Clinical Trial 42919

share

Berlin, NJ 08009


Study 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.


Study is Available At:

Hassman Research Institute
175 Cross Keys Rd
Berlin, NJ 08009
View Clinic Location

 


If you or someone you care for is interested in participating in this clinical trial and lives within 50 miles of the clinic, please complete the form below and click 'I Am Interested In This Study'

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.