<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/NCT02202460</url>
  </required_header>
  <id_info>
    <org_study_id>rrw2014</org_study_id>
    <secondary_id>IFMISMD</secondary_id>
    <nct_id>NCT02202460</nct_id>
  </id_info>
  <brief_title>The Potential Biomark of Serious Psychosis:a Prospective,Case-controled Study</brief_title>
  <official_title>The Potential Biomark of Serious Psychosis: Including the Variation of Brain MRI, BDNF and Oxidative Stress-related Immunological Factors in Different Phases.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central South University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and&#xD;
      MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients suffer from Schizophrenia and Mood Disorders may have variation in immunological&#xD;
      factors(TNF-α,IL-2,IL-6,IL-10,etc),BDNF and Brain MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>18 Months</target_duration>
  <primary_outcome>
    <measure>Oxidative Stress-related Immunological Factors</measure>
    <time_frame>18 month</time_frame>
    <description>Blood test will be conducted every 3 month to assess the concentration of oxidative stress-related immunological factors including TNFα,TGFβ， MCP-1，IL-1α，IL-2，IL-6，IL-10，IL-12.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BDNF</measure>
    <time_frame>18 month</time_frame>
    <description>Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Brain MRI</measure>
    <time_frame>18 month</time_frame>
    <description>Brain MRI will be examined every 6 month or when onset syptoms are dramatically changed.</description>
  </other_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Other Immunological States or Disorders</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Schizophrenia , Bipolar Disorder , Major Depression&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis with Schizophrenia , Bipolar Disorder or Major Depression by DSM-5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable physical conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Renrong Wu, PhD</last_name>
    <phone>+86 15874179855</phone>
    <email>wurenrong2013@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mental Health Institute of 2nd Xiangya Hospital,CSU</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Renrong Wu, PhD</last_name>
      <phone>15874179855</phone>
      <email>wurenrong2013@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central South University</investigator_affiliation>
    <investigator_full_name>Renrong Wu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic 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/NCT02202460
org study id: rrw2014
secondary id: IFMISMD
nct id: NCT02202460
lead sponsor: 
has dmc: Yes
Patients suffer from Serious Psychosis may have variation in immunological factors,BDNF and
      MRI.
Patients suffer from Schizophrenia and Mood Disorders may have variation in immunological
      factors(TNF-α,IL-2,IL-6,IL-10,etc),BDNF and Brain MRI.
observational model: Case-Control
time perspective: Prospective
measure: Oxidative Stress-related Immunological Factors
time frame: 18 month
description: Blood test will be conducted every 3 month to assess the concentration of oxidative stress-related immunological factors including TNFα,TGFβ， MCP-1，IL-1α，IL-2，IL-6，IL-10，IL-12.
measure: BDNF
time frame: 18 month
description: Collecting participants' blood every 3 month to assess the concentration of brain derived neurotrophic factor.
measure: Brain MRI
time frame: 18 month
description: Brain MRI will be examined every 6 month or when onset syptoms are dramatically changed.
blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Renrong Wu, PhD
phone: +86 15874179855
email: wurenrong2013@163.com
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Central South University
investigator full name: Renrong Wu
investigator title: Professor
mesh term: Psychotic Disorders