
          -  Had a surgical condition or a major physical illness&#xD;
&#xD;
          -  Were pregnant or breast-feeding&#xD;
&#xD;
          -  Had any concomitant DSM-V Axis I diagnoses together with somatic or neurologic&#xD;
             illnesses interfering psychiatric evaluation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hui-Hua Chang, Ph.D.</last_name>
    <phone>886-6-2353535</phone>
    <phone_ext>5683</phone_ext>
    <email>huihua@mail.ncku.edu.tw</email>
  </overall_contact>
  <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>January 2020</verification_date>
  <study_first_submitted>October 11, 2015</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 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>Bipolar Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valproic Acid</mesh_term>
  </intervention_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/NCT04486092
org study id: A-ER-104-031
nct id: NCT04486092
lead sponsor: 
The potential effects of microbiota in bipolar disorder (BD) with microbiota-related
      dysfunction have not yet been explored clinically, and the integration of microbiota and
      pharmacometabolomic approaches can provide us the identification of the significant effects
      of mood stabilizers on metabolic homeostasis, treatment response, and cognitive performance.
      Therefore, we propose to develop the integration of the microbiota and pharmacometabolomics
      knowledge base about the mood stabilizer-induced metabolic abnormalities in BD patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Gut microbiota composition
time frame: 12 weeks
measure: Metabolic syndrome
time frame: 12 weeks
arm group label: Valproic Acid
arm group type: Experimental
intervention type: Drug
intervention name: Valproic Acid
arm group label: Valproic Acid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hui-Hua Chang, Ph.D.
phone: 886-6-2353535
phone ext: 5683
email: huihua@mail.ncku.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Bipolar Disorder
mesh term: Valproic Acid