<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/NCT02248987</url>
  </required_header>
  <id_info>
    <org_study_id>3420130030</org_study_id>
    <nct_id>NCT02248987</nct_id>
  </id_info>
  <brief_title>Study on Abnormal Dopamine Synthesis and Connectivity According to the Antipsychotic Treatment Response in Schizophrenia</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>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity&#xD;
      according to the antipsychotic treatment response in schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging.</measure>
    <time_frame>within 2 weeks from enrollment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>resting state functional magnetic resonance imaging</measure>
    <time_frame>within 2 weeks from enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diffusion tensor imaging</measure>
    <time_frame>within 2 weeks from enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical measure including Positive and Negative Syndrome Scale</measure>
    <time_frame>within 2 weeks from enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neurocognitive function test</measure>
    <time_frame>within 2 weeks from enrollment</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Clozapine</arm_group_label>
    <description>stable patients treated with clozapine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Other antipsychotics</arm_group_label>
    <description>stable patients treated with risperidone or paliperidone or olanzapine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteer</arm_group_label>
    <description>healthy controls</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>patients treated with antipsychotics</intervention_name>
    <arm_group_label>Clozapine</arm_group_label>
    <arm_group_label>Healthy volunteer</arm_group_label>
    <arm_group_label>Other antipsychotics</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        1. Schizophrenia patients treated with clozapine&#xD;
&#xD;
          2. Schizophrenia patients treated with risperidone or paliperidone or olanzapine&#xD;
&#xD;
          3. Healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of schizophrenia&#xD;
&#xD;
          -  clinically stable state&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of previous head injury, epileptic disorder, other medical comorbidity&#xD;
&#xD;
          -  substance abuse/dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <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>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antipsychotic Agents</mesh_term>
  </intervention_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/NCT02248987
org study id: 3420130030
nct id: NCT02248987
lead sponsor: 
The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity
      according to the antipsychotic treatment response in schizophrenia.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Striatal [18F]-DOPA uptake measured using positron emission tomographic 18F-dopa imaging.
time frame: within 2 weeks from enrollment
measure: resting state functional magnetic resonance imaging
time frame: within 2 weeks from enrollment
measure: diffusion tensor imaging
time frame: within 2 weeks from enrollment
measure: clinical measure including Positive and Negative Syndrome Scale
time frame: within 2 weeks from enrollment
measure: neurocognitive function test
time frame: within 2 weeks from enrollment
arm group label: Clozapine
description: stable patients treated with clozapine
arm group label: Other antipsychotics
description: stable patients treated with risperidone or paliperidone or olanzapine
arm group label: Healthy volunteer
description: healthy controls
intervention type: Other
intervention name: patients treated with antipsychotics
arm group label: Clozapine
arm group label: Healthy volunteer
arm group label: Other antipsychotics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
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
mesh term: Antipsychotic Agents