Health-Related Quality of Life in Patients with Bipolar Depression Treated With Lurasidone

OBJECTIVES: Anchor-based responder analysis using validated clinical measures help in understanding if statistically significant changes in patient reported health-related quality of life (HRQoL) are clinically meaningful. The objective of this study was to estimate the proportion of patients in lurasidone bipolar depression trials who achieved clinically meaningful improvement in HRQoL.

METHODS: Post-hoc analysis of data from two 6-week, randomized, double-blind, placebo-controlled clinical trials of lurasidone as a monotherapy (PREVAIL-1: 20-60 mg or 80-120 mg) or adjunctive therapy with lithium or valproate (PREVAIL-2: 20-120 mg). Clinically meaningful HRQoL improvement at 6-weeks was determined using an anchor-based method. The Clinical Global Impression-Severity-Bipolar Version (CGI-BP-S) scale (range: 1-7) was the clinical anchor for the 16-item Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q SF) HRQoL measure that assesses functional impact on social and physical activities (range: 0-100).

RESULTS: Pooling across treatment groups, data from 364 and 275 patients were available from PREVAIL-1 and 2, respectively. For patients demonstrating clinically meaningful improvement (1-point score change) on the CGI-BP-S over 6-weeks, mean Q-LES-Q SF change was 15.6 points for PREVAIL-1 and 14.9 points for PREVAIL-2. A significantly greater proportion of lurasidone treated patients also reported meaningful HRQoL improvements compared to placebo in PREVAIL-1 (69% vs 43%) and PREVAIL-2 (69% vs 57%).

CONCLUSIONS: This post-hoc analysis demonstrated that lurasidone monotherapy and adjunctive therapy is associated with clinically meaningful HRQoL improvement in patients with bipolar depression and significantly more lurasidone patients were HRQoL responders than placebo in both trials.