<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/NCT03287505</url>
  </required_header>
  <id_info>
    <org_study_id>031-403-00050</org_study_id>
    <nct_id>NCT03287505</nct_id>
  </id_info>
  <brief_title>Aripiprazole IM Depot for Chinese Patients With Schizophrenia</brief_title>
  <official_title>Evaluation of Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation by Single Administration in Chinese Patients With Schizophrenia: a Single-center, Uncontrolled, Open -Label Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Beijing Research Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka Beijing Research Institute</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM&#xD;
      Depot formulation at doses of 300 and 400mg in patients with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, a single-center, single-dose, single-administration trial will be carried out&#xD;
      in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of&#xD;
      Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of&#xD;
      single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24&#xD;
      patients with oral tolerance of this drug.&#xD;
&#xD;
      In this study, the washout period before administration is designed as a 35-day duration&#xD;
      before administration of the investigational drug (aripiprazoleIM Depot), screening period a&#xD;
      4-week duration (28 days) before administration of the investigational drug, observation&#xD;
      period after administration a 20-week duration after administration of the investigational&#xD;
      drug and hospital stay a minimum 35-day duration after administration of the investigational&#xD;
      drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 23, 2017</start_date>
  <completion_date type="Actual">November 8, 2019</completion_date>
  <primary_completion_date type="Actual">November 8, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of Maximum Concentration</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC0-∞</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent clearance after extravascular administration</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital Signs</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Examination</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Positive and Negative Symptoms Scale (PANSS)</measure>
    <time_frame>up to 20 weeks</time_frame>
    <description>To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Abilify IM Depot 300mg by once</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abilify IM Depot 400mg by once</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aripiprazole IM Depot</intervention_name>
    <description>administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.</description>
    <arm_group_label>Abilify IM Depot 300mg by once</arm_group_label>
    <arm_group_label>Abilify IM Depot 400mg by once</arm_group_label>
    <other_name>ABILIFY MAINTENA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects, and their legal representatives(or their guardian ), who have signed the&#xD;
             informed consent form(ICF);&#xD;
&#xD;
          2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10,&#xD;
             295.20,295.90 , 295.60);&#xD;
&#xD;
          3. subjects, both male and female, who are at age between 18 and 64 (also including 18&#xD;
             and 64 years of age) at time of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have other psychiatric disorders than schizophrenia based on diagnostic&#xD;
             criteria of DSM-IV-TR;&#xD;
&#xD;
          2. Score of Positive and Negative Syndrome Scale (PANSS): ≥120;&#xD;
&#xD;
          3. Patients with a complication or a history of diabetic mellitus;&#xD;
&#xD;
          4. Subjects who are alcoholemia overdependent of drug, or have drug abuse history;&#xD;
&#xD;
        Other protocol-defined inclusion and exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tao Jiang, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Anding Hospital of Capital Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Anding Hospital of Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100088</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>May 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>December 24, 2020</last_update_submitted>
  <last_update_submitted_qc>December 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Aripiprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03287505
org study id: 031-403-00050
nct id: NCT03287505
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study assess pharmacokinetics and safety of single-administration of Aripiprazole IM
      Depot formulation at doses of 300 and 400mg in patients with schizophrenia.
In this study, a single-center, single-dose, single-administration trial will be carried out
      in patients with schizophrenia diagnosed pursuant to The Diagnostic and Statistical Manual of
      Mental Disorders (DSM-IV-TR), to evaluate pharmacokinetics and safety of
      single-administration aripiprazole IM Depot (300/400 mg) after its administration in 24
      patients with oral tolerance of this drug.

      In this study, the washout period before administration is designed as a 35-day duration
      before administration of the investigational drug (aripiprazoleIM Depot), screening period a
      4-week duration (28 days) before administration of the investigational drug, observation
      period after administration a 20-week duration after administration of the investigational
      drug and hospital stay a minimum 35-day duration after administration of the investigational
      drug.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Plasma Concentration
time frame: up to 20 weeks
description: To assess the maximum Plasma Concentration (Cmax) of aripiprazole and its main metabolite OPC-14857
measure: Time of Maximum Concentration
time frame: up to 20 weeks
description: To assess the time of Maximum Concentration (tmax) of aripiprazole and its main metabolite OPC-14857
measure: AUC0-∞
time frame: up to 20 weeks
description: To assess the area under the curve for period of medication, from 0 till infinity (AUC0-∞) of aripiprazole and its main metabolite OPC-14857
measure: Apparent clearance after extravascular administration
time frame: up to 20 weeks
description: To assess the Apparent clearance after extravascular administration (CL/F) of aripiprazole
measure: Adverse Events
time frame: up to 20 weeks
description: Adverse events will be examined by frequency, severity, seriousness, discontinuation, and relationship to treatment.
measure: Vital Signs
time frame: up to 20 weeks
description: Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for vital signs
measure: Laboratory Examination
time frame: up to 20 weeks
description: Mean change from baseline and the incidence of potentially clinically relevant abnormal values will be calculated for routine laboratory tests (including prolactin).
measure: Positive and Negative Symptoms Scale (PANSS)
time frame: up to 20 weeks
description: To evaluate the change of Positive and Negative Symptoms Scale (PANSS) from baseline.
arm group label: Abilify IM Depot 300mg by once
arm group type: Experimental
description: 300 mg dose group: single-administration of Aripiprazole IM Depot (300 mg) in 12 subjects;
arm group label: Abilify IM Depot 400mg by once
arm group type: Experimental
description: 400 mg dose group: single-administration of Aripiprazole IM Depot (400 mg) in 12 subjects.
intervention type: Drug
intervention name: Aripiprazole IM Depot
description: administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.
arm group label: Abilify IM Depot 300mg by once
arm group label: Abilify IM Depot 400mg by once
other name: ABILIFY MAINTENA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: No
last name: Tao Jiang, Master
role: Principal Investigator
affiliation: Beijing Anding Hospital of Capital Medical University
facility: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Aripiprazole
sharing ipd: No