<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/NCT03292848</url>
  </required_header>
  <id_info>
    <org_study_id>331-201-00103</org_study_id>
    <nct_id>NCT03292848</nct_id>
  </id_info>
  <brief_title>Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to &lt;13 Years Old) With Central Nervous System Disorders</brief_title>
  <official_title>A Phase 1, Single-dose, Sequential Cohort, Nonrandomized Crossover Trial to Assess the Pharmacokinetics, Safety, and Tolerability of Oral Brexpiprazole in Children (6 to&lt; 13 Years Old) With Central Nervous System Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>H. Lundbeck A/S</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages&#xD;
      6 to &lt;13 years with CNS disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A US based nonrandomized, sequential cohort, crossover trial to assess pharmacokinetics,&#xD;
      safety and tolerability of brexpiprazole in children ages 6 to &lt;13 years with CNS disorders&#xD;
      who are receiving antipsychotic treatment for their medical condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">May 21, 2018</completion_date>
  <primary_completion_date type="Actual">May 21, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) [PK]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>The maximum plasma concentration of drug will be assessed for brexpiprazole and its major metabolite DM-3411.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under concentration-time curve (AUC) calculated from time zero to time t (AUCt) [PK]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>AUCt will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine average concentration of drug over time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC from time zero to infinity [PK]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>AUC infinity will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine total drug exposure over time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum plasma concentration (tmax) [PK]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>The amount of time that the maximum plasma concentration of drug will be assessed for plasma brexpiprazole and its major metabolite DM-3411</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal-phase elimination half-life (t½,z) [PK]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>t½,z will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine drug persistence in the body</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent clearance of drug from plasma after extravascular administration (CL/F) [PK]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>CL/F for brexpiprazole only</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment-Emergent Adverse Events (TEAES) [Safety]</measure>
    <time_frame>Up to 22 days or early termination with a 21 day follow-up period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical laboratory tests [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>Collect hematology, serum chemistry,and urinalysis will be assessed to determine the safety and tolerability of drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs observed and change from baseline data (systolic and diastolic blood pressure) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs observed and change from baseline data (heart rate) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs observed and change from baseline data (respiratory rate) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs observed and change from baseline data (body temperature) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-lead electrocardiogram (ECGs) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examinations (height) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>Height is measured in cm,and will be used to calculate Body Mass Index (BMI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examinations (weight) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>Weight is measured in kg, and will be used to calculate Body Mass Index (BMI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examinations- Body Mass Index (BMI) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>Body Mass Index (BMI) measured using height (cm) and weight (kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical examinations- review of body systems [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>Subject will be examined by site staff for any notable changes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Simpson-Angus Scale (SAS) rating scale [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>Will be used in analysis of Extrapyramidal Symptoms (EPS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormal Involuntary Movement Scale (AIMS) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>Will be used in analysis of Extrapyramidal Symptoms (EPS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barnes Akathisia Rating Scale (BARS) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
