<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/NCT04471454</url>
  </required_header>
  <id_info>
    <org_study_id>2020-03</org_study_id>
    <nct_id>NCT04471454</nct_id>
  </id_info>
  <brief_title>Verification of the Reliability and Validity of THINC-it Tool in Bipolar Depression</brief_title>
  <official_title>Verification of the Reliability and Validity of THINC-it Cognitive Test in the Assessment of Cognitive Impairment in Bipolar Depression</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>
      There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple,&#xD;
      fast and free cognitive assessment tool. It has good reliability and validity in patients&#xD;
      with depression, but its application in patients with bipolar depression is not clear. The&#xD;
      purpose of this study is to verify the reliability and validity of THINC-it cognitive test in&#xD;
      bipolar depression, and to further explore the difference of cognitive impairment between&#xD;
      attack and remission of bipolar depression, so as to provide empirical research basis for&#xD;
      clinical evaluation-based treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple,&#xD;
      fast and free cognitive assessment tool. It has good reliability and validity in patients&#xD;
      with depression, but its application in patients with bipolar depression is not clear.&#xD;
&#xD;
      This study includes three steps.&#xD;
&#xD;
        1. baseline: demographic data, sequential test THINC-it and standard test tools, clinical&#xD;
           scale evaluation, to verify the discriminant validity and parallel validity of THINC-it&#xD;
           in bipolar depression.&#xD;
&#xD;
        2. follow-up (1 week): 30-50 patients with stable bipolar depression were evaluated by&#xD;
           clinical scale and THINC-it test to verify the test-retest reliability of THINC-it in&#xD;
           bipolar depression.&#xD;
&#xD;
        3. follow-up (8 weeks): all patients with bipolar depression were evaluated by clinical&#xD;
           scale, THINC-it test, longitudinal comparison data, and the influencing factors of&#xD;
           cognitive impairment were analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Composite THINC-it Tool Score</measure>
    <time_frame>up to 8 week</time_frame>
    <description>The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CANTAB reaction time (RTI)</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>online computer test, RTI evaluates the response speed of movement and psychology, as well as activity time, reaction time, accurate value and error value of response, and calculates the time required to correctly evaluate the occurrence of stimuli in one location.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>1-back memory task (1-back)</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>the subjects' attention, memory, reaction speed and executive function were tested.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Digit Symbol Substitution Test (DSST)</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>participants in the digital symbol substitution test calculated the correct total number by matching symbols and numbers as soon as possible within 90 seconds according to the coding table.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trail Making Test B</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>he subjects calculated the completion time according to the cross-connection of numbers and letters. The higher the score, the more obvious the functional damage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sheehan Disability scale (SDS)</measure>
    <time_frame>Up to 8 week</time_frame>
    <description>Evaluation of the severity of overall functional impairment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAM-D</measure>
    <time_frame>Up to 8 week</time_frame>
    <description>Assess the state of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HAM-A</measure>
    <time_frame>Up to 8 week</time_frame>
    <description>Assessing anxiety state</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>Bipolar Depression</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Bipolar depression group: samples were collected from outpatients and inpatients of&#xD;
        Shanghai Mental Health Center and Shanghai Pudong New area Mental Health Center from&#xD;
        January 2020 to December 2020, who met the diagnostic criteria of DSM-5.&#xD;
&#xD;
        Healthy control group: the sample came from the social recruitment of healthy people who&#xD;
        met the criteria of the control group and matched in sex, age and education level. 100&#xD;
        cases were planned to be included in the group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Case group:&#xD;
&#xD;
               1. Participants in psychiatric outpatients and inpatients are able and willing to&#xD;
                  provide informed consent.&#xD;
&#xD;
        two。. The participants were male or female aged between 18 and 65, with junior high school&#xD;
        education or above.&#xD;
&#xD;
        3. According to DSM-5 criteria, participants were diagnosed with depressive episodes of&#xD;
        bipolar disorder.&#xD;
&#xD;
        4. The total score of Young's Mania scale ((YMRS)) of the participants was less than 5.&#xD;
&#xD;
        5. Subjects received stable mood stabilizers at least two weeks before the study visit,&#xD;
        such as SSRIs antidepressants.&#xD;
&#xD;
        6. The combination or use of supportive psychotherapy is allowed.&#xD;
&#xD;
        Control group:&#xD;
&#xD;
        1.it did not meet any of the diagnostic criteria of axis I in DSM-5 in the past or at&#xD;
        present.&#xD;
&#xD;
        2.18-65 years old, junior high school education or above. 3.have sufficient audio-visual&#xD;
        skills to complete the necessary examinations of the study.&#xD;
&#xD;
        4.Willing to participate in this study, and the informed consent form was signed by the&#xD;
        subjects.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current alcohol and / or substance use disorders.&#xD;
&#xD;
          2. Any drug that may affect cognitive function, such as psychotropic stimulants,&#xD;
             corticosteroids, and receptor blockers.&#xD;
&#xD;
          3. Benzodiazepines were used within 12 hours and alcohol consumption within 8 hours&#xD;
             before using the THINC-it cognitive test.&#xD;
&#xD;
          4. The patient has some serious physical conditions.&#xD;
&#xD;
          5. The patient received electroconvulsive therapy ((ECT)) in the past 6 months.&#xD;
&#xD;
          6. There are serious negative suicidal concepts and behaviors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Chen, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Mental Health Center IRB</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>August 2021</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>October 24, 2021</last_update_submitted>
  <last_update_submitted_qc>October 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bipolar Depression</keyword>
  <keyword>cognitive impairment</keyword>
  <keyword>THINC-it</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04471454
org study id: 2020-03
nct id: NCT04471454
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple,
      fast and free cognitive assessment tool. It has good reliability and validity in patients
      with depression, but its application in patients with bipolar depression is not clear. The
      purpose of this study is to verify the reliability and validity of THINC-it cognitive test in
      bipolar depression, and to further explore the difference of cognitive impairment between
      attack and remission of bipolar depression, so as to provide empirical research basis for
      clinical evaluation-based treatment.
There is some cognitive impairment in patients with bipolar depression. THINC-it is a simple,
      fast and free cognitive assessment tool. It has good reliability and validity in patients
      with depression, but its application in patients with bipolar depression is not clear.

