A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

Sponsor ID
331-201-00242
Clinicaltrials.gov ID
NCT04100096
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-201-00242
Trial Details
Subscribe for updates
Age
18 - 65 Years
Therapeutic Area
  • Borderline Personality Disorder
    • Sex
    Female & Male
    Trial Dates
    Oct 2019 - Jun 2021
    Healthy Volunteers
    No
    • Male or female participants, ages 18 to 65, inclusive, at the time of informed consent
    • Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of BPD confirmed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) at screening.
    • At screening and Day 0, participants must have a total score ≥ 12 on the Zanarini Rating Scale for BPD (ZAN-BPD) scale.
    • Participants who, in the investigator's judgment, require treatment with a medication for BPD.
    • Participants willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
    • Sexually active males or females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP). Consensual sexual activity that cannot biologically result in pregnancy may not be participant to required birth control methods, following discussion with the medical monitor. Male participants must also agree not to donate sperm from trial screening through 30 days after the last dose of IMP.
    • Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
    • Participants with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, participants with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders.
    • Participants with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
    • Participants who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:
    • Participants who have a significant risk of committing violent acts, serious self-harm, or suicide based on history or routine psychiatric status examination, or those who are homicidal or considered to be a high risk to others, or participants with a response of "yes" on the Columbia-suicide severity rating scale (C-SSRS) Suicidal Ideation Item 5, OR
    • Participants with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR
    • Participants who have had 3 suicide attempts, OR,
    • Participants who have had 3 or more hospitalizations due to suicidal behavior.
    • Participants who received brexpiprazole in any prior clinical trial or participants who have taken or are taking commercially available brexpiprazole (Rexulti®).
    • Participants who are currently either inpatient or partially hospitalized.
    • Participants who participated in a clinical trial within 90 days prior to screening or who participated in more than 2 clinical trials within a year prior to screening.

    Study Summary

    There are currently no pharmacological treatments approved to treat borderline personality disorder (BPD). This trial will be conducted to evaluate the efficacy and safety of brexpiprazole for the treatment of participants diagnosed with BPD to provide a pharmacological treatment for BPD.

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    332
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Male or female participants, ages 18 to 65, inclusive, at the time of informed consent
    • * Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of BPD confirmed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) at screening.

    Exclusion Criteria

    • * Sexually active males or females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP). Consensual sexual activity that cannot biologically result in pregnancy may not be participant to required birth control methods, following discussion with the medical monitor. Male participants must also agree not to donate sperm from trial screening through 30 days after the last dose of IMP.
    • * Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female participants, ages 18 to 65, inclusive, at the time of informed consent
    • Participants with a primary Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis of BPD confirmed by the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD) at screening.
    • At screening and Day 0, participants must have a total score ≥ 12 on the Zanarini Rating Scale for BPD (ZAN-BPD) scale.
    • Participants who, in the investigator's judgment, require treatment with a medication for BPD.
    • Participants willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
    Exclusion Criteria:
    • Sexually active males or females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP). Consensual sexual activity that cannot biologically result in pregnancy may not be participant to required birth control methods, following discussion with the medical monitor. Male participants must also agree not to donate sperm from trial screening through 30 days after the last dose of IMP.
    • Women who are breastfeeding and/or who have a positive pregnancy test result prior to receiving IMP.
    • Participants with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, participants with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders.
    • Participants with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.
    • Participants who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:
    • Participants who have a significant risk of committing violent acts, serious self-harm, or suicide based on history or routine psychiatric status examination, or those who are homicidal or considered to be a high risk to others, or participants with a response of "yes" on the Columbia-suicide severity rating scale (C-SSRS) Suicidal Ideation Item 5, OR
    • Participants with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR
    • Participants who have had 3 suicide attempts, OR,
    • Participants who have had 3 or more hospitalizations due to suicidal behavior.
    • Participants who received brexpiprazole in any prior clinical trial or participants who have taken or are taking commercially available brexpiprazole (Rexulti®).
    • Participants who are currently either inpatient or partially hospitalized.
    • Participants who participated in a clinical trial within 90 days prior to screening or who participated in more than 2 clinical trials within a year prior to screening.

    Study Documents

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

    Locations

    Location
    Status
    Location
    Pillar Clinical Research
    Bentonville, Arkansas, United States, 72712
    Status
    N/A
    Location
    CI Trials
    Bellflower, California, United States, 90706
    Status
    N/A
    Location
    Care Access Research Beverly Hills
    Beverly Hills, California, United States, 90212
    Status
    N/A
    Location
    OM Research LLC
    Lancaster, California, United States, 93534
    Status
    N/A
    Location
    CalNeuro Research Group
    Los Angeles, California, United States, 90024
    Status
    N/A
    Location
    Excell Research
    Oceanside, California, United States, 92056
    Status
    N/A
    Showing {first} - {last} of {total} Results

    © 2026 Otsuka America Pharmaceutical, Inc.

    All rights reserved.

    January 2026 01US25EUC0489

    We defy limitation,

    so that others can too.

    Follow Us
    OAPI and OPDC Locations

    508 Carnegie Center Dr,

    Princeton, NJ 08540, United States

    Phone +1 609-524-6788

    2440 Research Blvd,

    Rockville, MD 20850, United States

    Phone +1 301-424-9055

    3956 Point Eden Way

    Hayward, CA 94545, United States

    Phone +1 800-562-3974