    <description>Will be used in analysis of Extrapyramidal Symptoms (EPS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]</measure>
    <time_frame>Up to 22 days or early termination</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>ADHD</condition>
  <condition>Autism</condition>
  <condition>Bipolar I Disorder</condition>
  <condition>Conduct Disorder</condition>
  <condition>Oppositional Defiant Disorder</condition>
  <arm_group>
    <arm_group_label>10 to &lt;13 Years of Age</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses will be administered with a washout period of 14 days between the first dose of 1.5 mg the second dose of 3 mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6 to &lt;10 Years of Age</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses will be administered with a washout period of 14 days between the first dose of 0.75 mg and the second dose of 1.5 mg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Brexpiprazole</intervention_name>
    <description>Tablet</description>
    <arm_group_label>10 to &lt;13 Years of Age</arm_group_label>
    <arm_group_label>6 to &lt;10 Years of Age</arm_group_label>
    <other_name>OPC-34712</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects between 6 and 12 years of age&#xD;
&#xD;
          -  Subjects with CNS disorders including, but not limited to, ADHD, autism spectrum&#xD;
             disorders, bipolar I disorder (subjects 10 to 12 years old only for bipolar), conduct&#xD;
             disorder, oppositional defiant disorder, or any psychotic disorder and who are&#xD;
             receiving antipsychotic treatment for their medical condition. Subjects' diagnoses&#xD;
             will be determined by the Diagnostic and Statistical Manual of Mental Disorders, 5th&#xD;
             Edition (DSM-5) criteria and confirmed at screening using the Kiddie Schedule for&#xD;
             Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).&#xD;
&#xD;
          -  Subjects must be considered psychiatrically/medically appropriate for participation in&#xD;
             a clinical trial in which they will receive two doses of an antipsychotic medication.&#xD;
&#xD;
          -  Subjects with good physical health, as determined by no clinically significant&#xD;
             deviation from normal for all of the following, prior to enrollment in the trial:&#xD;
&#xD;
               1. Medical history&#xD;
&#xD;
               2. Clinical laboratory determination&#xD;
&#xD;
               3. ECGs&#xD;
&#xD;
               4. Physical examinations&#xD;
&#xD;
          -  Subjects who are within the 5th to 95th percentile for gender-specific BMI for age&#xD;
             from the Centers for Disease Control and Prevention growth charts and weight at least&#xD;
             15 kg (approx. 33 lbs)&#xD;
&#xD;
          -  Ability to commit to remain fully abstinent or use 2 approved methods of birth control&#xD;
             during the trial for 21 (± 2) days following the last dose of IMP for sexually active&#xD;
             females of childbearing potential.&#xD;
&#xD;
          -  Ability, in the opinion of the PI, of the subject and the subject's legally acceptable&#xD;
             representative or caregiver(s) to understand the nature of the trial and follow&#xD;
             protocol requirements, including all of the following:&#xD;
&#xD;
               1. Comply with prescribed dosage regimens and tablet ingestion, as well as the&#xD;
                  discontinuation of prohibited concomitant medications&#xD;
&#xD;
               2. Reliably return for scheduled visits&#xD;
&#xD;
               3. To be reliably rated on assessment scales&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a clinical presentation or history that is consistent with delirium,&#xD;
             dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that&#xD;
             are better accounted for by another general medical condition(s) other than those&#xD;
             listed in the second inclusion criterion above, or direct effect of a substance (ie,&#xD;
             medication, illicit drug use, etc.).&#xD;
&#xD;
          -  Subjects with a history of at least mild intellectual disability as determined by IQ &lt;&#xD;
             70, clinical evidence, or a social or school history that is suggestive of&#xD;
             intellectual disability.&#xD;
&#xD;
          -  Subjects who have any of the following:&#xD;
&#xD;
               1. A significant risk of committing suicide based on history and the principal&#xD;
                  investigator's clinical judgment, or routine psychiatric status examination&#xD;
&#xD;
               2. Current suicidal behavior&#xD;
&#xD;
               3. Imminent risk of injury; active suicidal ideation&#xD;
&#xD;
               4. Any lifetime history of suicidal behavior detected by the Children's&#xD;
                  Baseline/Screening version of the C-SSRS.&#xD;
&#xD;
          -  Subjects with a lifetime history of a substance use disorder (as determined by the&#xD;
