Efficacy of Lurasidone in the Treatment of Agitation Associated With Acute Schizophrenia

Objectives: To evaluate the efficacy of lurasidone in reducing agitation in patients hospitalized for acute exacerbation of schizophrenia.
Methods: This analysis was performed on pooled data from five 6-week, double-blind, placebo-controlled studies in patients with schizophrenia who were randomized to fixed 40-160 mg once-daily doses of lurasidone. Efficacy assessments were PANSS total score and the PANSS Excited Component (PEC) subscore recorded on day 3/4 and day 7 in patients (n=773) experiencing clinically relevant levels of agitation (high agitation defined as a PEC score ≥14 at baseline). 
Results: In the high agitation group, treatment with lurasidone was associated with a significantly lower attrition rate compared with placebo (36.0% vs. 48.1%; p<0.01). Treatment with lurasidone vs. placebo was associated with significantly greater improvement in PANSS-EC scores at days 3/4 (-1.6 vs. -1.0; p<0.001), day 7 (-2.3 vs. -1.6; p<0.001), and at week 6 endpoint (-5.5 vs. -3.8; p<0.001). Treatment with lurasidone was also associated with significantly greater improvement in PANSS total scores at days 3/4 (-5.1 vs. -4.0; p<0.001), day 7 (-9.0 vs. -6.5; p<0.001), and at week 6 endpoint (-27.2 vs. -18.4; p<0.001). Higher endpoint responder rates (≥20% improvement in PANSS total) with lurasidone vs. placebo were observed in the high agitation group (64.3% vs. 43.4%; p<0.01).
Conclusions: Treatment with lurasidone significantly reduced agitation as early as day 3, with improvement maintained through week 6. Lurasidone also significantly improved both the PANSS total and CGI-S scores from day 7 onward in patients with high baseline agitation.