      This study includes three steps.

        1. baseline: demographic data, sequential test THINC-it and standard test tools, clinical
           scale evaluation, to verify the discriminant validity and parallel validity of THINC-it
           in bipolar depression.

        2. follow-up (1 week): 30-50 patients with stable bipolar depression were evaluated by
           clinical scale and THINC-it test to verify the test-retest reliability of THINC-it in
           bipolar depression.

        3. follow-up (8 weeks): all patients with bipolar depression were evaluated by clinical
           scale, THINC-it test, longitudinal comparison data, and the influencing factors of
           cognitive impairment were analyzed.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Composite THINC-it Tool Score
time frame: up to 8 week
description: The composite THINC-it tool score is the integrated total score of results from performance on five sub-component cognitive tests of the THINC-it tool.
measure: CANTAB reaction time (RTI)
time frame: Up to 1 week
description: online computer test, RTI evaluates the response speed of movement and psychology, as well as activity time, reaction time, accurate value and error value of response, and calculates the time required to correctly evaluate the occurrence of stimuli in one location.
measure: 1-back memory task (1-back)
time frame: Up to 1 week
description: the subjects' attention, memory, reaction speed and executive function were tested.
measure: Digit Symbol Substitution Test (DSST)
time frame: Up to 1 week
description: participants in the digital symbol substitution test calculated the correct total number by matching symbols and numbers as soon as possible within 90 seconds according to the coding table.
measure: Trail Making Test B
time frame: Up to 1 week
description: he subjects calculated the completion time according to the cross-connection of numbers and letters. The higher the score, the more obvious the functional damage.
measure: Sheehan Disability scale (SDS)
time frame: Up to 8 week
description: Evaluation of the severity of overall functional impairment
measure: HAM-D
time frame: Up to 8 week
description: Assess the state of depression
measure: HAM-A
time frame: Up to 8 week
description: Assessing anxiety state
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jun Chen, M.D., Ph.D
role: Principal Investigator
affiliation: Shanghai Mental Health Center
facility: 
country: China
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Bipolar Disorder
sharing ipd: Undecided