<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/NCT03802838</url>
  </required_header>
  <id_info>
    <org_study_id>ZHYY-ZXYJHZX-2-201708</org_study_id>
    <nct_id>NCT03802838</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia</brief_title>
  <official_title>Clinical Evaluation of Acupuncture Treatment for Negative Symptoms of Schizophrenia</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>Yes</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>
      To explore the effects of combined traditional Chinese and Western medicine( Chinese&#xD;
      acupuncture combined with Amisulpride Tablets) on negative symptoms, cognitive function and&#xD;
      social function in patients with schizophrenia, and the side effects and safety of Chinese&#xD;
      acupuncture combined with Amisulpride Tablets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our research hypothesis：1. Medically assisted Acupuncture in schizophrenia can improve&#xD;
      negative symptoms；2. Drug assisted Acupuncture Therapy has better cognitive function in&#xD;
      schizophrenic patients than single drug；3. Schizophrene with acupuncture have fewer and&#xD;
      lighter adverse reactions。This study was carried out only in Shanghai Mental Health Center.&#xD;
      It was a parallel randomized study.Schizophrene with negative symptoms were treated with&#xD;
      atypical antipsychotic drug amisulpride, but still remained negative symptoms. Using the&#xD;
      mature Chinese medicine therapy acupuncture auxiliary treatment, using the more reliable&#xD;
      clinical evaluation method (the grader blind method: The raters were not sure which patients&#xD;
      were the study group or the control group), compared with the single drug treatment, To&#xD;
      observe the changes of negative symptoms and cognitive function, and the incidence of adverse&#xD;
      reactions of acupuncture therapy, to explore the &quot;new&quot; auxiliary means for the treatment of&#xD;
      negative symptoms, to guide clinical individualization and accurate medical treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2019</primary_completion_date>
  <phase>Phase 4</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>the baseline</time_frame>
    <description>a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>the end of 12 weeks</time_frame>
    <description>a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Clinical Assessment Interview for Negative Symptoms (CAINS)</measure>
    <time_frame>the baseline</time_frame>
    <description>including CAINS and CAINS self-reported checklists</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Clinical Assessment Interview for Negative Symptoms (CAINS)</measure>
    <time_frame>the end of 12 weeks</time_frame>
    <description>including CAINS self-reported checklists</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Repeatable sets of neuropsychological state measurements (RBANS)</measure>
    <time_frame>the baseline</time_frame>
    <description>That allows us to measure cognitive impairment in patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Repeatable sets of neuropsychological state measurements (RBANS)</measure>
    <time_frame>the end of 12 weeks</time_frame>
    <description>That allows us to measure cognitive impairment in patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Temporal Experience of Pleasure Scale (TEPS)</measure>
    <time_frame>the baseline</time_frame>
    <description>That allows us to measure the experience of pleasure in patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Temporal Experience of Pleasure Scale (TEPS)</measure>
    <time_frame>the end of 12 weeks</time_frame>
    <description>That allows us to measure the change of experience of pleasure in patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acupuncture+Amisulpride</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amisulpride</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Amisulpride only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>acupuncture</intervention_name>
    <description>Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks. These patients were combined with acupuncture. Acupuncture points include:'Yintang', 'Shenting', 'Taiyang', 'Jingming', 'Zanzhu', 'Yuyao', 'Jiaosun', 'Baihui', 'Fengchi', 'Anmian'.</description>
    <arm_group_label>Acupuncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amisulpride</intervention_name>
    <description>Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks.</description>
    <arm_group_label>Acupuncture</arm_group_label>
    <arm_group_label>Amisulpride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The diagnosis of schizophrenia according to International classification&#xD;
             diagnosis-10(ICD-10)&#xD;
&#xD;
          -  patients at an age between 18～60 years old of Han nationality&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other psychiatric diagnoses&#xD;
&#xD;
          -  Suffering from serious physical disease and can not accept the treatment&#xD;
&#xD;
          -  Patients to be diagnosed according to ICD-10 for substance abused, development delayed&#xD;
&#xD;
          -  Inability to sign informed consent because of capacity due due to severe mental&#xD;
             illness, significant psychomotor agitation or slowness test completion&#xD;
&#xD;
          -  claustrophobic&#xD;
&#xD;
          -  metal implantation in vivo&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhenghui YI</last_name>
    <role>Principal Investigator</role>
    <affiliation>SHANGHAI MENTAL HEALTH CENTRE</affiliation>
  </overall_official>
  <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_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Schizophrenia ，acupuncture，Amisulpride</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>Amisulpride</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/NCT03802838
org study id: ZHYY-ZXYJHZX-2-201708
nct id: NCT03802838
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To explore the effects of combined traditional Chinese and Western medicine( Chinese
      acupuncture combined with Amisulpride Tablets) on negative symptoms, cognitive function and
      social function in patients with schizophrenia, and the side effects and safety of Chinese
      acupuncture combined with Amisulpride Tablets.
