<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/NCT03302364</url>
  </required_header>
  <id_info>
    <org_study_id>2016[1240]</org_study_id>
    <nct_id>NCT03302364</nct_id>
  </id_info>
  <brief_title>A Research in Pharmacogenomics and Accurate Medication of Risperidone</brief_title>
  <official_title>A Research in Pharmacogenomics and Accurate Medication of Risperidone</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cui Yimin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Risperidone is a selective monoamine receptor antagonist. It plays an antipsychotic effect by&#xD;
      antagonizing 5-HT2 / D2 receptor. As a second-generation antipsychotic drug, risperidone is&#xD;
      metabolized to 9-hydroxy Risperidone in the body very quickly. There are individual&#xD;
      differences in the pharmacokinetics and pharmacodynamics of risperidone. For example, CYP2D6&#xD;
      genotype can greatly affect the metabolism of risperidone, and provide evidence for adjusting&#xD;
      the type and dose of medication to treat Schizophrenia. In this study, we will verify the&#xD;
      correlation between the polymorphisms of genes related with risperidone drug metabolites,&#xD;
      drug transporters, drug targets and drug metabolism, pharmacodynamics, adverse reactions in&#xD;
      Chinese population, providing basis for clinical rational use of risperidone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects with schizophrenia will be recuited from several sub-centers. The relevant gene&#xD;
      polymorphisms and risperidone drug metabolism, drug adverse reaction parameters are monitored&#xD;
      through drawing blood samples at 0h, 6h, D27 and D56 of the risperidone drug administration.&#xD;
      Information related to drug pharmacokinetics, pharmacodynamics and adverse reactions(serum&#xD;
      prolactin levels) will be collected and analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 22, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>8 Weeks</target_duration>
  <primary_outcome>
    <measure>genotype</measure>
    <time_frame>Pre-dose of risperidone</time_frame>
    <description>The genotypes of subjects are detected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prolactin concentration in plasma</measure>
    <time_frame>Hour 0, Weeks 6-8</time_frame>
    <description>Prolactin concentration is determined by ELISA method, it is one of the ADR of prolactin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>risperidone and 9-OH-risperidone concentration in plasma</measure>
    <time_frame>day 1,day 2</time_frame>
    <description>Risperidone and 9-OH-risperidone concentration are PK outcomes for evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative and positive scale</measure>
    <time_frame>day-1,day28±2，day56±2</time_frame>
    <description>PANSS scole of patients</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">800</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Mental Illness</condition>
  <arm_group>
    <arm_group_label>risperidone patients</arm_group_label>
    <description>patients that are in accordance with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychological Interview(MINI)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperidone</intervention_name>
    <description>patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment</description>
    <arm_group_label>risperidone patients</arm_group_label>
    <other_name>Risperidal</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood samples will be drawn and collected, serum sample will also be obtained by&#xD;
      centrifugation of whole blood at 4 ℃. The collected samples will be further detected and the&#xD;
      concentration data will be used for PG-PK, PG-PD and PG-ADR analyses.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Schizophrenic patients who are going to be treated with risperidone.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients that meet with DSM-IV-TR schizophrenia diagnostic criteria, based on concise&#xD;
             International Neuropsychiatric Interview (MINI);&#xD;
&#xD;
          -  patients who have never received risperidone treatment or who need re-administration&#xD;
             of risperidone after previous treatment with risperidone;&#xD;
&#xD;
          -  Subjects and / or their guardians who agree to sign the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who use CYP2D6 or CYP3A4 inducers or inhibitors as treatment drugs;&#xD;
&#xD;
          -  patients with hepatic insufficiency;&#xD;
&#xD;
          -  patients with renal insufficiency;&#xD;
&#xD;
          -  patients who use other drugs that interact with risperidone;&#xD;
&#xD;
          -  certain patients that the researchers consider to be unsuitable for the clinical&#xD;
             trail.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yimin Cui, Ph.D &amp; M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qian Xiang, Ph.D</last_name>
    <phone>+86 010 66110802</phone>
    <email>xiangqz@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qian Xiang, Ph.D</last_name>
      <phone>01066110802</phone>
      <email>xiangqz@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Cui Yimin</investigator_full_name>
    <investigator_title>Director of Pharmacy,M.D.&amp; Ph.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Risperidone</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/NCT03302364
org study id: 2016[1240]
nct id: NCT03302364
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Risperidone is a selective monoamine receptor antagonist. It plays an antipsychotic effect by
      antagonizing 5-HT2 / D2 receptor. As a second-generation antipsychotic drug, risperidone is
      metabolized to 9-hydroxy Risperidone in the body very quickly. There are individual
      differences in the pharmacokinetics and pharmacodynamics of risperidone. For example, CYP2D6
      genotype can greatly affect the metabolism of risperidone, and provide evidence for adjusting
      the type and dose of medication to treat Schizophrenia. In this study, we will verify the
      correlation between the polymorphisms of genes related with risperidone drug metabolites,
      drug transporters, drug targets and drug metabolism, pharmacodynamics, adverse reactions in
      Chinese population, providing basis for clinical rational use of risperidone.
Subjects with schizophrenia will be recuited from several sub-centers. The relevant gene
      polymorphisms and risperidone drug metabolism, drug adverse reaction parameters are monitored
      through drawing blood samples at 0h, 6h, D27 and D56 of the risperidone drug administration.
      Information related to drug pharmacokinetics, pharmacodynamics and adverse reactions(serum
      prolactin levels) will be collected and analyzed.
observational model: Cohort
time perspective: Prospective
measure: genotype
time frame: Pre-dose of risperidone
description: The genotypes of subjects are detected.
measure: Prolactin concentration in plasma
time frame: Hour 0, Weeks 6-8
description: Prolactin concentration is determined by ELISA method, it is one of the ADR of prolactin.
measure: risperidone and 9-OH-risperidone concentration in plasma
time frame: day 1,day 2
description: Risperidone and 9-OH-risperidone concentration are PK outcomes for evaluation.
measure: Negative and positive scale
time frame: day-1,day28±2，day56±2
description: PANSS scole of patients
arm group label: risperidone patients
description: patients that are in accordance with DSM-IV-TR schizophrenia diagnostic criteria, based on concise International Neuropsychological Interview(MINI)
intervention type: Drug
intervention name: Risperidone
description: patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment
arm group label: risperidone patients
other name: Risperidal
Whole blood samples will be drawn and collected, serum sample will also be obtained by
      centrifugation of whole blood at 4 ℃. The collected samples will be further detected and the
      concentration data will be used for PG-PK, PG-PD and PG-ADR analyses.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yimin Cui, Ph.D & M.D
role: Principal Investigator
affiliation: Peking University First Hospital
last name: Qian Xiang, Ph.D
phone: +86 010 66110802
email: xiangqz@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Cui Yimin
investigator title: Director of Pharmacy,M.D.& Ph.D.
mesh term: Schizophrenia
mesh term: Mental Disorders
mesh term: Risperidone