A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: Brexpiprazole
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brexpiprazole 2-3 Milligrams Per Day<br>Participants received brexpiprazole, 2-3 milligrams per day (mg/day) tablets, orally, up to Week 12 during the treatment phase. | Drug: Brexpiprazole<br>* Tablet<br>* Other names: Rexulti®;|
| Placebo Comparator: Placebo<br>Participants received brexpiprazole-matching placebo tablets, orally, up to Week 12 during the treatment phase. | Other: Placebo<br>* Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) total score | A clinician-administered scale with a total score range of 0 to 36. A higher score represents a higher severity of disease symptoms. | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Clinical Global Impression - Severity of Illness (CGI-S) score | An observer-rated scale with a total score range of 0 to 7. A higher score represents a worse outcome. | Up to 12 weeks | 
| Change from baseline in the Patient's Global Impression of Severity (PGI-S) for each trial visit during the double-blind treatment period | A 7-point single-item self-report scale for the patient to rate the severity of symptoms of BPD. A higher score denotes more severe symptoms. | Up to 12 weeks | 
| Patient's Global Impression of Change (PGI-C) Scale Score | A 7-point single-item self-report scale depicting a subject's rating of overall change in their condition since starting trial medication. With a higher score denoting a worse outcome. | Up to 12 weeks | 
| Clinical Global Impression - Improvement (CGI-I) Scale Score | An observer-rated scale with a total score of 0 to 7. A higher score represents a worse outcome. | Up to 12 weeks |