<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/NCT03289026</url>
  </required_header>
  <id_info>
    <org_study_id>320-57-1706-1101-0001</org_study_id>
    <nct_id>NCT03289026</nct_id>
  </id_info>
  <brief_title>Pharmacologic Treatment of Acute Episode of Schizophrenia: a Real World Study</brief_title>
  <official_title>A Multicenter, Open-label Study to Evaluate the Effectiveness and Safety of Aripiprazole in Patients With Acute Episode of Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</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 study attempts to observe the effectiveness and safety of aripiprazole in hospitalized&#xD;
      patients with acute schizophrenia episode, and to compare the different drug regimens that&#xD;
      may be involved in order to clarify the characteristics of the population for taking&#xD;
      aripiprazole and provide reference for clinical rational drug use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The control of acute schizophrenia effectively and rapidly will build up the confidence of&#xD;
      patients on treatments. These early effects may influence the long-term compliance and&#xD;
      prognosis of patients. Aripiprazole is an important drug in first line treatment of&#xD;
      schizophrenia. However, at present in China, the application of aripiprazole in some patients&#xD;
      with acute schizophrenia is not appropriate, leading to poor control of the positive symptoms&#xD;
      of the acute phase.&#xD;
&#xD;
      The purpose of this single-arm, open-label trial is to study the situation of the use of&#xD;
      aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the&#xD;
      different drug regimens that may be involved in order to supply important information for&#xD;
      optimizing treatment strategies of hospitalized patients characterized by positive symptom.&#xD;
&#xD;
      The hospitalized patients characterized by positive symptom with acute schizophrenia episode&#xD;
      were recruited. At the time of enrollment, the demographic, symptomatic and laboratory data&#xD;
      was collected. After the completion of the baseline assessment and examination, the patients&#xD;
      were given aripiprazole. Clinical evaluation was performed at 1、2、4 and 8 weeks after&#xD;
      treatment, including the therapeutic efficacy and adverse drug reactions ,and monitoring of&#xD;
      laboratory data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">February 2, 2021</completion_date>
  <primary_completion_date type="Actual">January 23, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PANSS (positive and negative symptoms scale) total score</measure>
    <time_frame>baseline,8 weeks</time_frame>
    <description>Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PANSS positive score</measure>
    <time_frame>baseline,8 weeks</time_frame>
    <description>Change from baseline PANSS positive score at 8 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CGI-S (clinical general impression-severity)</measure>
    <time_frame>baseline,8 weeks</time_frame>
    <description>Change from baseline CGI-S (clinical general impression-severity) at 8 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PANSS negative score</measure>
    <time_frame>baseline,8 weeks</time_frame>
    <description>Change from baseline PANSS negative score at 8 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MSQ (Medication Satisfaction Questionnaire)score</measure>
    <time_frame>baseline,8 weeks</time_frame>
    <description>MSQ score at each assessment time point</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Fasting blood lipids</measure>
    <time_frame>baseline,4,8 weeks</time_frame>
    <description>Levels of fasting blood lipids</description>
  </other_outcome>
  <other_outcome>
    <measure>Fasting blood glucose</measure>
    <time_frame>baseline, 4,8 weeks</time_frame>
    <description>Levels of fasting blood glucose</description>
  </other_outcome>
  <other_outcome>
    <measure>Serum prolactin</measure>
    <time_frame>baseline, 4,8 weeks</time_frame>
    <description>Levels of serum prolactin</description>
  </other_outcome>
  <other_outcome>
    <measure>BMI (body mass index)</measure>
    <time_frame>baseline,1,2,4,8 weeks</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2</description>
  </other_outcome>
  <other_outcome>
    <measure>Waist circumference</measure>
    <time_frame>baseline,1,2,4,8 weeks</time_frame>
    <description>measurement of waist circumference in centimeters</description>
  </other_outcome>
  <other_outcome>
    <measure>Hip circumference</measure>
    <time_frame>baseline,1,2,4,8 weeks</time_frame>
    <description>measurement of hip circumference in centimeters</description>
  </other_outcome>
  <other_outcome>
    <measure>Occurrence of adverse reactions</measure>
    <time_frame>baseline,1,2,4,8 weeks</time_frame>
    <description>Occurrence of adverse reactions will be recorded</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">770</enrollment>
  <condition>Acute Schizophrenia Episode</condition>
  <arm_group>
    <arm_group_label>aripiprazole group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive aripiprazole treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aripiprazole</intervention_name>
