Abstract
BackgroundBorderline personality disorder (BPD) is associated with impaired quality of life and has a number of untoward public health associations. There is no established first-line pharmacological treatment for BPD, and available options are not suitable for all individuals.AimsTo evaluate Brexpiprazole, which has effects on the dopaminergic and serotonergic systems, for the reduction of BPD symptoms.MethodEighty adults with BPD were recruited for a randomized, double-blind, placebo-controlled study. Participants received 12-week treatment with brexpiprazole (1 mg/day for 1 week, then increasing to 2 mg/day) or placebo in a parallel design. The primary efficacy outcome measure was the clinician-rated Zanarini Rating Scale for Borderline Personality Disorder (“ZAN-BPD”). Safety data were collected. Effects of active versus placebo treatment were characterized using linear repeated measures models.ResultsThere was a significant interaction between treatment and time on the ZAN-BPD scale (p=0.0031), solely due to differentiation specifically at week 12. Brexpiprazole was generally well tolerated. Secondary measures did not result in statistically significant differences from placebo.DiscussionBrexpiprazole appears to have some possible effect on BPD symptoms but further studies are needed due to significant effects being evident specifically at the final time point. These findings also need to be viewed cautiously given the small sample size, large drop-out rate, and robust placebo response.
Highlights
Borderline personality disorder is associated with impaired quality of life and has a number of untoward public health associations
There was a significant interaction between treatment and time on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-Borderline personality disorder (BPD)) scale (P = 0.0031), solely because of differentiation at week 12
Brexpiprazole appears to have some possible effect on borderline personality disorder symptoms, but further studies are needed because of the significant effects evident, at the final time point
Summary
Eighty adults with borderline personality disorder were recruited for a randomised, double-blind placebo-controlled study. Eighty individuals aged 18–65 years (mean age 39.7 ± 11.6; n = 45 women [56.3%]) with a current established diagnosis of BPD (see below for assessment procedures) were recruited from clinic and local advertisements for a 13-week, randomised, double-blind placebo-controlled study in which brexpiprazole or placebo was administered in a 1:1 fashion. Inclusion criteria for the study were the following: aged 18–65 years, primary diagnosis of BPD, a total score of at least 9 on the clinician-rated Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) at study entry, and the ability to understand and sign the consent form. The exclusion criteria were as follows: unstable medical illness; schizophrenia or bipolar disorder; an active substance use disorder; current pregnancy or lactation, or inadequate contraception in women of childbearing potential; a suicide attempt within the 6 months before the baseline visit or significant risk of suicide (in the opinion of the investigator, defined as a ‘yes’ to suicidal ideation questions 4 or 5, or answering ‘yes’ to suicidal behaviour on the Columbia Suicide Severity Rating Scale within the past 6 months); illicit substance use based on urine toxicology screening (excluding marijuana); initiation of psychological interventions within 3 months of screening; use of any new psychotropic medication started within the past 3 months before study initiation; previous treatment with brexpiprazole; and cognitive impairment that might interfere with the capacity to understand and self-administer medication or provide written informed consent
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
