A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder

• Status: Active, not recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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 subjects diagnosed with BPD to provide a pharmacological treatment for BPD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Brexpiprazole

Criteria

Inclusion Criteria:

• Male or female subjects, ages 18 to 65, inclusive, at the time of informed consent

• Subjects with a primary DSM-5 diagnosis of BPD confirmed by the SCID-5-PD at screening.

• At screening and Day 0, subjects must have a total score ≥ 12 on the ZAN-BPD scale.

• Subjects who, in the investigator's judgment, require treatment with a medication for BPD.

• Subjects 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 IMP. Consensual sexual activity that cannot biologically result in pregnancy may not be subject to required birth control methods, following discussion with the medical monitor. Male subjects 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.

• Subjects with a concurrent DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Also, subjects with a concurrent diagnosis of bipolar I disorder, bipolar II disorder, delirium, dementia, amnesia, eating disorder, antisocial personality disorder, or other cognitive disorders. Subjects with MDD, PTSD, ADHD, panic disorder, or generalized anxiety can be included if symptoms have been stable, these disorders are not the primary focus of treatment and changes in any treatment for these disorders would not likely be required for the duration of the trial.

• Subjects currently in psychotherapy specifically used to target BPD symptoms at time of screening.

• Subjects who have had electroconvulsive treatment or transcranial magnetic stimulation.

• Subjects with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit.

• Subjects who fulfill the following criteria related to suicide and/or suicidal ideation are excluded:

• Subjects 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 subjects with a response of "yes" on the C-SSRS Suicidal Ideation Item 5, OR

• Subjects with a response of "yes" on the C-SSRS Suicidal Behavior Items, OR

• Subjects who have had 3 suicide attempts, OR,

• Subjects who have had 3 or more hospitalizations due to suicidal behavior. Note that subjects who have engaged in non-suicidal self-injurious behavior within the 90 days prior to screening or at Day 0 are eligible, unless the behavior is better described as an actual attempt, interrupted attempt, or aborted attempt according to C-SSRS definition and/or investigator judgment and therefore exclusionary.

Subjects with a response of "yes" on the C-SSRS Suicidal Ideation Item 4 within the 90 days prior to screening or at Day 0 may be included following discussion with a medical monitor.

• Subjects with hypothyroidism or hyperthyroidism or an abnormal result for free T4 at screening.

• Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders.

• Subjects with uncontrolled hypertension, symptomatic hypotension, or orthostatic hypotension.

• Subjects with epilepsy or a history of seizures, except for a single seizure episode.

• Subjects who received brexpiprazole in any prior clinical trial or subjects who have taken or are taking commercially available brexpiprazole (Rexulti®).

• Subjects with a history of neuroleptic malignant syndrome, serotonin syndrome, or clinically significant tardive dyskinesia.

• Subjects with a history of true allergic response to more than 1 class of medication.

• Subjects who are currently either inpatient or partially hospitalized.

• Subjects 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.