Objective: To evaluate the effects of lurasidone on social functioning in schizophrenia over the course of a 6-week, double-blind, placebocontrolled study and a subsequent 12-week open-label extension study.
Methods: A total of 478 patients with schizophrenia (per DSM-IV-TR criteria) randomized to either lurasidone 40 mg/d (n = 245) or placebo (n = 233) in the initial 6-week double-blind study (initiated May 2016, completed November 2018) were included in the analysis. Longer-term changes were examined in a sample of 146 patients who received lurasidone, and 141 who received placebo, during the 6-week study and received flexibly dosed (40-80 mg/d) lurasidone during the 12-week extension phase. The 4-item Positive and Negative Syndrome Scale (PANSS) prosocial subscale was used to examine changes in social functioning.