<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/NCT03839251</url>
  </required_header>
  <id_info>
    <org_study_id>CUH 2018-02-011-005</org_study_id>
    <nct_id>NCT03839251</nct_id>
  </id_info>
  <brief_title>Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients</brief_title>
  <official_title>Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Chonbuk National University Hospital</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to investigate the effectiveness of Aripiprazole long-acting&#xD;
      injection in recent onset and chronic schizophrenia patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate the effectiveness of Aripiprazole long-acting&#xD;
      injection in recent onset and chronic schizophrenia patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 22, 2020</primary_completion_date>
  <phase>Phase 4</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>Change from Baseline PSP(Personal and Social Performance scale) at 12weeks</measure>
    <time_frame>12weeks</time_frame>
    <description>PSP(Personal and Social Performance scale) was measured in baseline and 12week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline PSP(Personal and Social Performance scale) at 24weeks</measure>
    <time_frame>24weeks</time_frame>
    <description>PSP(Personal and Social Performance scale) was measured in baseline and 24week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)</measure>
    <time_frame>baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks</time_frame>
    <description>Clinical global impression-schizophrenia(CGI-S)&#xD;
There are Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity in the Clinical global impression-schizophrenia(CGI-S). minimum of each items(Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity) is 1, Maximum is 7. The higher number is worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy Assessment by ERT(Emotional Recognition Test)</measure>
    <time_frame>baseline, 24weeks</time_frame>
    <description>Emotional Recognition Test(ERT)&#xD;
minimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)</measure>
    <time_frame>baseline, 12weeks, 24weeks</time_frame>
    <description>Positive and Negative Syndrome Scale(PANSS)&#xD;
There are Positive Scale, Negative Scale and General Psychopathology Scale in the PANSS(Positive and Negative Syndrome Scale). minimum of each items(Positive Scale, Negative Scale and General Psychopathology Scale) is 1, Maximum is 7. The higher number is worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy Assessment by self rating scale</measure>
    <time_frame>baseline, 12weeks, 24weeks</time_frame>
    <description>Subjective Wellbeing under Neuroleptics(SWN-K)&#xD;
SWN-K(Subjective Wellbeing under Neuroleptics) consists of 20 questions. The minimum score for each question is zero and the maximum score is five. The reverse scoring questions include 1,4,6,9,10,11,12,14,16,17. The total score of the whole item is obtained, and the lower the score, the worse the subjective well-being.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment by Simpson-Angus Scale(SAS)</measure>
    <time_frame>baseline, 12weeks, 24weeks</time_frame>
    <description>Simpson-Angus Scale(SAS)&#xD;
minimum of each items(Gait, Arm Dropping, Shoulder Shaking, Elbow Rigidity, Fixation of Position or Wrist Rigidity, Leg Pendulousness, Head Dropping, Glabella Tap, Tremor, Salivation) in the SAS(Simpson-Angus Scale) is 0, Maximum is 4. minimum of total scores in the SAS(Simpson-Angus Scale) is 0, Maximum is 40. The higher number is worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment by Barnes Akathisia Rating Scale(BARS)</measure>
    <time_frame>baseline, 12weeks, 24weeks</time_frame>
    <description>Barnes Akathisia Rating Scale(BARS)&#xD;
minimum of each items(Objective, Subjective, Distress related to restlessness) in the BAS(Barnes Akathisia Rating Scale) is 0, Maximum is 3. Minimum of Global clinical assessment of akathisia in the BARS is 0, Maximum is 5. The higher number is worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)</measure>
    <time_frame>baseline, 12weeks, 24weeks</time_frame>
    <description>Abnormal Involuntary Movement Scale(AIMS)&#xD;
minimum of each items in the AIMS(Abnormal Involuntary Movement Scale) is 0, Maximum is 4. The higher number is worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Assessment by self report scale</measure>
    <time_frame>baseline, 12weeks, 24weeks</time_frame>
    <description>Visual Analogue Scale(VAS)&#xD;
minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">82</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>abilify maintena</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>aripiprazole 400mg or 300mg, IM, Once a month</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>abilify maintena</intervention_name>
    <description>aripiprazole 400mg or 300mg, IM, Once a month</description>
    <arm_group_label>abilify maintena</arm_group_label>
    <other_name>aripiprazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients diagnosed with schizophrenia according to DSM-5 diagnostic standards&#xD;
&#xD;
          -  men and women aged 19 and under 60&#xD;
&#xD;
          -  a person who is being given an atypical antipsychotic.&#xD;
&#xD;
          -  Patients should be able to reasonably cooperate with the questionnaire to be used for&#xD;
             the study&#xD;
&#xD;
          -  a person who fully understands the purpose of the study and signs the consent&#xD;
&#xD;
          -  stable outpatient before screening without changing the volume of antipsychotics for&#xD;
             at least two weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a person who has a serious and unstable physical condition either now or in the past&#xD;
&#xD;
          -  A fertile woman who is currently pregnant or breastfeeding, or who is either unwilling&#xD;
             or unable to use acceptable contraception until the clinical trial is complete.&#xD;
&#xD;
          -  a person suffering from severe drug allergies or complex and severe drug reactions&#xD;
&#xD;
          -  Patients who have taken clozapine in the last 60 days&#xD;
&#xD;
          -  subjects showing significant risk of suicide or significant risk of violent behavior&#xD;
             based on past history or investigator's judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Young-chul Chung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychiatry, Inje University Haeundae Paik Hospital</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Psychiatry, Kyungpook National University Hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Psychiatry, Yeungnam University Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Psychiatry, Chonnam National University Medical School</name>
      <address>
        <city>Gwangju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Psychiatry, Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>January 25, 2021</last_update_submitted>
  <last_update_submitted_qc>January 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Young Chul Chung</investigator_full_name>
    <investigator_title>Professor of Psychiatry</investigator_title>
  </responsible_party>
  <keyword>aripiprazole</keyword>
  <keyword>long-acting injection</keyword>
  <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>Aripiprazole</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/NCT03839251
org study id: CUH 2018-02-011-005
nct id: NCT03839251
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the study is to investigate the effectiveness of Aripiprazole long-acting
      injection in recent onset and chronic schizophrenia patients
The aim of this study is to investigate the effectiveness of Aripiprazole long-acting
      injection in recent onset and chronic schizophrenia patients
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline PSP(Personal and Social Performance scale) at 12weeks
time frame: 12weeks
description: PSP(Personal and Social Performance scale) was measured in baseline and 12week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
measure: Change from Baseline PSP(Personal and Social Performance scale) at 24weeks
time frame: 24weeks
description: PSP(Personal and Social Performance scale) was measured in baseline and 24week. Minimum of PSP(Personal and Social Performance Scale) is 1, maximum is 100. The lower number is worse outcome.
