Social and functional outcomes with two doses of aripiprazole lauroxil vs placebo in patients with schizophrenia: a post-hoc analysis of a 12-week phase 3 efficacy study

Abstract To assess the effect of the long-acting antipsychotic aripiprazole lauroxil (AL) on social and functional outcomes compared with placebo in patients with acute schizophrenia, a post-hoc analysis was conducted. Patients with acute schizophrenia were enrolled in a 12-week, double-blind, placebo-controlled efficacy trial, and randomized 1:1:1 to receive AL 441 mg, AL 882 mg, or placebo every 4 weeks. Changes in social functioning using the 6- and 4-item Positive and Negative Syndrome Scale (PANSS) Prosocial subscales were evaluated. The Personal and Social Performance (PSP) total score evaluated patients’ global improvement. Changes from baseline were analyzed using mixed-effect models repeat measurements. PANSS Prosocial subscale scores and PSP total score improved significantly with AL vs. placebo, without any dose-related difference in magnitude of response. Significant mean ± SE improvements in 6-item PANSS Prosocial scores from baseline to Day 85 were observed for both individual active treatment groups (e.g., AL 441 mg and AL 882 mg groups) vs. placebo. There were significant changes in PSP total score from baseline to Day 85 for both AL doses vs. placebo. This post-hoc analysis demonstrated a significant improvement in social functioning with AL vs. placebo, as assessed by the PANSS Prosocial subscale and PSP total score.