Lurasidone switching in patients with schizophrenia who showed suboptimal effect and/or intolerability to current antipsychotics: A multi-center, open-label, single-arm, flexible dose study

Abstract

Objective: In this study, we intended to evaluate the effectiveness and safety of switching to lurasidone in patients with schizophrenia and to get clinical experiences of real-world practice in those who showed suboptimal therapeutic effect and/or intolerability to lurasidone in Taiwan. Methods: We enrolled adult patients (aged 20–75 years) with schizophrenia who had been receiving antipsychotic medications but still continued to show mild-to-moderate symptoms or intolerability, for switching switch to an open-label lurasidone 40–160 mg daily for six weeks. The primary end point of the study was to assess the time to treatment failure, defined as any occurrence of insufficient clinical response, worsen underlying symptoms, or discontinuation due to adverse events. Secondary efficacy measures of the study included decreased scores in the positive and negative syndrome scale (PANSS) total and the clinical global impression-severity scale.(CGI-S), as well as increased clinical global impression-improvement scale (CGI-I). Safety measures included occurrences of treatment-emergent adverse events (TEAEs), abnormal vital signs, Electrocardiogram (ECG), and laboratory parameters. Results: We enrolled 54 patients with 51 completing the study. One patient terminated early due to adverse events and two patients had insufficient therapeutic efficacy. Mean ± standard deviation (SD) time to treatment failure was 27.7 ± 13.1 days. Mean ± SD changes from baseline to six weeks on PANSS, CGI-S, and were −16.8 ± 14.4, −0.6 ± 0.59, and −1.1 ± 1.0, respectively . The most common TEAE was hyperprolactinemia. Furthermore, body weight was significantly decreased from baseline to the end of the study by 0.83 ± 1.96 kg (p < 0.01). Mean ± SD blood prolactin level also was significantly decreased from baseline to week 6 (48.7 ± 52.8 ng/dL vs. 23.9 ± 57.8 ng/dL, p < 0.001). Conclusion: After switching from another antipsychotic, patients with schizophrenia treated with lurasidone showed a low rate of treatment failure among patients in Taiwan. The safety profile is similar to that in previous published lurasidone studies.