<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/NCT03784222</url>
  </required_header>
  <id_info>
    <org_study_id>DSPCLON-002</org_study_id>
    <nct_id>NCT03784222</nct_id>
  </id_info>
  <brief_title>Effects on Social and Cognition Functions of Blonanserin in First Episode Schizophrenia Patients</brief_title>
  <official_title>Effects on Social and Cognition Functions of Blonanserin in First Episode 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>
    <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 is an open label, multi-center study to explore the effects on social functions of&#xD;
      blonanserin in first episode schizophrenia patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Anticipated">July 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in personal and social performance (PSP) scores at week 26</measure>
    <time_frame>26 weeks</time_frame>
    <description>PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group</measure>
    <time_frame>26 weeks</time_frame>
    <description>MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group</measure>
    <time_frame>26 weeks</time_frame>
    <description>PASAT is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in Groove Pegboard Test (GPT) at week 26 in treatment group</measure>
    <time_frame>26 weeks</time_frame>
    <description>GPT is a test used to assess fine motor skills and speed. this test measure the time it takes to put 25 nails in the pegborad in a defined order</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group</measure>
    <time_frame>26 weeks</time_frame>
    <description>PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in PANSS five-factor model scores at week 26 in treatment group</measure>
    <time_frame>26 weeks</time_frame>
    <description>five-factor model is another model of PANSS. It is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in PSP at every visit in treatment group during 26 weeks</measure>
    <time_frame>baseline, week 8, week 26</time_frame>
    <description>PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in MCCB at every visit in treatment group during 26 weeks</measure>
    <time_frame>baseline, week 8, week 26</time_frame>
    <description>MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms</description>
  </secondary_outcome>
  <other_outcome>
    <measure>changes in magnetic resonance imaging (MRI) at week 26 in treatment group</measure>
    <time_frame>26 weeks</time_frame>
    <description>observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions</description>
  </other_outcome>
  <other_outcome>
    <measure>changes in MRI at every visit in treatment group during 26 weeks</measure>
    <time_frame>baseline, week 8, week 26</time_frame>
    <description>observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions</description>
  </other_outcome>
  <other_outcome>
    <measure>difference of MRI results between treatment group and control group at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions</description>
  </other_outcome>
  <other_outcome>
    <measure>changes in serum Brain-derived neurotrophic factor (BDNF) at week 26 in treatment group</measure>
    <time_frame>26 weeks</time_frame>
    <description>BDNF, is a protein that, in humans, is encoded by the BDNF gene. BDNF is a member of the neurotrophin family of growth factors, which are related to the canonical nerve growth factor. Neurotrophic factors are found in the brain and the periphery</description>
  </other_outcome>
  <other_outcome>
    <measure>difference of serum BDNF results between treatment group and control group at baseline</measure>
    <time_frame>baseline</time_frame>
    <description>BDNF, is a protein that, in humans, is encoded by the BDNF gene. BDNF is a member of the neurotrophin family of growth factors, which are related to the canonical nerve growth factor. Neurotrophic factors are found in the brain and the periphery</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">248</enrollment>
  <condition>First Episode Schizophrenia</condition>
  <condition>Social Function</condition>
  <condition>Cognition Function</condition>
  <condition>Blonanserin</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>60 subjects without schizophrenia, only receiving MRI and/or serum BDNF</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Blonanserin</intervention_name>
    <description>patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability</description>
    <arm_group_label>treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI and serum BDNF</intervention_name>
    <description>60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test</description>
    <arm_group_label>control group</arm_group_label>
    <arm_group_label>treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Schizophrenia patients diagnosis either with DSM-5 criteria or ICD-10;&#xD;
&#xD;
          -  PANSS total score ≥70;&#xD;
&#xD;
          -  Males or Females aged 18-45 years;&#xD;
&#xD;
          -  With disease course less than 5 years and during their first episode;&#xD;
&#xD;
          -  ≥9 years of education;&#xD;
&#xD;
          -  Without receiving systematic antipsychotic treatment, or receiving continuous&#xD;
             antipsychotic treatment for less than 6 weeks and receiving antipsychotic treatment&#xD;
             for less than 6 months in total;&#xD;
&#xD;
          -  Ability to read and understand Chinese;&#xD;
&#xD;
          -  Provision of written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe or unstable physical diseases judged by investigators;&#xD;
&#xD;
          -  Loss of consciousness more than 1 hour due to any reason in the past 1 year;&#xD;
&#xD;
          -  Current substance misuse (in 3 months) or any substance dependence;&#xD;
&#xD;
          -  Pregnant or lactating woman;&#xD;
&#xD;
          -  Patients with attempted suicide history, severe suicidal ideation or behaviour;&#xD;
&#xD;
          -  Mental retardation;&#xD;
&#xD;
          -  Contradict to the study drugs;&#xD;
&#xD;
          -  Patients taken other investigation products in the past 30 days before entry;&#xD;
&#xD;
          -  Patients ever taken blonanserin before;&#xD;
&#xD;
          -  Any current medical condition that would interfere with the assessment of efficacy;&#xD;
&#xD;
          -  Physical symptoms of acute deterioration requiring hospitalization or increased&#xD;
             intensive care;&#xD;
&#xD;
          -  Significant muscle tension or Parkinson's disease;&#xD;
&#xD;
          -  Clinically significant abnormal laboratory test results (blood, urine, and blood&#xD;
             biochemical analysis);&#xD;
&#xD;
          -  Clinically significant Abnormal electrocardiogram as judged by researchers;&#xD;
&#xD;
          -  Participants continuously using sedative drugs, or anticholinergic agents within 3&#xD;