measure: Efficacy Assessment by CGI-S(Clinical global impression-schizophrenia)
time frame: baseline, 4weeks, 8weeks, 12weeks, 16weeks, 20weeks, 24weeks
description: Clinical global impression-schizophrenia(CGI-S)
There are Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity in the Clinical global impression-schizophrenia(CGI-S). minimum of each items(Positive Symptoms, Negative Symptoms, Depressive Symptoms, Cognitive Symptoms and Overall severity) is 1, Maximum is 7. The higher number is worse outcome.
measure: Efficacy Assessment by ERT(Emotional Recognition Test)
time frame: baseline, 24weeks
description: Emotional Recognition Test(ERT)
minimum of ERT(Emotional Recognition Test) total score is 0, Maximum is 54. The lower number is worse outcome.
measure: Efficacy Assessment by PANSS(Positive and Negative Syndrome Scale)
time frame: baseline, 12weeks, 24weeks
description: Positive and Negative Syndrome Scale(PANSS)
There are Positive Scale, Negative Scale and General Psychopathology Scale in the PANSS(Positive and Negative Syndrome Scale). minimum of each items(Positive Scale, Negative Scale and General Psychopathology Scale) is 1, Maximum is 7. The higher number is worse outcome.
measure: Efficacy Assessment by self rating scale
time frame: baseline, 12weeks, 24weeks
description: Subjective Wellbeing under Neuroleptics(SWN-K)
SWN-K(Subjective Wellbeing under Neuroleptics) consists of 20 questions. The minimum score for each question is zero and the maximum score is five. The reverse scoring questions include 1,4,6,9,10,11,12,14,16,17. The total score of the whole item is obtained, and the lower the score, the worse the subjective well-being.
measure: Safety Assessment by Simpson-Angus Scale(SAS)
time frame: baseline, 12weeks, 24weeks
description: Simpson-Angus Scale(SAS)
minimum of each items(Gait, Arm Dropping, Shoulder Shaking, Elbow Rigidity, Fixation of Position or Wrist Rigidity, Leg Pendulousness, Head Dropping, Glabella Tap, Tremor, Salivation) in the SAS(Simpson-Angus Scale) is 0, Maximum is 4. minimum of total scores in the SAS(Simpson-Angus Scale) is 0, Maximum is 40. The higher number is worse outcome.
measure: Safety Assessment by Barnes Akathisia Rating Scale(BARS)
time frame: baseline, 12weeks, 24weeks
description: Barnes Akathisia Rating Scale(BARS)
minimum of each items(Objective, Subjective, Distress related to restlessness) in the BAS(Barnes Akathisia Rating Scale) is 0, Maximum is 3. Minimum of Global clinical assessment of akathisia in the BARS is 0, Maximum is 5. The higher number is worse outcome.
measure: Safety Assessment by Abnormal Involuntary Movement Scale(AIMS)
time frame: baseline, 12weeks, 24weeks
description: Abnormal Involuntary Movement Scale(AIMS)
minimum of each items in the AIMS(Abnormal Involuntary Movement Scale) is 0, Maximum is 4. The higher number is worse outcome.
measure: Safety Assessment by self report scale
time frame: baseline, 12weeks, 24weeks
description: Visual Analogue Scale(VAS)
minimum of VAS(Visual Analogue Scale) is 0, Maximum is 10. The higher number is worse outcome.
arm group label: abilify maintena
arm group type: Other
description: aripiprazole 400mg or 300mg, IM, Once a month
intervention type: Drug
intervention name: abilify maintena
description: aripiprazole 400mg or 300mg, IM, Once a month
arm group label: abilify maintena
other name: aripiprazole
criteria: 
gender: All
minimum age: 19 Years
maximum age: 60 Years
healthy volunteers: No
last name: Young-chul Chung, MD
role: Principal Investigator
affiliation: Chonbuk National University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Young Chul Chung
investigator title: Professor of Psychiatry
mesh term: Schizophrenia
mesh term: Aripiprazole