• Carole Dembek, Qi Fan, Xiaoli Niu, Yongcai Mao, Vamshi Ruthwik Anupindi, Kimberly Laubmeier, and Michael Tocco.
• Sunovion Pharmaceuticals Inc, Marlborough, MA, USA.
• Curr Med Res Opin. 2022 Sep 1; 38 (9): 161316191613-1619.

ObjectiveThe objective of this post-hoc analysis was to assess the impact of lurasidone monotherapy on health-related quality of life (HRQoL) in adults with bipolar depression.MethodsData were analyzed from a 6-week randomized, double-blind (DB), placebo-controlled trial of lurasidone monotherapy (NCT00868699) and a 6-month open label extension (OLE; NCT00868959). Patients who received lurasidone monotherapy or placebo during the DB trial were eligible to continue or switch to lurasidone monotherapy during the OLE. The 16-item Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) was collected at DB baseline, DB week 6/OLE baseline, OLE month 3, and OLE month 6. Effect size (ES) and mean changes from baseline were reported for Q-LES-Q-SF total and item scores during the DB trial and OLE, respectively.ResultsOf 485 patients in the DB trial (lurasidone monotherapy: n = 323; placebo: n = 162), 316 patients continued or switched to lurasidone monotherapy during the OLE. Significant improvements in Q-LES-Q-SF scores in lurasidone vs. placebo were reported for 13 of 16 items (all p < .05) at DB week 6. The greatest improvements were overall life satisfaction (ES = 0.57), social relationships (0.55), medication satisfaction (0.48), family relationships (0.46), and ability to function in daily life (0.45, all p < .001). Improvements in Q-LES-Q-SF total and item scores were sustained at OLE month 6.ConclusionsTreatment with lurasidone provided a significant improvement across HRQoL items including overall life satisfaction, social and family relationships, medication satisfaction, and ability to function in daily life. Improvements were sustained during the 6-month OLE.

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