LURASIDONE IN THE LONG-TERM TREATMENT OF PATIENTS WITH BIPOLAR DISORDER: A 24-WEEK OPEN-LABEL EXTENSION STUDY.

Abstract

BackgroundThe aim of this study was to evaluate the safety and tolerability of 6 months of open‐label, uncontrolled extension treatment with lurasidone in patients with a diagnosis of bipolar depression who completed 6 weeks of acute treatment.MethodsPatients completing 6 weeks of double‐blind placebo‐controlled treatment with either lurasidone monotherapy (one study) or adjunctive therapy with lithium or valproate (two studies), were treated for 6 months with flexible doses of lurasidone, 20–120 mg/day, in an open‐label, uncontrolled extension study (N = 813; monotherapy, 38.9%; adjunctive therapy, 61.1%). Changes in safety parameters were calculated from double‐blind, acute‐phase baseline to month 6 of the extension phase, using a last observation carried forward (LOCF endpoint) analysis.ResultsFive hundred fifty‐nine of 817 (68.4%) patients completed the extension study. In the monotherapy and adjunctive therapy groups, 6.9 and 9.0%, respectively, discontinued due to an adverse event. For the monotherapy and adjunctive therapy groups, respectively, changes from double‐blind baseline to month 6 were +0.8 and +0.9 kg for weight (mean), 0.0 and +2.0 mg/dL for total cholesterol (median), +5.0 and +5.0 mg/dL for triglycerides (median), −1.0 and 0.0 mg/dL for glucose (median); −22.6 and −21.7 for Montgomery‐Asberg Depression Rating Scale (MADRS; mean); whereas change from open‐label baseline to month 6 were +0.85 and +0.88 kg for weight (mean), and −6.9 and −6.5 for MADRS (mean).ConclusionsSix months of treatment with open‐label lurasidone was safe and well tolerated with minimal effect on weight and metabolic parameters; continued improvement in depressive symptoms was observed.