    <description>Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator.</description>
    <arm_group_label>aripiprazole group</arm_group_label>
    <other_name>Aripiprazole Orally Disintegrating Tablets; Bosiqing®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients meeting International Classification of Diseases (tenth version, ICD-10)&#xD;
             criteria for schizophrenia.&#xD;
&#xD;
          -  acute episode; inpatients&#xD;
&#xD;
          -  Age from 18-65 years old (inclusion), male or female&#xD;
&#xD;
          -  PANSS total score at least 70&#xD;
&#xD;
          -  scoring ≥ 4 on at least two of the following PANSS items: P1 (delusions), P2&#xD;
             (conceptual disorganisation), P3 (hallucinations), P6 (suspiciousness/persecution) ;&#xD;
             and PANSS positive score is higher than PANSS negative score&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other serious diseases;&#xD;
&#xD;
          -  Pregnant or breast feeding women or planning a pregnancy&#xD;
&#xD;
          -  Patients in a state of drug-induced malignant syndrome or serious extrapyramidal side&#xD;
             effect, or with a history of malignant syndrome or serious extrapyramidal side effect;&#xD;
&#xD;
          -  Patients who, in the opinion of the investigator, pose an imminent risk of suicide or&#xD;
             a danger to self or others&#xD;
&#xD;
          -  Allergy to Aripiprazole&#xD;
&#xD;
          -  History of alcohol or drug abuse or dependence in the past 1-year before screening&#xD;
&#xD;
          -  mental retardation; bipolar disorder; major depressive disorder;&#xD;
&#xD;
          -  Currently using one kind of antipsychotic drug at a dose that exceeds the recommended&#xD;
             maximum dose for two weeks, but no improvement in core symptoms; or currently using&#xD;
             two kinds of antipsychotic drugs, at least one of which reaches or exceeds the&#xD;
             recommended maximum dose for two weeks, but no improvement in core symptoms; or&#xD;
             currently using three kinds of antipsychotic drugs or more;&#xD;
&#xD;
          -  Refractory schizophrenia patients who did not respond to treatments of two different&#xD;
             type antipsychotics with adequate dose and course&#xD;
&#xD;
          -  Patients with clinically significant abnormalities on electrocardiogram or laboratory&#xD;
             tests&#xD;
&#xD;
          -  Patients with clinically significant abnormalities on liver function (ALT or AST&gt;2&#xD;
             times of higher limit of normal range)&#xD;
&#xD;
          -  Patients who had Electroconvulsive Therapy (ECT) in the past 2 months&#xD;
&#xD;
          -  Participation in a clinical trial of another drug within 4 weeks prior to study entry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Fourth People's Hospital of Hefei</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <zip>230000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Anding Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing HuiLongGuan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100096</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Sixth Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Haerbin Psychiatric Hospital</name>
      <address>
        <city>Ha'erbin</city>
        <state>Heilongjiang</state>
        <zip>150056</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Mental Health Center</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>102 Miltary Hospital of China</name>
      <address>
        <city>Changzhou</city>
        <state>Jiangsu</state>
        <zip>213003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Mental Health Center</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fourth People's Hospital of Chengdu</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610036</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hangzhou Seventh People's Hospital</name>
      <address>
        <city>Hanzhou</city>
        <state>Zhejiang</state>
        <zip>310013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>February 3, 2021</last_update_submitted>
  <last_update_submitted_qc>February 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Si Tianmei</investigator_full_name>
    <investigator_title>Director of Clinical Psychopharmacology Division, Peking University Sixth Hospital</investigator_title>
  </responsible_party>
  <keyword>Aripiprazole; Acute schizophrenia episode; positive symptoms</keyword>
  <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>Aripiprazole</mesh_term>
  </intervention_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/NCT03289026
org study id: 320-57-1706-1101-0001
nct id: NCT03289026
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study attempts to observe the effectiveness and safety of aripiprazole in hospitalized
      patients with acute schizophrenia episode, and to compare the different drug regimens that
      may be involved in order to clarify the characteristics of the population for taking
      aripiprazole and provide reference for clinical rational drug use.
