Efficacy and safety of asenapine in Asian patients with an acute exacerbation of schizophrenia: a multicentre, randomized, double-blind, 6-week, placebo-controlled study.

Toshihiko Kinoshita,Ya-Mei Bai,Nobuyuki Oshima,Mutsuo Miyake,Jong-Hoon Kim

doi:10.1007/s00213-016-4295-9

Abstract

RationaleAsenapine is a second generation anti-psychotic approved in the USA in 2009 for the treatment of schizophrenia, but its efficacy has not been proven in Asian patients.ObjectivesThe objectives of this study are to evaluate the efficacy and tolerability of asenapine in Asian patients experiencing an acute exacerbation of schizophrenia.MethodsIn this prospective, double-blind study, patients in Japan, Korea, and Taiwan were randomized (1:1:1) to asenapine 5 mg twice daily (bid), 10 mg bid or placebo for 6 weeks after a 3- to 7-day washout/screening period. The primary endpoint was the mean change in the positive and negative syndrome scale (PANSS) total score from baseline to day 42/treatment end.ResultsOf the 532 participants randomized, 530 received treatment. The primary endpoint was significantly greater with asenapine 5 and 10 mg bid than with placebo (−12.24 and −14.17 vs. −0.95; p < 0.0001). The results of secondary endpoints including PANSS negative subscale scores and PANSS responders at the end of treatment supported the results of the primary endpoint. There were no significant differences in the incidence of treatment-emergent adverse events reported with asenapine 5 and 10 mg bid and placebo (84.6, 80.7, and 81.6 %). There was a mean (± standard deviation) change in weight of −1.76 ± 2.45 kg for placebo, +0.42 ± 2.65 kg for asenapine 5 mg bid, and +0.81 ± 2.89 kg for asenapine 10 mg bid group.ConclusionsAsenapine was effective and generally well tolerated when used for the treatment of acute exacerbations of schizophrenia in Asian patients.

Highlights

Schizophrenia is a complex psychiatric disorder associated with variable degrees of functional impairment and social disability (Lublin et al 2005; Tandon et al 2009)
The incidence of withdrawal due to lack of efficacy was lower for participants receiving asenapine 5 mg bid (7.4 % of treated participants) or 10 mg bid (5.0 %) than for those receiving placebo (15.5 %)
Asenapine 5 and 10 mg bid was effective in controlling both positive and negative symptoms, providing statistically significant improvements from baseline in positive and negative syndrome scale (PANSS) positive and negative scores compared with placebo, as well as significant improvements in general scores and PANSS Marder 5 factor scores

Summary

Introduction

Schizophrenia is a complex psychiatric disorder associated with variable degrees of functional impairment and social disability (Lublin et al 2005; Tandon et al 2009). It is a chronic relapsing disorder, with recurrent exacerbations of positive symptoms against a background of persistent negative symptoms, cognitive dysfunction, and depressive symptoms (Lublin et al 2005; Tandon et al 2009). Second generation anti-psychotics have differing levels of risk for weight gain and hyperprolactinemia (De Hert et al 2012; Kane 2011; Tandon et al 2010), which

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