<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/NCT03772951</url>
  </required_header>
  <id_info>
    <org_study_id>HKQ201813</org_study_id>
    <nct_id>NCT03772951</nct_id>
  </id_info>
  <brief_title>The Efficacy of Computerized Cognitive Remediation Therapy for Chronic Schizophrenia</brief_title>
  <official_title>The Efficacy for Execution Function and Genetic Mechanism of Computerized Cognitive Remediation Therapy for Chronic 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>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>
      The study group received antipsychotic drugs combined with Computerized Cognitive Remediation&#xD;
      Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received&#xD;
      antipsychotic drugs. For a total of 12 weeks. Brain Derived Neurotrophic Factor (BDNF) and&#xD;
      Tropomyosin-related kinase B (Trk B) genes in peripheral blood were detected in both groups&#xD;
      before and after treatment. Clinical symptoms and executive function assessment were&#xD;
      performed in both groups before and after treatment. The relevance of genes and their effects&#xD;
      on downstream protein expression levels led to a molecular genetic mechanism for the efficacy&#xD;
      of Computerized Cognitive Remediation Therapy (CCRT) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Among the cognitive disorders of chronic schizophrenia, the most reported is the executive&#xD;
      dysfunction of the prefrontal lobe. There is increasing evidence that Computerized Cognitive&#xD;
      Remediation Therapy (CCRT) has a significant improvement in the implementation of&#xD;
      schizophrenia, but the specific mechanism is unknown. Therefore, this study plans to select&#xD;
      154 patients with chronic schizophrenia who were hospitalized for a long time. They were&#xD;
      randomly divided into two groups. The study group received antipsychotic drugs combined with&#xD;
      Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time.&#xD;
      The control group only received antipsychotic drugs. For a total of 12 weeks. brain-derived&#xD;
      neurotrophic factor (BDNF) and tyrosine receptor kinase B(TRK-B) genes in peripheral blood&#xD;
      were detected in both groups before and after treatment. Clinical symptoms and executive&#xD;
      function assessment were performed in both groups before and after treatment. The relevance&#xD;
      of genes and their effects on downstream protein expression levels led to a molecular genetic&#xD;
      mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 2021</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 score of Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>the baseline</time_frame>
    <description>The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome. The subscales are summed to compute a total score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The score of Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>the end of 12 week</time_frame>
    <description>The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome.The subscales are summed to compute a total score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment</measure>
    <time_frame>the baseline</time_frame>
    <description>The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment</measure>
    <time_frame>the end of 12 week</time_frame>
    <description>The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment</measure>
    <time_frame>the baseline</time_frame>
    <description>The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment</measure>
    <time_frame>the end of 12 week</time_frame>
    <description>The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Cognitive Remediation Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The study group received antipsychotic drugs Clozapine combined with Computerized Cognitive Remediation Therapy for 4 times/week for 45 minutes each time. For a total of 12 weeks. Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clozapine</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive Remediation Therapy</intervention_name>
    <description>Through computer information technology, using error-free, procedural learning, speech enhancement and a series of targeted computer programmatic cognitive correction tasks, patients can gradually improve problem solving and information processing capabilities, thereby improving their recognition function.</description>
    <arm_group_label>Cognitive Remediation Therapy</arm_group_label>
    <other_name>CCRT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clozapine</intervention_name>
    <description>the course of disease is more than 2 years, the condition is stable for more than one month</description>
    <arm_group_label>Clozapine</arm_group_label>
    <arm_group_label>Cognitive Remediation Therapy</arm_group_label>
    <other_name>CLZ</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-45 years old, Han nationality, male or female;&#xD;
&#xD;
          2. Comply with the American Diagnostic Criteria for Mental Disorder (DSM-V) diagnostic&#xD;
             criteria for &quot;schizophrenia&quot;;&#xD;
&#xD;
          3. The course of the disease and continued treatment with antipsychotic drugs for &gt; 2&#xD;
             years, stable for at least one month;&#xD;
&#xD;
          4. Positive NegativeSyndrome Scale (PANSS) &lt; 70 points;&#xD;
&#xD;
          5. intelligence quotient (IQ)&gt;80;&#xD;
&#xD;
          6. Cultural, social and educational backgrounds are sufficient to understand informed&#xD;
             consent and research content.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Concomitant diagnosis in addition to Diagnostic and Statistical Manual of Mental&#xD;
             Disorders-V other than schizophrenia;&#xD;
&#xD;
          2. Central nervous system organic diseases;&#xD;
&#xD;
          3. There are alcohol or other substances dependent or abused in the past two months,&#xD;
             causing significant social and cognitive impairment;&#xD;
&#xD;
          4. In the past year, there have been major life events such as widowhood;&#xD;
&#xD;
          5. Those who have serious suicide attempts (the third item of the (Hamilton Depression&#xD;
             Scale-17,HAMD-17) scale &quot;suicide&quot; ≥ 3 points);&#xD;
