A Trial of Multiple‑doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Sponsor ID
031-201-00181
Clinicaltrials.gov ID
NCT04030143
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
031-201-00181
Trial Details
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Age
18 - 64 Years
Therapeutic Area
  • Schizophrenia
  • Bipolar Disorder
    • Sex
    Female & Male
    Trial Dates
    Aug 2019 - Jul 2020
    Healthy Volunteers
    No
    • A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
    • Body mass index of 18 to 35 kilograms per meter square (kg/m\^2).
    • On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.
    • Participants who have:
    • Met DSM-5 criteria for substance use disorder within the past 180 days.
    • A positive drug screen for drugs of abuse
    • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening.
    • Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
    • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
    • Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
    • Participants currently in an acute relapse of schizophrenia.
    • Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder.
    • Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
    • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
    • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies.
    • Participants deemed intolerant of receiving injections.
    • Participants who have had electroconvulsive therapy within 2 months of administration of IMP.

    Study Summary

    The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.

    Additional Study Details

    Phase
    Phase 1/Phase 2
    Study Drug
    Drug: Aripiprazole
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    266
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
    • * Body mass index of 18 to 35 kilograms per meter square (kg/m\^2).

    Exclusion Criteria

    • * Participants who have:
    • * Met DSM-5 criteria for substance use disorder within the past 180 days.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
    • Body mass index of 18 to 35 kilograms per meter square (kg/m\^2).
    • On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.
    Exclusion Criteria:
    • Participants who have:
    • Met DSM-5 criteria for substance use disorder within the past 180 days.
    • A positive drug screen for drugs of abuse
    • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening.
    • Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
    • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
    • Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
    • Participants currently in an acute relapse of schizophrenia.
    • Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder.
    • Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
    • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
    • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies.
    • Participants deemed intolerant of receiving injections.
    • Participants who have had electroconvulsive therapy within 2 months of administration of IMP.

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    Woodland International Research Group
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    Woodland International Research Group
    Rogers, Arkansas, United States, 72758
    Status
    N/A
    Location
    CITrials - Bellflower
    Bellflower, California, United States, 90706
    Status
    N/A
    Location
    Collaborative Neuroscience Network
    Garden Grove, California, United States, 92845
    Status
    N/A
    Location
    California Clinical Trials Medical Group
    Glendale, California, United States, 91206
    Status
    N/A
    Location
    Synergy Research Centers
    Lemon Grove, California, United States, 91945
    Status
    N/A
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