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A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
Study Identifier:
331-201-00242
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
Results Availables
Study Protocol
Available Language: English
Statistical Analysis Plan
Available Language: English
Study Details
Medical Condition
- Borderline Personality Disorder
Study Drug
- Drug: Brexpiprazole
Date
Oct 2019 - Jun 2021
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
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.
Protocol 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.
Study 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
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© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.
July 2025 01US25EUC0279
Requirements information
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.