Summary:
This will be a 12-week, multicenter, randomized, double-blind, placebo-controlled, 2-arm trial evaluating the efficacy and safety of brexpiprazole treatment in adult subjects with BPD. Subjects will be randomized (1:1) to 2-3 mg/day brexpiprazole (n = 120) or placebo (n = 120).
Criteria:- The trial population will consist of male and female outpatients, aged 18 to 65 years, inclusive.
- Subjects will have a BPD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition(DSM-5) and confirmed by a valid diagnostic instrument (Structured Clinical Interview for DSM-5 Personality Disorders [SCID-5-PD]) and a total score of ≥ 12 on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) at the screening visit and at Day 0.
- In addition, a score of ≥ 2 in at least 2 of the following 4 ZAN-BPD subscale items will be required at screening and Day 0:
1. “inappropriate, intense anger or difficulty controlling anger” (hereafter referred to as inappropriate anger),
2. "transient stress-related paranoid ideation or severe dissociative symptoms” (paranoid ideation)
3. "affective instability due to a marked reactivity of mood” (affective instability), and
4. "impulsivity in at least other two areas that are potentially self-damaging” (impulsivity).
Qualified Participants May Receive:
Compensation for time and travel.