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Psych Congress  

Relapse Prevention and Remission During 12 Months of Double-blind Treatment With Lurasidone or Quetiapine XR in Patients With Schizophrenia

Antony Loebel, MD
Josephine Cucchiaro, PhD
Jane Xu, PhD
Kaushik Sarma, MD
Andrei Pikalov, MD, PhD
John Kane, MD
Sunovion Pharmaceuticals Inc.

Objective: To evaluate the efficacy of lurasidone (LUR) vs. quetiapine XR (QXR) in preventing relapse and achieving remission in schizophrenic patients following response to 6 weeks of treatment. Methods: This double-blind study, utilizing a noninferiority design, evaluated the prevention of relapse following 12 months of treatment with LUR (40-160 mg/day), compared with QXR (200-800 mg/day). Outpatients with an acute exacerbation of schizophrenia who had completed 6 weeks of double-blind, placebo-controlled, treatment with either LUR (80 mg/day or 160 mg/day) or QXR (600 mg/day) were included. The primary a priori efficacy comparison was between subjects treated with lurasidone (n=139) or QXR (n=79) who were clinical responders after acute treatment. Results: Twelve months of treatment with lurasidone was associated with a 27.2% lower risk of relapse compared with QXR, and a 56.7% reduction in risk of hospitalization. A higher proportion of subjects treated with lurasidone compared with QXR achieved symptomatic remission at Month 6 (60.6% vs. 41.7%; p=0.001) and Month 12 (70.7% vs. 55.3%; p=0.055; OC analyses, with no duration criterion). Using the 6 month duration criterion, subjects receiving LUR were more likely to meet Remission in Schizophrenia Working Group remission criteria compared with QXR (61.9% vs. 46.3%; p<0.05 - LOCF). Conclusion: In this 12-month study, treatment with lurasidone was associated with a greater reduction in risk of relapse and risk of hospitalization compared with QXR. A higher proportion of subjects treated with lurasidone achieved symptomatic remission at 6 and 12 months, and a sustained remission at LOCF-endpoint.

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