<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/NCT02192723</url>
  </required_header>
  <id_info>
    <org_study_id>Project863</org_study_id>
    <nct_id>NCT02192723</nct_id>
  </id_info>
  <brief_title>A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia</brief_title>
  <official_title>Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing HuiLongGuan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing HuiLongGuan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy and side effects of 6 commonly used&#xD;
      antipsychotic drugs in the treatment of schizophrenia in a Chinese population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared&#xD;
      with that of older agents has been incompletely addressed, though newer agents are currently&#xD;
      used far more commonly. The investigators compared a first-generation antipsychotic,&#xD;
      perphenazine or haloperidol, with several newer drugs in a double-blind study.&#xD;
&#xD;
      METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and&#xD;
      randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per&#xD;
      day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10&#xD;
      to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Global Impression (CGI)</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>The UKU Side Effect Rating Scale is a comprehensive, clinician-rated scale, designed to assess the side effects in patients treated with psychotropic medications.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">550</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Typical antipsychotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Haloperidol (6~20mg/day) and perphenazine (16~64mg/day) for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Risperidone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Risperidone, 2~6mg/day, twice day, 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Olanzapine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5~20mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quetiapine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>400~750mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aripiprazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aripiprazole, 10~30mg/day, twice per day, 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ziprasidone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ziprasidone, 80~160mg/day, twice per day, 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Typical antipsychotic</intervention_name>
    <description>Haloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks</description>
    <arm_group_label>Typical antipsychotic</arm_group_label>
    <other_name>Haldol and Trilafon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Risperidone</intervention_name>
    <description>2~6mg/day, twice per day, 8 weeks</description>
    <arm_group_label>Risperidone</arm_group_label>
    <other_name>Risperdal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olanzapine</intervention_name>
    <description>Olanzapine, 400~750mg/day, twice per day, 8 weeks</description>
    <arm_group_label>Olanzapine</arm_group_label>
    <other_name>Zyprexa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Quetiapine</intervention_name>
    <description>Quetiapine, 400～750mg/day, twice per day, 8 weeks</description>
    <arm_group_label>Quetiapine</arm_group_label>
    <other_name>Seroquel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Aripiprazole</intervention_name>
    <description>Aripiprazole, 10～30mg/day, twice per day, 8 weeks</description>
    <arm_group_label>Aripiprazole</arm_group_label>
    <other_name>Abilify</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ziprasidone</intervention_name>
    <description>Ziprasidone 80~160mg/day, twice per day, 8 weeks</description>
    <arm_group_label>Ziprasidone</arm_group_label>
    <other_name>Geodon</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients' diagnoses is based on the results of the Structured Clinical Interview for&#xD;
             DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical&#xD;
             Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory&#xD;
             tests. Attending-level psychiatrists will use a Chinese translation of the SCID to&#xD;
             interview patients and their family members, who are given freedom to ask additional&#xD;
             questions if respondents do not understand the standard probes.&#xD;
&#xD;
          -  Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2)&#xD;
             duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5)&#xD;
             have NOT received antipsychotic medication for at least 1 month;(6) acute&#xD;
             exacerbations of chronic inpatients.&#xD;
&#xD;
          -  A complete medical history, electroencephalograms and electrocardiogram are obtained,&#xD;
             and a physical examination and laboratory tests are performed at study entrance. None&#xD;
             of the study participants have abnormal findings on these tests.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhi-Ren Wang, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Beijing HuiLongGuan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing HuiLongGuan Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100096</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>July 10, 2016</last_update_submitted>
  <last_update_submitted_qc>July 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing HuiLongGuan Hospital</investigator_affiliation>
    <investigator_full_name>Xiang Yang Zhang</investigator_full_name>
    <investigator_title>Director, the Research Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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>Aripiprazole</mesh_term>
    <mesh_term>Quetiapine Fumarate</mesh_term>
    <mesh_term>Ziprasidone</mesh_term>
    <mesh_term>Antipsychotic Agents</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/NCT02192723
org study id: Project863
nct id: NCT02192723
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the efficacy and side effects of 6 commonly used
      antipsychotic drugs in the treatment of schizophrenia in a Chinese population.
The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared
      with that of older agents has been incompletely addressed, though newer agents are currently
      used far more commonly. The investigators compared a first-generation antipsychotic,
      perphenazine or haloperidol, with several newer drugs in a double-blind study.

      METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and
      randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per
      day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10
      to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Positive and Negative Syndrome Scale (PANSS)
time frame: Baseline, 8 weeks
measure: Clinical Global Impression (CGI)
time frame: Baseline, 8 weeks
description: The Clinical Global Impression rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders
measure: Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale
time frame: Baseline, 8 weeks
description: The UKU Side Effect Rating Scale is a comprehensive, clinician-rated scale, designed to assess the side effects in patients treated with psychotropic medications.
arm group label: Typical antipsychotic
arm group type: Experimental
description: Haloperidol (6~20mg/day) and perphenazine (16~64mg/day) for 8 weeks.
arm group label: Risperidone
arm group type: Active Comparator
description: Risperidone, 2~6mg/day, twice day, 8 weeks
arm group label: Olanzapine
arm group type: Active Comparator
description: 5~20mg/day
arm group label: Quetiapine
arm group type: Active Comparator
description: 400~750mg/day
arm group label: Aripiprazole
arm group type: Active Comparator
description: Aripiprazole, 10~30mg/day, twice per day, 8 weeks
arm group label: Ziprasidone
arm group type: Active Comparator
description: Ziprasidone, 80~160mg/day, twice per day, 8 weeks
intervention type: Drug
intervention name: Typical antipsychotic
description: Haloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks
arm group label: Typical antipsychotic
other name: Haldol and Trilafon
intervention type: Drug
intervention name: Risperidone
description: 2~6mg/day, twice per day, 8 weeks
arm group label: Risperidone
other name: Risperdal
intervention type: Drug
intervention name: Olanzapine
description: Olanzapine, 400~750mg/day, twice per day, 8 weeks
arm group label: Olanzapine
other name: Zyprexa
intervention type: Drug
intervention name: Quetiapine
description: Quetiapine, 400～750mg/day, twice per day, 8 weeks
arm group label: Quetiapine
other name: Seroquel
intervention type: Device
intervention name: Aripiprazole
description: Aripiprazole, 10～30mg/day, twice per day, 8 weeks
arm group label: Aripiprazole
other name: Abilify
intervention type: Drug
intervention name: Ziprasidone
description: Ziprasidone 80~160mg/day, twice per day, 8 weeks
arm group label: Ziprasidone
other name: Geodon
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: No
last name: Zhi-Ren Wang, MD, PhD
role: Study Director
affiliation: Beijing HuiLongGuan Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing HuiLongGuan Hospital
investigator full name: Xiang Yang Zhang
investigator title: Director, the Research Center
mesh term: Schizophrenia
mesh term: Olanzapine
mesh term: Risperidone
mesh term: Aripiprazole
mesh term: Quetiapine Fumarate
mesh term: Ziprasidone
mesh term: Antipsychotic Agents