| Participants |
Inclusion criteria
Male or female participants Aged 18 to 65 years Primary DSM‐5 diagnosis of BPD confirmed by the SCID‐5‐PD at screening Participants who, in the investigator's judgement, 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 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 participants must also agree not to donate sperm from trial screening through 30 days after the last dose of IMP. Women who are breastfeeding or who have a positive pregnancy test result (or both) 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 MDD, PTSD, ADHD, panic disorder, or generalised 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. Participants currently in psychotherapy specifically used to target BPD symptoms at time of screening Participants who have had electroconvulsive treatment or transcranial magnetic stimulation Participants with a current diagnosis of substance or alcohol use disorder within 90 days prior to screening visit Participants who fulfil the following criteria related to suicide or suicidal ideation (or both) 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 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 hospitalisations due to suicidal behaviour. Note, participants who have engaged in non‐suicidal self‐injurious behaviour within the 90 days prior to screening or at day 0 are eligible, unless the behaviour is better described as an actual attempt, interrupted attempt, or aborted attempt according to C‐SSRS definition or investigator judgement (or both) and therefore exclusionary. Participants 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. Participants with hypothyroidism or hyperthyroidism or an abnormal result for free T4 at screening Participants who currently have clinically significant neurological, hepatic, renal, metabolic, haematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders Participants with uncontrolled hypertension, symptomatic hypotension, or orthostatic hypotension Participants with epilepsy or a history of seizures, except for a single seizure episode Participants who received brexpiprazole in any prior clinical trial or participants who have taken or are taking commercially available brexpiprazole (Rexulti®) Participants with a history of neuroleptic malignant syndrome, serotonin syndrome, or clinically significant tardive dyskinesia Participants with a history of true allergic response to more than 1 class of medication Participants who are currently either inpatient or partially hospitalised 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
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