A Double-blind, Placebo-controlled Study of Lumateperone in the Treatment of Borderline Personality Disorder.

Abstract

Objectives: Borderline personality disorder (BPD) is associated with psychosocial dysfunction 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. The aim of this study was to evaluate the safety and efficacy of lumateperone in adults with BPD.

Methods: Sixty adults with BPD were recruited for a randomized, double-blind, placebo-controlled study. Participants received 8-week treatment with lumateperone (42 mg/day) or identical 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 analyzed using a linear mixed-effects regression model that included terms for treatment group, time, and treatment-by-time interaction.

Results: There was no significant interaction between treatment and time on the ZAN-BPD scale at week 8. Lumateperone was generally well tolerated. Secondary measures did not result in statistically significant differences from placebo.

Conclusions: Lumateperone did not appear to reduce BPD symptoms compared with placebo. These findings also need to be viewed cautiously given the small sample size, large drop-out rate, and robust placebo response.