<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/NCT04432688</url>
  </required_header>
  <id_info>
    <org_study_id>DSPCLAT-001</org_study_id>
    <nct_id>NCT04432688</nct_id>
  </id_info>
  <brief_title>The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients</brief_title>
  <official_title>The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sumitomo Pharma (Suzhou) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sumitomo Pharma (Suzhou) Co., Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      It's a prospective, non-interventional, observational Post-marketing Surveillance..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It's a prospective, non-interventional, observational Post-marketing Surveillance, the aim of&#xD;
      the surveillance is to observe the safety and overall effectiveness of Latuda® in the&#xD;
      treatment of Chinese patients with schizophrenia for 12 weeks in real clinical practice, as&#xD;
      well as the dose of Latuda® for monotherapy or combination therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Weeks</target_duration>
  <primary_outcome>
    <measure>The incidence of Adverse Event</measure>
    <time_frame>week 12</time_frame>
    <description>Adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of extrapyramidal symptom</measure>
    <time_frame>baseline/ week 2-4/ week 6-8/ week 12</time_frame>
    <description>Extrapyramidal Symptoms (EPS) are drug-induced movement disorders that accur due to antipsychotic blockade of the nigrostriatal dopamine tracts, including acute dystonia, akathisia, antipsychotic-induced parkinsonism, tardive dyskinesia (TD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of akathisia</measure>
    <time_frame>baseline/ week 2-4/ week 6-8/ week 12</time_frame>
    <description>Akathisia is a side effect of antipsychotic drugs, presenting as restlessness, fidgeting of the legs, rocking, pacing, and the inability to sit or stand still.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rate of use of extrapyramidal symptom treatment drugs</measure>
    <time_frame>baseline/ week 2-4/ week 6-8/ week 12</time_frame>
    <description>extrapyramidal symptom treatment drugs are medications to decrease extrapyramidal side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in body weight at the end of treatment compared with baseline</measure>
    <time_frame>baseline/ week 12</time_frame>
    <description>Weight is measured on a scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The overall Brief Psychiatric Rating Scale (BPRS) score change at the end of the treatment compared with the baseline</measure>
    <time_frame>baseline/ week 2-4/ week 6-8/ week 12</time_frame>
    <description>Brief Psychiatric Rating Scale (BPRS) is a generic scale developed to measure clinical change in patients with schizophrenia and which can be used as a global measure of psychopathology. Each of the 18 items are designed to represent a discrete symptom area. Items are rated on a 7-point Likert scale, from 1 = &quot;not present&quot; to 7 = &quot;extremely severe&quot;, with scores ranging from 18 to 126 (achieved through summing the item scores).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Latuda®</arm_group_label>
    <description>Chinese schizophrenia patients who are receiving Latuda® in the real world</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lurasidone HCl</intervention_name>
    <description>This is a non-interventional, observational study</description>
    <arm_group_label>Latuda®</arm_group_label>
    <other_name>Latuda®</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Schizophrenia Patients who begin to receive Latuda®&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Schizophrenia Patients who begin to receive Latuda®&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  No exclusion criteria&#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>Yifeng Xu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Anding Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first specialized hospital of Harbin</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150056</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brain Hospital of Hunan Province</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</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>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Shanxi Medical University</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Anding Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300074</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2023</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lurasidone Hydrochloride</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/NCT04432688
org study id: DSPCLAT-001
nct id: NCT04432688
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
It's a prospective, non-interventional, observational Post-marketing Surveillance..
It's a prospective, non-interventional, observational Post-marketing Surveillance, the aim of
      the surveillance is to observe the safety and overall effectiveness of Latuda® in the
      treatment of Chinese patients with schizophrenia for 12 weeks in real clinical practice, as
      well as the dose of Latuda® for monotherapy or combination therapy.
observational model: Case-Only
time perspective: Prospective
measure: The incidence of Adverse Event
time frame: week 12
description: Adverse events
measure: The incidence of extrapyramidal symptom
time frame: baseline/ week 2-4/ week 6-8/ week 12
description: Extrapyramidal Symptoms (EPS) are drug-induced movement disorders that accur due to antipsychotic blockade of the nigrostriatal dopamine tracts, including acute dystonia, akathisia, antipsychotic-induced parkinsonism, tardive dyskinesia (TD)
measure: The incidence of akathisia
time frame: baseline/ week 2-4/ week 6-8/ week 12
description: Akathisia is a side effect of antipsychotic drugs, presenting as restlessness, fidgeting of the legs, rocking, pacing, and the inability to sit or stand still.
measure: the rate of use of extrapyramidal symptom treatment drugs
time frame: baseline/ week 2-4/ week 6-8/ week 12
description: extrapyramidal symptom treatment drugs are medications to decrease extrapyramidal side effects
measure: Changes in body weight at the end of treatment compared with baseline
time frame: baseline/ week 12
description: Weight is measured on a scale
measure: The overall Brief Psychiatric Rating Scale (BPRS) score change at the end of the treatment compared with the baseline
time frame: baseline/ week 2-4/ week 6-8/ week 12
description: Brief Psychiatric Rating Scale (BPRS) is a generic scale developed to measure clinical change in patients with schizophrenia and which can be used as a global measure of psychopathology. Each of the 18 items are designed to represent a discrete symptom area. Items are rated on a 7-point Likert scale, from 1 = "not present" to 7 = "extremely severe", with scores ranging from 18 to 126 (achieved through summing the item scores).
arm group label: Latuda®
description: Chinese schizophrenia patients who are receiving Latuda® in the real world
intervention type: Drug
intervention name: Lurasidone HCl
description: This is a non-interventional, observational study
arm group label: Latuda®
other name: Latuda®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yifeng Xu
role: Principal Investigator
affiliation: Shanghai Mental Health Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Lurasidone Hydrochloride
sharing ipd: No