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Psych Congress  

Efficacy of Lurasidone in Patients With Schizophrenia With Prominent Positive Symptoms: A Pooled Analysis of Short-Term Placebo-Controlled Studies

Authors  
Steven Potkin, MD; Michael Tocco, PhD; Yongcai Mao, PhD; Josephine Cucchiaro, PhD; Andrei Pikalov, MD, PhD; Antony Loebel, MD
Sponsor  
Sunovion Pharmaceuticals Inc.

This poster was presented at the 29th Annual U.S. Psychiatric & Mental Health Congress, held October 21-24, 2016, in San Antonio, Texas.

Objective: To evaluate the efficacy of lurasidone in patients with schizophrenia who have prominent positive symptoms.
Methods: Data were pooled from 5 similarly designed, multiregional, randomized, double-blind, placebo-controlled, 6-week studies of fixed-dose lurasidone (40-160 mg/d) in adult patients with acute schizophrenia. Prominent positive symptoms were defined as baseline Positive and Negative Syndrome Scale (PANSS) positive subscale score > negative subscale score. Changes from baseline in PANSS total and positive subscale scores were evaluated using mixed-model repeated-measures analysis (MMRM).
Results: This analysis included 919 patients with and 613 patients without prominent positive symptoms. Based on change from baseline to week 6 in PANSS total score, effect sizes for lurasidone 40, 80, 120, and 160 mg/d were 0.60, 0.68, 0.51, and 1.02, respectively, for patients with prominent positive symptoms (all P<0.001) and 0.35, 0.38, 0.57, and 0.63, respectively, for patients without prominent positive symptoms (P<0.05 for 40 mg/d; all other P<0.001). For change from baseline to week 6 in PANSS positive subscale score, effect sizes for the lurasidone 40, 80, 120, and 160 mg/d dose groups were 0.42, 0.63, 0.51, and 1.31, respectively, for patients with prominent positive symptoms (P<0.01 for 40 mg/d, all other P<0.001) and 0.24, 0.55, 0.56, and 0.65, respectively, for patients without prominent positive symptoms (P=0.082 for 40 mg/d, all other P<0.001).
Conclusions: In patients with schizophrenia, lurasidone therapy was generally associated with medium to large treatment effect sizes. Larger effect sizes were observed in patients with prominent positive symptoms compared to patients without prominent positive symptoms.    

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