Agitation is a common presentation among patients hospitalized for an acute exacerbation of schizophrenia. Rapid and effective control of agitation is an important early treatment goal.

The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in reducing agitation in patients with an acute exacerbation of schizophrenia.

The analysis was performed on pooled data from 5 six-week, placebo-controlled trials in the subgroup of patients with an acute exacerbation of schizophrenia who met (n=773), or did not meet (n=754), criteria) for agitation (PANSS-Excited Component [EC] score ≥14 at baseline, Citrome, J Clin Psych 2007;68:1876-1885). Patients were randomized to fixed once-daily doses of lurasidone (40-160 mg).

The mean baseline PANSS-EC scores were similar for lurasidone vs. placebo in the high (16.7 vs. 16.8) and low (10.9 vs. 10.7) agitation subgroups. In the high agitation subgroup, treatment with lurasidone (vs. placebo) was associated with significantly greater improvement in PANSS-EC scores at days 3/4 (-2.0 vs. -1.3; p<0.001) and day 7 (-2.6 vs. -1.8; p<0.001). At week 6 endpoint, improvement on lurasidone vs. placebo was greater in the high vs. low agitation groups on the PANSS-EC score (effect size, 0.43 vs. 0.31), and comparable on the PANSS total score (effect size, 0.57 vs. 0.58).

In this pooled post-hoc analysis, treatment with lurasidone significantly reduced agitation by day 3/4 in patients hospitalized with an acute exacerbation of schizophrenia. The magnitude of improvement at week 6 was similar in both the high and low agitation groups.