             DSM-5 criteria), or current substance misuse including alcohol and benzodiazepines,&#xD;
             but excluding caffeine and nicotine.&#xD;
&#xD;
          -  Subjects who currently have clinically significant neurological, hepatic, renal,&#xD;
             metabolic, hematological, immunological, cardiovascular, pulmonary, or&#xD;
             gastrointestinal disorders such as any history of myocardial infarction, congestive&#xD;
             heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic&#xD;
             hepatitis B or C. Medical conditions that are minor or well-controlled may be&#xD;
             considered acceptable if the condition does not expose the subject to an undue risk of&#xD;
             significant adverse event or interfere with assessments during the course of the&#xD;
             trial.&#xD;
&#xD;
          -  Subjects with insulin dependent diabetes mellitus (IDDM) are excluded. Subjects with&#xD;
             non-IDDM may be eligible for the trial if their condition is determined to be stable.&#xD;
&#xD;
          -  Subjects with epilepsy or a history of seizures (except for a single seizure episode,&#xD;
             for instance childhood febrile seizure or post traumatic) or a history of severe head&#xD;
             trauma or cerebrovascular disease (eg, stroke, transient ischemic attack, etc.).&#xD;
&#xD;
          -  Any major surgery within 30 days prior to the first dose of IMP.&#xD;
&#xD;
          -  Any history of significant bleeding or hemorrhagic tendencies.&#xD;
&#xD;
          -  Blood transfusions within 30 days prior to first dose of IMP.&#xD;
&#xD;
          -  Subjects with a positive drug screen for cocaine, marijuana (even if by prescription),&#xD;
             or other illicit drugs, or alcohol are excluded and may not be retested or rescreened.&#xD;
&#xD;
          -  Subjects who have supine or standing diastolic blood pressure, after resting for at&#xD;
             least 5 minutes, ≥ 95 mmHg.&#xD;
&#xD;
          -  Subjects who have had a dose of depot antipsychotics within 6 months of screening.&#xD;
&#xD;
          -  Consumption of alcohol or grapefruit, grapefruit juice, Seville oranges, or Seville&#xD;
             orange juice within 72 hours prior to the first dose of IMP and throughout the trial&#xD;
&#xD;
          -  Subjects who participated in a clinical trial and were exposed to IMP within the last&#xD;
             30 days prior to screening or who participated in more than 2 interventional clinical&#xD;
             trials within the past year.&#xD;
&#xD;
          -  Subjects with a history of neuroleptic malignant syndrome or hypersensitivity to&#xD;
             atypical antipsychotics.&#xD;
&#xD;
          -  Subjects with a history of true allergic (i.e. not intolerance) response to more than&#xD;
             one class of medications.&#xD;
&#xD;
          -  Subjects with a history of allergic reaction or a known or suspected sensitivity to&#xD;
             any substance that is contained in the IMP formula.&#xD;
&#xD;
          -  Subjects who do not tolerate venipuncture or have poor venous access that would cause&#xD;
             difficulty for collecting blood samples.&#xD;
&#xD;
          -  Prisoners or subjects who are compulsorily detained (e.g. juvenile detention,&#xD;
             court-mandated treatment) for any reason.&#xD;
&#xD;
          -  Inability to tolerate oral medication or swallow tablets.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Woodland International Research Group</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Woodland Research Northwest, LLC</name>
      <address>
        <city>Rogers</city>
        <state>Arkansas</state>
        <zip>72758</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Wellness dba Alliance for Research</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hope Clinical Research</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPS Research Company</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cutting Edge Research Group</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Trials of Texas, Inc.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Road Runner Research Ltd.</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspen Clinical Research</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84058</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>June 11, 2018</last_update_submitted>
  <last_update_submitted_qc>June 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CNS Disorders</keyword>
  <keyword>Brexpiprazole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Conduct Disorder</mesh_term>
    <mesh_term>Attention Deficit and Disruptive Behavior Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brexpiprazole</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/NCT03292848
org study id: 331-201-00103
nct id: NCT03292848
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages
      6 to <13 years with CNS disorders.
