Efficacy of lurasidone on anxiety symptoms in patients with schizophrenia: A pooled post hoc analysis of five randomized, placebo-controlled trials.

Aim: Comorbid anxiety disorders and their symptoms are common in schizophrenia and may occur before a relapse. The aim of this post hoc analysis is to investigate the efficacy of lurasidone on comorbid anxiety symptoms in patients with schizophrenia. Methods: Data were pooled from five Phase 3 randomized, double-blind, placebo-controlled 6-week trials of lurasidone treatment of schizophrenia, focusing on the 40 and 80 mg doses compared with placebo. Subgroup analyses were performed in two subgroups: severe (baseline Positive and Negative Syndrome Scale [PANSS] G2 anxiety score ≥ 4) and non-severe anxiety (baseline PANSS G2 score < 4). Results: In the severe anxiety group, both the 40 and 80 mg doses of lurasidone significantly reduced PANSS G2 score from Weeks 2 to 6 compared to placebo. In patients not receiving concomitant anxiolytics, significant improvement in the PANSS G2 score was observed at Week 6 for lurasidone 40 mg compared to placebo. In both lurasidone dose groups, PANSS total and subscale scores were significantly reduced at Week 6 compared to placebo. For baseline-to-Week-6 change scores, the PANSS G2 score and PANSS positive subscale score showed a moderate correlation. There were no new AEs of concern for lurasidone in this pooled analysis. Conclusion: The results suggest treatment with 40 or 80 mg/day of lurasidone improves anxiety symptoms in schizophrenia patients with moderate to severe anxiety, at least in part, through a direct effect, and this effect was demonstrated by lurasidone monotherapy, without the use of concomitant anxiolytics.