<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/NCT03007303</url>
  </required_header>
  <id_info>
    <org_study_id>GFu01</org_study_id>
    <nct_id>NCT03007303</nct_id>
  </id_info>
  <brief_title>The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalian Seventh People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dalian Seventh People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the relationship of circulating microRNA-30e and schizophrenia, and&#xD;
      shows the relevance of the aberrant microRNA-30e expression in plasma with the variation&#xD;
      disease status.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The plasma samples from 15 individuals with schizophrenia (with a diagnosis of ICD-10) and&#xD;
      the equivalent healthy controls will be conducted with the quantification analysis of the&#xD;
      microRNA-30e via real-time quantitative polymerase chain reaction(RT-PCR).&#xD;
&#xD;
      The 15 patients enrolled should be the first-episode and have not been treated, or were drug&#xD;
      free 3 months recently at least.&#xD;
&#xD;
      This research measures the expression level of microRNA-30e in schizophrenia respectively&#xD;
      before the beginning treatment with atypical psychotics or combined with MECT, after the&#xD;
      4-week treated , the 8-week treated compared with 15 healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2016</start_date>
  <completion_date type="Anticipated">July 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</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>8 Weeks</target_duration>
  <primary_outcome>
    <measure>the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)</measure>
    <time_frame>before the treatment</time_frame>
    <description>the plasma samples will be collected from the patients with schizophrenia and the healthy controls at the beginning recruit for the microRNA-30e detection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)</measure>
    <time_frame>Change from Baseline expression level at 4-week treatment</time_frame>
    <description>the plasma samples will be collected from the patients with schizophrenia at the 4-week treatment for the microRNA-30e detection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)</measure>
    <time_frame>Change from Baseline expression level at 8-week treatment</time_frame>
    <description>the plasma samples will be collected from the patients with schizophrenia at the 8-week treatment for the microRNA-30e detection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia</measure>
    <time_frame>before, after 4 weeks and 8 weeks treatment</time_frame>
    <description>The PANSS for estimating the severity of positive and negative symptoms in schizophrenia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia</measure>
    <time_frame>before, after 4 weeks and 8 weeks treatment</time_frame>
    <description>The degree of Personal and Social Performance scale(PSP) used to evaluate the disable levels in Multiple dimensions ,especially in social and self-care performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment</measure>
    <time_frame>4 weeks and 8 weeks treatment</time_frame>
    <description>Main purpose to provide a global rating of illness severity ,improvement and response to treatment for the patients with schizophrenia</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Micrognathia</condition>
  <arm_group>
    <arm_group_label>schizophrenia</arm_group_label>
    <description>15 patients with schizophrenia will be treated with anyone of the atypical psychotics(including olanzapine, quetiapine , ziprasidone and risperidone)or combined with MECT.&#xD;
The fluctuating dosage depends on the changes of symptom according to the total scores of Positive and Negative Syndrome Scale from schizophrenia patients after treated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>health controls</arm_group_label>
    <description>15 healthy individuals were collected from Dalian seventh people's hospital and were matched on age and sex to schizophrenia group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atypical Antipsychotic</intervention_name>
    <description>Olanzapine: tablet ,5-20mg, Po q.d. Risperidone: tablet ,1-3 mg, Po q.d. Quetiapine: tablet ,100-400mg, Po b.i.d. ziprasidone : tablet ,40 -80mg, Po b.i.d.</description>
    <arm_group_label>schizophrenia</arm_group_label>
    <other_name>olanzapine, quetiapine , ziprasidone and risperidone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>atypical antipsychotic combined with MECT</intervention_name>
    <description>The schizophrenia who matches the indications such as severe negativism, refused to eating or stupor may be treated with antipsychotic combined with MECT, the frequency and times of MECT depend on the state of illness</description>
