<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/NCT01660880</url>
  </required_header>
  <id_info>
    <org_study_id>C-1205-094-410</org_study_id>
    <secondary_id>A070001</secondary_id>
    <nct_id>NCT01660880</nct_id>
  </id_info>
  <brief_title>Validation of Receptor Occupancy Simulation</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  To estimate dopamine receptor occupancy by aripiprazole using computer simulation&#xD;
&#xD;
        -  To measure dopamine receptor occupancy by aripiprazole in patients treated with the&#xD;
           antipsychotics&#xD;
&#xD;
        -  To validate the simulation result by comparing the receptor occupancy from the&#xD;
           simulation with that from the patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dopamine receptor occupancy</measure>
    <time_frame>72 hrs after the last administration</time_frame>
    <description>Measured using 11C-raclopride positron emission tomography</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hamilton rating scale for depression</measure>
    <time_frame>Baseline and 72 hours after the last administration</time_frame>
    <description>HAM-D score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barnes akathisia scale</measure>
    <time_frame>Baseline and 72 hours after the last administration</time_frame>
    <description>BAS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormal involuntary movement scale</measure>
    <time_frame>Baseline and 72 hours after the last administration</time_frame>
    <description>AIMS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simpson-Angus scale</measure>
    <time_frame>Baseline and 72 hours after the last administration</time_frame>
    <description>SAS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction questionnaire for medication</measure>
    <time_frame>Baseline and 72 hours after the last administration</time_frame>
    <description>TSQM score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication satisfaction questionnaire</measure>
    <time_frame>Baseline and 72 hours after the last administration</time_frame>
    <description>MSQ score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>N-back task</measure>
    <time_frame>Baseline and 72 hours after the last administration</time_frame>
    <description>To measure the change in working memory performance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolactin level</measure>
    <time_frame>Baseline and 72 hours after the last administration</time_frame>
    <description>To explore the effect of receptor occupancy on the blood prolactin level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dopamine receptor occupancy</measure>
    <time_frame>3 hrs after the last administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dopamine receptor occupancy</measure>
    <time_frame>24 hrs after the last administration</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Dopamine Receptor Occupancy</condition>
  <condition>Medication Satisfaction</condition>
  <condition>Prolactin Level</condition>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>aripiprazole</arm_group_label>
    <description>Patient group who is treated with aripiprazole</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with schizophrenia who is in the steady sate of antipsychotic treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of schizophrenia&#xD;
&#xD;
          -  treated with aripiprazole or risperidone&#xD;
&#xD;
          -  no change in dose of antipsychotics for at least 6 weeks&#xD;
&#xD;
          -  total PANSS score should be below 80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other psychiatric disorders rather than schizophrenia&#xD;
&#xD;
          -  history of head trauma&#xD;
&#xD;
          -  positive in urine hCG&#xD;
&#xD;
          -  on antidepressant, anticholinergics or mood stabilizer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Soo Kwon, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jun Soo Kwon</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <!-- 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/NCT01660880
org study id: C-1205-094-410
secondary id: A070001
nct id: NCT01660880
lead sponsor: 
has dmc: No
-  To estimate dopamine receptor occupancy by aripiprazole using computer simulation

        -  To measure dopamine receptor occupancy by aripiprazole in patients treated with the
           antipsychotics

        -  To validate the simulation result by comparing the receptor occupancy from the
           simulation with that from the patients
observational model: Case-Only
time perspective: Cross-Sectional
measure: Dopamine receptor occupancy
time frame: 72 hrs after the last administration
description: Measured using 11C-raclopride positron emission tomography
measure: Hamilton rating scale for depression
time frame: Baseline and 72 hours after the last administration
description: HAM-D score
measure: Barnes akathisia scale
time frame: Baseline and 72 hours after the last administration
description: BAS score
measure: Abnormal involuntary movement scale
time frame: Baseline and 72 hours after the last administration
description: AIMS score
measure: Simpson-Angus scale
time frame: Baseline and 72 hours after the last administration
description: SAS score
measure: Treatment satisfaction questionnaire for medication
time frame: Baseline and 72 hours after the last administration
description: TSQM score
measure: Medication satisfaction questionnaire
time frame: Baseline and 72 hours after the last administration
description: MSQ score
measure: N-back task
time frame: Baseline and 72 hours after the last administration
description: To measure the change in working memory performance
measure: Prolactin level
time frame: Baseline and 72 hours after the last administration
description: To explore the effect of receptor occupancy on the blood prolactin level
measure: Dopamine receptor occupancy
time frame: 3 hrs after the last administration
measure: Dopamine receptor occupancy
time frame: 24 hrs after the last administration
arm group label: aripiprazole
description: Patient group who is treated with aripiprazole
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: No
last name: Jun Soo Kwon, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jun Soo Kwon
investigator title: Professor
mesh term: Schizophrenia