Optimizing Treatment with Lurasidone in Patients with Schizophrenia: Results of a Randomized, Double-blind, Placebo-controlled Trial

Abstract

Introduction Controlled data on optimization of dosing regimen for antipsychotics in schizophrenia is an unmet medical need. Objective/Aims To evaluate the efficacy of low dose lurasidone in schizophrenia; and to determine optimal dosing for patients not achieving improvement in Positive and Negative Syndrome Scale (PANSS) total score by week 2 of standard dosing. Methods Patients with schizophrenia were randomized to double-blind treatment with fixed daily doses of lurasidone 18.5 mg (for 6 wks; N=101), 74 mg (for 2 wks; N=198), or placebo (for 6 wks; N=112). After 2 weeks of treatment, patients in the 74 mg group with Results Lurasidone 18.5 mg did not demonstrate significant improvement vs. placebo at Week 6 (−17.6 vs −14.5; P=0.25). In the group with Conclusions This trial supports the 37 mg/d dose of lurasidone as minimally effective dose in patients with acute schizophrenia consistent with evidence from previous studies. Increasing the dose of lurasidone to 148 mg/d after 2 weeks of nonresponse at 74 mg/d resulted in a significant efficacy advantage with important potential implications for clinical practice. NCT01821378. Sponsored by Sunovion Pharmaceuticals Inc.