&#xD;
          6. The current patient's severe unstable physical disease;&#xD;
&#xD;
          7. pregnant women and lactating women;&#xD;
&#xD;
          8. Those who have received modified electroconvulsive therapy (MECT) and repetitive&#xD;
             Transcranial Magnetic Stimulation (rTMS) treatment in the past month;&#xD;
&#xD;
          9. Those who have been ineffective for more than 3 months of systemic psychotherapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>tao shen, professor</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Huangpu District Health and Wellness Committee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Huangpu District Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>20000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>October 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 19, 2021</last_update_submitted>
  <last_update_submitted_qc>December 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</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>Clozapine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 5, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03772951/Prot_SAP_ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03772951
org study id: HKQ201813
nct id: NCT03772951
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study group received antipsychotic drugs combined with Computerized Cognitive Remediation
      Therapy (CCRT) for 4 times/week for 45 minutes each time. The control group only received
      antipsychotic drugs. For a total of 12 weeks. Brain Derived Neurotrophic Factor (BDNF) and
      Tropomyosin-related kinase B (Trk B) genes in peripheral blood were detected in both groups
      before and after treatment. Clinical symptoms and executive function assessment were
      performed in both groups before and after treatment. The relevance of genes and their effects
      on downstream protein expression levels led to a molecular genetic mechanism for the efficacy
      of Computerized Cognitive Remediation Therapy (CCRT) .
Among the cognitive disorders of chronic schizophrenia, the most reported is the executive
      dysfunction of the prefrontal lobe. There is increasing evidence that Computerized Cognitive
      Remediation Therapy (CCRT) has a significant improvement in the implementation of
      schizophrenia, but the specific mechanism is unknown. Therefore, this study plans to select
      154 patients with chronic schizophrenia who were hospitalized for a long time. They were
      randomly divided into two groups. The study group received antipsychotic drugs combined with
      Computerized Cognitive Remediation Therapy (CCRT) for 4 times/week for 45 minutes each time.
      The control group only received antipsychotic drugs. For a total of 12 weeks. brain-derived
      neurotrophic factor (BDNF) and tyrosine receptor kinase B(TRK-B) genes in peripheral blood
      were detected in both groups before and after treatment. Clinical symptoms and executive
      function assessment were performed in both groups before and after treatment. The relevance
      of genes and their effects on downstream protein expression levels led to a molecular genetic
      mechanism for the efficacy of Computerized Cognitive Remediation Therapy (CCRT).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: The score of Positive and Negative Syndrome Scale (PANSS)
time frame: the baseline
description: The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome. The subscales are summed to compute a total score.
measure: The score of Positive and Negative Syndrome Scale (PANSS)
time frame: the end of 12 week
description: The score of Positive and Negative Syndrome Scale (PANSS) ranges from 19-133 and will be administered to assess the effectiveness of treatment. Do higher values represent a worse outcome.The subscales are summed to compute a total score.
measure: The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
time frame: the baseline
description: The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
measure: The concentration of Brain Derived Neurotrophic Factor (BDNF) used to assess the effectiveness of treatment
time frame: the end of 12 week
description: The Concentration of Brain Derived Neurotrophic Factor (BDNF) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
measure: The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment
time frame: the baseline
description: The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
measure: The concentration of tyrosine receptor kinase B(TRK-B) used to assess the effectiveness of treatment
time frame: the end of 12 week
description: The Concentration of tyrosine receptor kinase B(TRK-B) will be administered to assess the effectiveness of treatment. Do higher values represent a better outcome.
arm group label: Cognitive Remediation Therapy
arm group type: Active Comparator
description: The study group received antipsychotic drugs Clozapine combined with Computerized Cognitive Remediation Therapy for 4 times/week for 45 minutes each time. For a total of 12 weeks. Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.
arm group label: Clozapine
arm group type: Placebo Comparator
description: Clozapine, dosage, dosage form, and frequency :300~600 mg/d; po; duration: 12 week.
intervention type: Other
intervention name: Cognitive Remediation Therapy
description: Through computer information technology, using error-free, procedural learning, speech enhancement and a series of targeted computer programmatic cognitive correction tasks, patients can gradually improve problem solving and information processing capabilities, thereby improving their recognition function.
arm group label: Cognitive Remediation Therapy
other name: CCRT
intervention type: Drug
intervention name: Clozapine
description: the course of disease is more than 2 years, the condition is stable for more than one month
arm group label: Clozapine
arm group label: Cognitive Remediation Therapy
other name: CLZ
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: tao shen, professor
role: Study Director
affiliation: Shanghai Huangpu District Health and Wellness Committee
facility: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Clozapine
sharing ipd: No
provided document: 