             months of the study;&#xD;
&#xD;
          -  Those who had undergone electroconvulsive therapy within 3 month of the study;&#xD;
&#xD;
          -  Those who had received long-acting injection treatment within 3 month of the study;&#xD;
&#xD;
          -  Those who could not swallow medication with water;&#xD;
&#xD;
          -  Subjects judged by the investigator in charge as inappropriate for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Yu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Sixth Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Haiyun Li</last_name>
    <phone>+86-21-23065749</phone>
    <email>lihaiyun@dsmpharm.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Huilongguan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100096</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Yang Fude, MD</last_name>
      <email>Yangfd200@126.com</email>
    </contact>
    <investigator>
      <last_name>Yang Fude, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peking University Sixth Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xin Yu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhening Liu, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianhua Sheng, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xi'an Mental Health Center</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bin Wu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan Univeristy</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Deng, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Mental Health Center</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Lina Wang, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Shaohua Hu, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>April 11, 2023</last_update_submitted>
  <last_update_submitted_qc>April 11, 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>
  <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/NCT03784222
org study id: DSPCLON-002
nct id: NCT03784222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an open label, multi-center study to explore the effects on social functions of
      blonanserin in first episode schizophrenia patients
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes in personal and social performance (PSP) scores at week 26
time frame: 26 weeks
description: PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome
measure: changes in MATRICS Consensus Cognitive Battery (MCCB) domain scores at week 26 in treatment group
time frame: 26 weeks
description: MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms
measure: changes in Paced Auditory Serial Addition Task (PASAT) test at week 26 in treatment group
time frame: 26 weeks
description: PASAT is a neuropsychological test used to assess capacity and rate of information processing and sustained and divided attention
measure: changes in Groove Pegboard Test (GPT) at week 26 in treatment group
time frame: 26 weeks
description: GPT is a test used to assess fine motor skills and speed. this test measure the time it takes to put 25 nails in the pegborad in a defined order
measure: changes in positive and negative syndrome scale (PANSS) total scores at week 26 in treatment group
time frame: 26 weeks
description: PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales.
measure: changes in PANSS five-factor model scores at week 26 in treatment group
time frame: 26 weeks
description: five-factor model is another model of PANSS. It is a medical scale used for measuring symptom severity of patients with schizophrenia. the maximum scores is 210, the minimum scores is 30. the higher values represent a worse outcome. the total scores are the sum of subscales.
measure: changes in PSP at every visit in treatment group during 26 weeks
time frame: baseline, week 8, week 26
description: PSP consists of four main areas: 1. Socially useful activities (e.g., housework, voluntary work) including work and study; 2. Personal and social relationships (i.e., partner, family relationships, friends); 3. Self-care (i.e., personal hygiene, care of one's appearance); 4. Disturbing and aggressive behavior. The maximum scores is 100, the minimum scores is 1, higher values represent a better outcome
measure: changes in MCCB at every visit in treatment group during 26 weeks
time frame: baseline, week 8, week 26
description: MATRICS Consensus Cognitive Battery (MCCB) includes 10 tests that measure seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. Scores for the individual tests will be calculated according to the developer's recommended scoring algorithms
measure: changes in magnetic resonance imaging (MRI) at week 26 in treatment group
time frame: 26 weeks
description: observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions
measure: changes in MRI at every visit in treatment group during 26 weeks
time frame: baseline, week 8, week 26
description: observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions
measure: difference of MRI results between treatment group and control group at baseline
time frame: baseline
description: observe the change of grey matter volume, white matter volume, and the functions and connections in different encephalic regions
measure: changes in serum Brain-derived neurotrophic factor (BDNF) at week 26 in treatment group
time frame: 26 weeks
description: BDNF, is a protein that, in humans, is encoded by the BDNF gene. BDNF is a member of the neurotrophin family of growth factors, which are related to the canonical nerve growth factor. Neurotrophic factors are found in the brain and the periphery
measure: difference of serum BDNF results between treatment group and control group at baseline
time frame: baseline
description: BDNF, is a protein that, in humans, is encoded by the BDNF gene. BDNF is a member of the neurotrophin family of growth factors, which are related to the canonical nerve growth factor. Neurotrophic factors are found in the brain and the periphery
arm group label: treatment group
arm group type: Experimental
description: 188 first episode schizophrenia patients, receiving blonanserin treatment, 60 of the patients receive MRI and serum BDNF test
arm group label: control group
arm group type: Other
description: 60 subjects without schizophrenia, only receiving MRI and/or serum BDNF
intervention type: Drug
intervention name: Blonanserin
description: patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
arm group label: treatment group
intervention type: Other
intervention name: MRI and serum BDNF
description: 60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test
arm group label: control group
arm group label: treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xin Yu, MD
role: Principal Investigator
affiliation: Peking University Sixth Hospital
last name: Haiyun Li
phone: +86-21-23065749
email: lihaiyun@dsmpharm.com.cn
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No