The control of acute schizophrenia effectively and rapidly will build up the confidence of
      patients on treatments. These early effects may influence the long-term compliance and
      prognosis of patients. Aripiprazole is an important drug in first line treatment of
      schizophrenia. However, at present in China, the application of aripiprazole in some patients
      with acute schizophrenia is not appropriate, leading to poor control of the positive symptoms
      of the acute phase.

      The purpose of this single-arm, open-label trial is to study the situation of the use of
      aripiprazole in hospitalized patients with acute schizophrenia episode, and to compare the
      different drug regimens that may be involved in order to supply important information for
      optimizing treatment strategies of hospitalized patients characterized by positive symptom.

      The hospitalized patients characterized by positive symptom with acute schizophrenia episode
      were recruited. At the time of enrollment, the demographic, symptomatic and laboratory data
      was collected. After the completion of the baseline assessment and examination, the patients
      were given aripiprazole. Clinical evaluation was performed at 1、2、4 and 8 weeks after
      treatment, including the therapeutic efficacy and adverse drug reactions ,and monitoring of
      laboratory data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PANSS (positive and negative symptoms scale) total score
time frame: baseline,8 weeks
description: Change from baseline PANSS (positive and negative symptoms scale) total score at 8 weeks
measure: PANSS positive score
time frame: baseline,8 weeks
description: Change from baseline PANSS positive score at 8 weeks
measure: CGI-S (clinical general impression-severity)
time frame: baseline,8 weeks
description: Change from baseline CGI-S (clinical general impression-severity) at 8 weeks
measure: PANSS negative score
time frame: baseline,8 weeks
description: Change from baseline PANSS negative score at 8 weeks
measure: MSQ (Medication Satisfaction Questionnaire)score
time frame: baseline,8 weeks
description: MSQ score at each assessment time point
measure: Fasting blood lipids
time frame: baseline,4,8 weeks
description: Levels of fasting blood lipids
measure: Fasting blood glucose
time frame: baseline, 4,8 weeks
description: Levels of fasting blood glucose
measure: Serum prolactin
time frame: baseline, 4,8 weeks
description: Levels of serum prolactin
measure: BMI (body mass index)
time frame: baseline,1,2,4,8 weeks
description: weight and height will be combined to report BMI in kg/m^2
measure: Waist circumference
time frame: baseline,1,2,4,8 weeks
description: measurement of waist circumference in centimeters
measure: Hip circumference
time frame: baseline,1,2,4,8 weeks
description: measurement of hip circumference in centimeters
measure: Occurrence of adverse reactions
time frame: baseline,1,2,4,8 weeks
description: Occurrence of adverse reactions will be recorded
arm group label: aripiprazole group
arm group type: Experimental
description: Patients receive aripiprazole treatment
intervention type: Drug
intervention name: Aripiprazole
description: Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator.
arm group label: aripiprazole group
other name: Aripiprazole Orally Disintegrating Tablets; Bosiqing®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Si Tianmei
investigator title: Director of Clinical Psychopharmacology Division, Peking University Sixth Hospital
mesh term: Schizophrenia
mesh term: Aripiprazole
sharing ipd: No