<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/NCT03019887</url>
  </required_header>
  <id_info>
    <org_study_id>673</org_study_id>
    <nct_id>NCT03019887</nct_id>
  </id_info>
  <brief_title>Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction</brief_title>
  <official_title>Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Juntendo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Juntendo University</source>
  <brief_summary>
    <textblock>
      To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than&#xD;
      1000mg/day and to evaluate relationship between relapse and cognitive function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The&#xD;
      dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was&#xD;
      discontinued if the subjects relapsed. The differences in baseline cognitive function were&#xD;
      analyzed between the patients with no relapse and relapse groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Relapse</measure>
    <time_frame>One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.</time_frame>
    <description>The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">139</enrollment>
  <condition>Schizophrenia Relapse</condition>
  <arm_group>
    <arm_group_label>reduction group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine</intervention_name>
    <arm_group_label>reduction group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inpatients with a diagnosis of schizophrenia, and&#xD;
&#xD;
          -  those in the chronic phase receiving mean daily antipsychotic doses exceeding 1000-mg&#xD;
             chlorpromazine eq./day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  mental retardation,&#xD;
&#xD;
          -  substance abuse or dependence,&#xD;
&#xD;
          -  a history of major head trauma,&#xD;
&#xD;
          -  serious medical or neurological disorders, or&#xD;
&#xD;
          -  depot antipsychotic injections within the previous 3 months and electroconvulsive&#xD;
             therapy within the previous 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Takahashi Tadashi</last_name>
    <role>Study Chair</role>
    <affiliation>Okada hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mikiro Saito</last_name>
    <role>Study Chair</role>
    <affiliation>Okada hospital</affiliation>
  </overall_official>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>January 19, 2017</results_first_submitted>
  <results_first_submitted_qc>August 11, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2021</results_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Juntendo University</investigator_affiliation>
    <investigator_full_name>Ryota Ataniya</investigator_full_name>
    <investigator_title>Clinician, graduate student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methotrimeprazine</mesh_term>
    <mesh_term>Haloperidol</mesh_term>
    <mesh_term>Olanzapine</mesh_term>
    <mesh_term>Risperidone</mesh_term>
    <mesh_term>Aripiprazole</mesh_term>
    <mesh_term>Quetiapine Fumarate</mesh_term>
    <mesh_term>Paliperidone Palmitate</mesh_term>
    <mesh_term>Haloperidol decanoate</mesh_term>
    <mesh_term>Perphenazine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dose Reduction</title>
          <description>patients who reduced dose of antipsychotics</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="130"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reduction Group</title>
          <description>Group of patients with schizophrenia undergoing high-dose therapy (&gt;1000-mg chlorpromazine eq./day) We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="130"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.5" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Relapse</title>
        <description>The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage.</description>
        <time_frame>One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.</time_frame>
        <population>patients with schizophrenia taking more than 1000 mg / day of antipsychotics, reduce their dose to less than 1000 mg</population>
        <group_list>
          <group group_id="O1">
            <title>Dose Reduction</title>
            <description>patients who reduced dose of antipsychotics</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Relapse</title>
          <description>The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage.</description>
          <population>patients with schizophrenia taking more than 1000 mg / day of antipsychotics, reduce their dose to less than 1000 mg</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Dose Reduction</title>
          <description>patients who reduced dose of antipsychotics</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>increase in the total PANSS score from baseline</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>increase in total DIEPSS score</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="130"/>
              </event>
              <event>
                <sub_title>violent behavior</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="130"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Ryota Ataniya</name_or_title>
      <organization>Okada hospital</organization>
      <phone>+81-4-7124-6151</phone>
      <email>ryotaataniya@pbt.nir.jp</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03019887
org study id: 673
nct id: NCT03019887
lead sponsor: 
To reduce antipsychotics to under 1000mg in patients with schizophrenia taking more than
      1000mg/day and to evaluate relationship between relapse and cognitive function.
We attempted to reduce the dose of antipsychotics to ≤1000-mg chlorpromazine eq./day. The
      dose was gradually reduced at a rate of ≤50-mg chlorpromazine eq./week, and the reduction was
      discontinued if the subjects relapsed. The differences in baseline cognitive function were
      analyzed between the patients with no relapse and relapse groups.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Relapse
time frame: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.
description: The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage.
arm group label: reduction group
arm group type: Experimental
description: dose reduction of antipsychotics at a rate not exceeding 50mg chlorpromazine equivalent/week
intervention type: Drug
intervention name: reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine
arm group label: reduction group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Takahashi Tadashi
role: Study Chair
affiliation: Okada hospital
last name: Mikiro Saito
role: Study Chair
affiliation: Okada hospital
responsible party type: Principal Investigator
investigator affiliation: Juntendo University
investigator full name: Ryota Ataniya
investigator title: Clinician, graduate student
mesh term: Recurrence
mesh term: Schizophrenia
mesh term: Methotrimeprazine
mesh term: Haloperidol
mesh term: Olanzapine
mesh term: Risperidone
mesh term: Aripiprazole
mesh term: Quetiapine Fumarate
mesh term: Paliperidone Palmitate
mesh term: Haloperidol decanoate
mesh term: Perphenazine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 