    <arm_group_label>schizophrenia</arm_group_label>
    <other_name>MECT means modified electric convulsive therapy</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The peripheral blood sample Plasma separated from the peripheral blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        the first-onset schizophrenia patients or drug-free suffers in the last 3 months，who are&#xD;
        Chinese of Han descent and admitted to the Dalian Seventh People's Hospital,China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons should be diagnosed with schizophrenia according to the International&#xD;
             Statistical Classification of Diseases and Related Health Problems 10th Revision&#xD;
             (ICD-10)&#xD;
&#xD;
          -  The first-onset or drug-free in the latest 3 months&#xD;
&#xD;
          -  Between the ages of 17-40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbid with other psychosis&#xD;
&#xD;
          -  Have physical or neurological diseases such as traumatic brain injuries&#xD;
&#xD;
          -  History of drug-abused or alcoholic&#xD;
&#xD;
          -  Blood transfusion history in a month&#xD;
&#xD;
          -  Been treated with Modified Electric Convulsive Therapy(MECT) in late 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shoufu Xie, postgraduate</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dalian Seventh People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guanghui Fu, postgraduate</last_name>
    <phone>86-188 4282 1307</phone>
    <email>fuguanghui1023@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shoufu Xie, postgraduate</last_name>
    <phone>86-0411 8451 4015</phone>
    <email>doctorxie1023@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dalian Seventh People's Hospital</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116023</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guanghui Fu, Postgraduate</last_name>
      <phone>86-188 4282 1307</phone>
      <email>fuguanghui1023@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Shoufu Xie, Postgraduate</last_name>
      <phone>86-0411 8451 4015</phone>
      <email>doctorxie1023@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Xu C, Liu X, Song X, Gao Q, Cheng L, Wang L, Zhang K, Xu Y. Aberrant resting state in microRNA-30e rat model of cognitive impairment. Neuroreport. 2016 Aug 3;27(11):809-17. doi: 10.1097/WNR.0000000000000616.</citation>
    <PMID>27258654</PMID>
  </results_reference>
  <results_reference>
    <citation>Xu Y, Li F, Zhang B, Zhang K, Zhang F, Huang X, Sun N, Ren Y, Sui M, Liu P. MicroRNAs and target site screening reveals a pre-microRNA-30e variant associated with schizophrenia. Schizophr Res. 2010 Jun;119(1-3):219-27. doi: 10.1016/j.schres.2010.02.1070. Epub 2010 Mar 27.</citation>
    <PMID>20347265</PMID>
  </results_reference>
  <results_reference>
    <citation>Banigan MG, Kao PF, Kozubek JA, Winslow AR, Medina J, Costa J, Schmitt A, Schneider A, Cabral H, Cagsal-Getkin O, Vanderburg CR, Delalle I. Differential expression of exosomal microRNAs in prefrontal cortices of schizophrenia and bipolar disorder patients. PLoS One. 2013;8(1):e48814. doi: 10.1371/journal.pone.0048814. Epub 2013 Jan 30.</citation>
    <PMID>23382797</PMID>
  </results_reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>January 28, 2020</last_update_submitted>
  <last_update_submitted_qc>January 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dalian Seventh People's Hospital</investigator_affiliation>
    <investigator_full_name>Shoufu Xie</investigator_full_name>
    <investigator_title>chief physician，Professor of Psychiatry,Vice president of the hospital</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micrognathism</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olanzapine</mesh_term>
    <mesh_term>Risperidone</mesh_term>
    <mesh_term>Quetiapine Fumarate</mesh_term>
    <mesh_term>Ziprasidone</mesh_term>
    <mesh_term>Antipsychotic Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03007303
org study id: GFu01
nct id: NCT03007303
lead sponsor: 
collaborator: 
has dmc: Yes
This study investigates the relationship of circulating microRNA-30e and schizophrenia, and
      shows the relevance of the aberrant microRNA-30e expression in plasma with the variation
      disease status.
The plasma samples from 15 individuals with schizophrenia (with a diagnosis of ICD-10) and
      the equivalent healthy controls will be conducted with the quantification analysis of the
      microRNA-30e via real-time quantitative polymerase chain reaction(RT-PCR).

      The 15 patients enrolled should be the first-episode and have not been treated, or were drug
      free 3 months recently at least.

