<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/NCT03237052</url>
  </required_header>
  <id_info>
    <org_study_id>VOMAS-C</org_study_id>
    <nct_id>NCT03237052</nct_id>
  </id_info>
  <brief_title>Validating and Optimizing Model of Antipsychotics Selection</brief_title>
  <official_title>A Randomized Controlled Multi-center Clinical Study Focusing on Validating and Optimizing Model of Antipsychotics Selection in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Mental Health Center</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>
      This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics&#xD;
      treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world&#xD;
      psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per&#xD;
      day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main&#xD;
      purpose of this study is to explore the potential difference between modal-aided-decision&#xD;
      with clinician-decision in order to validate and optimize the selection model that has been&#xD;
      established in advance.&#xD;
&#xD;
      The efficacy evaluations include symptoms, social function, recurrence rate and&#xD;
      hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of PSP from Baseline</measure>
    <time_frame>52 weeks</time_frame>
    <description>PSP assessment at 52 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of PANSS from Baseline</measure>
    <time_frame>52 weeks</time_frame>
    <description>PANSS assessment at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of CDSS from Baseline</measure>
    <time_frame>52 weeks</time_frame>
    <description>CDSS assessment at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of CGI from Baseline</measure>
    <time_frame>52 weeks</time_frame>
    <description>CGI assessment at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of liver function from Baseline</measure>
    <time_frame>52 weeks</time_frame>
    <description>Liver function assessment at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of PRL from Baseline</measure>
    <time_frame>52 weeks</time_frame>
    <description>PRL assessment at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with EPS</measure>
    <time_frame>52 weeks</time_frame>
    <description>EPS assessment at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with abnormal ECG</measure>
    <time_frame>52 weeks</time_frame>
    <description>ECG assessment at 52 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with abnormal sexual function</measure>
    <time_frame>52 weeks</time_frame>
    <description>sexual function assessment at 52 weeks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>model</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>model aided decision</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-model</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>real-world psychiatrist decision</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>model</intervention_name>
    <description>a model that has been established in advance.</description>
    <arm_group_label>model</arm_group_label>
    <other_name>model aided decision</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-model</intervention_name>
    <description>real-world psychiatrist decision</description>
    <arm_group_label>non-model</arm_group_label>
    <other_name>non-model decision</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An in-patient or out-patient (male or female) and aged ≥18 years&#xD;
&#xD;
          -  A diagnosis of schizophrenia, DSM-5 (Diagnostic and Statistical Manual Diploma in&#xD;
             Social Medicine-5)&#xD;
&#xD;
          -  Subjects must have the ability to effectively communicate with investigator, complete&#xD;
             study related documents, comprehend the key components of the consent form and must&#xD;
             provide written informed consent to participate in the study prior to any study&#xD;
             specific assessments or procedures.&#xD;
&#xD;
          -  Patients are taking or will take atypical antipsychotics which include olanzapine,&#xD;
             risperidone, aripiprazole.&#xD;
&#xD;
          -  Baseline PANSS Total Score ≥70&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in other clinical studies.&#xD;
&#xD;
          -  Known intolerance or lack of efficacy to olanzapine, risperidone or aripiprazole.&#xD;
&#xD;
          -  Use of clozapine within 28 days prior to randomization.&#xD;
&#xD;
          -  Other conditions which, in the investigator's judgment, render patients unsuitable for&#xD;
             the clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yifeng SHEN, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GCP Office</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yifeng SHEN, MD PhD</last_name>
    <phone>86-21-34773657</phone>
    <email>shenyifeng@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yifeng SHEN, MD</last_name>
      <phone>+862134773657</phone>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 29, 2017</study_first_submitted>
  <study_first_submitted_qc>July 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>August 7, 2019</last_update_submitted>
  <last_update_submitted_qc>August 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</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>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03237052
org study id: VOMAS-C
nct id: NCT03237052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This multi-centre study will evaluate the clinical efficacy of 3 atypical antipsychotics
      treatment in Chinese Patients with Schizophrenia by comparing model-decision with real-world
      psychiatrist-decision. The three atypical antipsychotics are olanzapine (5-20 milligram per
      day), risperidone (2-6 milligram per day) and aripiprazole (5-30 milligram per day). The main
      purpose of this study is to explore the potential difference between modal-aided-decision
      with clinician-decision in order to validate and optimize the selection model that has been
      established in advance.

      The efficacy evaluations include symptoms, social function, recurrence rate and
      hospitalization. Visits occurs at 0, 4, 8, 13, 26, 52 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change of PSP from Baseline
time frame: 52 weeks
description: PSP assessment at 52 weeks
measure: Change of PANSS from Baseline
time frame: 52 weeks
description: PANSS assessment at 52 weeks
measure: Change of CDSS from Baseline
time frame: 52 weeks
description: CDSS assessment at 52 weeks
measure: Change of CGI from Baseline
time frame: 52 weeks
description: CGI assessment at 52 weeks
measure: Change of liver function from Baseline
time frame: 52 weeks
description: Liver function assessment at 52 weeks
measure: Change of PRL from Baseline
time frame: 52 weeks
description: PRL assessment at 52 weeks
measure: Number of Participants with EPS
time frame: 52 weeks
description: EPS assessment at 52 weeks
measure: Number of Participants with abnormal ECG
time frame: 52 weeks
description: ECG assessment at 52 weeks
measure: Number of Participants with abnormal sexual function
time frame: 52 weeks
description: sexual function assessment at 52 weeks
arm group label: model
arm group type: Experimental
description: model aided decision
arm group label: non-model
arm group type: Active Comparator
description: real-world psychiatrist decision
intervention type: Other
intervention name: model
description: a model that has been established in advance.
arm group label: model
other name: model aided decision
intervention type: Other
intervention name: non-model
description: real-world psychiatrist decision
arm group label: non-model
other name: non-model decision
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yifeng SHEN, MD PhD
role: Principal Investigator
affiliation: GCP Office
last name: Yifeng SHEN, MD PhD
phone: 86-21-34773657
email: shenyifeng@yahoo.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No