Our research hypothesis：1. Medically assisted Acupuncture in schizophrenia can improve
      negative symptoms；2. Drug assisted Acupuncture Therapy has better cognitive function in
      schizophrenic patients than single drug；3. Schizophrene with acupuncture have fewer and
      lighter adverse reactions。This study was carried out only in Shanghai Mental Health Center.
      It was a parallel randomized study.Schizophrene with negative symptoms were treated with
      atypical antipsychotic drug amisulpride, but still remained negative symptoms. Using the
      mature Chinese medicine therapy acupuncture auxiliary treatment, using the more reliable
      clinical evaluation method (the grader blind method: The raters were not sure which patients
      were the study group or the control group), compared with the single drug treatment, To
      observe the changes of negative symptoms and cognitive function, and the incidence of adverse
      reactions of acupuncture therapy, to explore the "new" auxiliary means for the treatment of
      negative symptoms, to guide clinical individualization and accurate medical treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: The Positive and Negative Syndrome Scale (PANSS)
time frame: the baseline
description: a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale
measure: The Positive and Negative Syndrome Scale (PANSS)
time frame: the end of 12 weeks
description: a 30-items, 7-point rating scale; the 7 rating points represent increasing levels of psychopathology: 1= absent, 2= minimal, 3= mild, 4 = moderate, 5= moderate-severe, 6= severe, 7= extreme; of the 16 items, 7 were chosen to constitute Positive Scale, 7 items for Negative Scale and the remaining 16 items for a General Psychopathology Scale
measure: The Clinical Assessment Interview for Negative Symptoms (CAINS)
time frame: the baseline
description: including CAINS and CAINS self-reported checklists
measure: The Clinical Assessment Interview for Negative Symptoms (CAINS)
time frame: the end of 12 weeks
description: including CAINS self-reported checklists
measure: Repeatable sets of neuropsychological state measurements (RBANS)
time frame: the baseline
description: That allows us to measure cognitive impairment in patients.
measure: Repeatable sets of neuropsychological state measurements (RBANS)
time frame: the end of 12 weeks
description: That allows us to measure cognitive impairment in patients.
measure: The Temporal Experience of Pleasure Scale (TEPS)
time frame: the baseline
description: That allows us to measure the experience of pleasure in patients.
measure: The Temporal Experience of Pleasure Scale (TEPS)
time frame: the end of 12 weeks
description: That allows us to measure the change of experience of pleasure in patients.
arm group label: Acupuncture
arm group type: Active Comparator
description: Acupuncture+Amisulpride
arm group label: Amisulpride
arm group type: Other
description: Amisulpride only.
intervention type: Device
intervention name: acupuncture
description: Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks. These patients were combined with acupuncture. Acupuncture points include:'Yintang', 'Shenting', 'Taiyang', 'Jingming', 'Zanzhu', 'Yuyao', 'Jiaosun', 'Baihui', 'Fengchi', 'Anmian'.
arm group label: Acupuncture
intervention type: Drug
intervention name: Amisulpride
description: Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks.
arm group label: Acupuncture
arm group label: Amisulpride
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Zhenghui YI
role: Principal Investigator
affiliation: SHANGHAI MENTAL HEALTH CENTRE
facility: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Amisulpride
sharing ipd: No