      This research measures the expression level of microRNA-30e in schizophrenia respectively
      before the beginning treatment with atypical psychotics or combined with MECT, after the
      4-week treated , the 8-week treated compared with 15 healthy controls.
observational model: Case-Control
time perspective: Prospective
measure: the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
time frame: before the treatment
description: the plasma samples will be collected from the patients with schizophrenia and the healthy controls at the beginning recruit for the microRNA-30e detection
measure: the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
time frame: Change from Baseline expression level at 4-week treatment
description: the plasma samples will be collected from the patients with schizophrenia at the 4-week treatment for the microRNA-30e detection
measure: the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)
time frame: Change from Baseline expression level at 8-week treatment
description: the plasma samples will be collected from the patients with schizophrenia at the 8-week treatment for the microRNA-30e detection
measure: the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia
time frame: before, after 4 weeks and 8 weeks treatment
description: The PANSS for estimating the severity of positive and negative symptoms in schizophrenia
measure: The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia
time frame: before, after 4 weeks and 8 weeks treatment
description: The degree of Personal and Social Performance scale(PSP) used to evaluate the disable levels in Multiple dimensions ,especially in social and self-care performance
measure: The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment
time frame: 4 weeks and 8 weeks treatment
description: Main purpose to provide a global rating of illness severity ,improvement and response to treatment for the patients with schizophrenia
arm group label: schizophrenia
description: 15 patients with schizophrenia will be treated with anyone of the atypical psychotics(including olanzapine, quetiapine , ziprasidone and risperidone)or combined with MECT.
The fluctuating dosage depends on the changes of symptom according to the total scores of Positive and Negative Syndrome Scale from schizophrenia patients after treated.
arm group label: health controls
description: 15 healthy individuals were collected from Dalian seventh people's hospital and were matched on age and sex to schizophrenia group
intervention type: Drug
intervention name: Atypical Antipsychotic
description: Olanzapine: tablet ,5-20mg, Po q.d. Risperidone: tablet ,1-3 mg, Po q.d. Quetiapine: tablet ,100-400mg, Po b.i.d. ziprasidone : tablet ,40 -80mg, Po b.i.d.
arm group label: schizophrenia
other name: olanzapine, quetiapine , ziprasidone and risperidone
intervention type: Other
intervention name: atypical antipsychotic combined with MECT
description: The schizophrenia who matches the indications such as severe negativism, refused to eating or stupor may be treated with antipsychotic combined with MECT, the frequency and times of MECT depend on the state of illness
arm group label: schizophrenia
other name: MECT means modified electric convulsive therapy
The peripheral blood sample Plasma separated from the peripheral blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shoufu Xie, postgraduate
role: Principal Investigator
affiliation: Dalian Seventh People's Hospital
last name: Guanghui Fu, postgraduate
phone: 86-188 4282 1307
email: fuguanghui1023@126.com
last name: Shoufu Xie, postgraduate
phone: 86-0411 8451 4015
email: doctorxie1023@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Xu C, Liu X, Song X, Gao Q, Cheng L, Wang L, Zhang K, Xu Y. Aberrant resting state in microRNA-30e rat model of cognitive impairment. Neuroreport. 2016 Aug 3;27(11):809-17. doi: 10.1097/WNR.0000000000000616.
PMID: 27258654
citation: Xu Y, Li F, Zhang B, Zhang K, Zhang F, Huang X, Sun N, Ren Y, Sui M, Liu P. MicroRNAs and target site screening reveals a pre-microRNA-30e variant associated with schizophrenia. Schizophr Res. 2010 Jun;119(1-3):219-27. doi: 10.1016/j.schres.2010.02.1070. Epub 2010 Mar 27.
PMID: 20347265
citation: Banigan MG, Kao PF, Kozubek JA, Winslow AR, Medina J, Costa J, Schmitt A, Schneider A, Cabral H, Cagsal-Getkin O, Vanderburg CR, Delalle I. Differential expression of exosomal microRNAs in prefrontal cortices of schizophrenia and bipolar disorder patients. PLoS One. 2013;8(1):e48814. doi: 10.1371/journal.pone.0048814. Epub 2013 Jan 30.
PMID: 23382797
responsible party type: Principal Investigator
investigator affiliation: Dalian Seventh People's Hospital
investigator full name: Shoufu Xie
investigator title: chief physician，Professor of Psychiatry,Vice president of the hospital
mesh term: Micrognathism
mesh term: Schizophrenia
mesh term: Olanzapine
mesh term: Risperidone
mesh term: Quetiapine Fumarate
mesh term: Ziprasidone
mesh term: Antipsychotic Agents
sharing ipd: Yes