A US based nonrandomized, sequential cohort, crossover trial to assess pharmacokinetics,
      safety and tolerability of brexpiprazole in children ages 6 to <13 years with CNS disorders
      who are receiving antipsychotic treatment for their medical condition.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Plasma Concentration (Cmax) [PK]
time frame: Up to 22 days or early termination
description: The maximum plasma concentration of drug will be assessed for brexpiprazole and its major metabolite DM-3411.
measure: Area under concentration-time curve (AUC) calculated from time zero to time t (AUCt) [PK]
time frame: Up to 22 days or early termination
description: AUCt will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine average concentration of drug over time
measure: AUC from time zero to infinity [PK]
time frame: Up to 22 days or early termination
description: AUC infinity will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine total drug exposure over time
measure: Time of maximum plasma concentration (tmax) [PK]
time frame: Up to 22 days or early termination
description: The amount of time that the maximum plasma concentration of drug will be assessed for plasma brexpiprazole and its major metabolite DM-3411
measure: Terminal-phase elimination half-life (t½,z) [PK]
time frame: Up to 22 days or early termination
description: t½,z will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine drug persistence in the body
measure: Apparent clearance of drug from plasma after extravascular administration (CL/F) [PK]
time frame: Up to 22 days or early termination
description: CL/F for brexpiprazole only
measure: Treatment-Emergent Adverse Events (TEAES) [Safety]
time frame: Up to 22 days or early termination with a 21 day follow-up period
measure: Clinical laboratory tests [Safety]
time frame: Up to 22 days or early termination
description: Collect hematology, serum chemistry,and urinalysis will be assessed to determine the safety and tolerability of drug
measure: Vital signs observed and change from baseline data (systolic and diastolic blood pressure) [Safety]
time frame: Up to 22 days or early termination
measure: Vital signs observed and change from baseline data (heart rate) [Safety]
time frame: Up to 22 days or early termination
measure: Vital signs observed and change from baseline data (respiratory rate) [Safety]
time frame: Up to 22 days or early termination
measure: Vital signs observed and change from baseline data (body temperature) [Safety]
time frame: Up to 22 days or early termination
measure: 12-lead electrocardiogram (ECGs) [Safety]
time frame: Up to 22 days or early termination
measure: Physical examinations (height) [Safety]
time frame: Up to 22 days or early termination
description: Height is measured in cm,and will be used to calculate Body Mass Index (BMI)
measure: Physical examinations (weight) [Safety]
time frame: Up to 22 days or early termination
description: Weight is measured in kg, and will be used to calculate Body Mass Index (BMI)
measure: Physical examinations- Body Mass Index (BMI) [Safety]
time frame: Up to 22 days or early termination
description: Body Mass Index (BMI) measured using height (cm) and weight (kg)
measure: Physical examinations- review of body systems [Safety]
time frame: Up to 22 days or early termination
description: Subject will be examined by site staff for any notable changes
measure: Simpson-Angus Scale (SAS) rating scale [Safety]
time frame: Up to 22 days or early termination
description: Will be used in analysis of Extrapyramidal Symptoms (EPS)
measure: Abnormal Involuntary Movement Scale (AIMS) [Safety]
time frame: Up to 22 days or early termination
description: Will be used in analysis of Extrapyramidal Symptoms (EPS)
measure: Barnes Akathisia Rating Scale (BARS) [Safety]
time frame: Up to 22 days or early termination
description: Will be used in analysis of Extrapyramidal Symptoms (EPS)
measure: Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
time frame: Up to 22 days or early termination
arm group label: 10 to <13 Years of Age
arm group type: Experimental
description: Two doses will be administered with a washout period of 14 days between the first dose of 1.5 mg the second dose of 3 mg.
arm group label: 6 to <10 Years of Age
arm group type: Experimental
description: Two doses will be administered with a washout period of 14 days between the first dose of 0.75 mg and the second dose of 1.5 mg.
intervention type: Drug
intervention name: Brexpiprazole
description: Tablet
arm group label: 10 to <13 Years of Age
arm group label: 6 to <10 Years of Age
other name: OPC-34712
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nervous System Diseases
mesh term: Central Nervous System Diseases
mesh term: Conduct Disorder
mesh term: Attention Deficit and Disruptive Behavior Disorders
mesh term: Brexpiprazole