Remission in Lurasidone-treated Patients with Bipolar I Depression: Post-hoc Analysis of a 6-week, Placebo-controlled Trial Followed by a 6-month Extension

Abstract

Background The objective of this post-hoc analysis was to evaluate recovery-related outcomes in patients with bipolar depression treated with lurasidone. Methods Subjects meeting DSM-IV-TR criteria for bipolar I depression, with or without rapid cycling, were randomized to 6 weeks of once-daily, double-blind treatment with either lurasidone 20-60 mg (LUR20-60), lurasidone 80-120 mg (LUR80-120) or placebo (PBO), followed by a 6-month, open-label, continuation study of lurasidone. Results At end of the 6-week acute phase, a significantly higher proportion of subjects met both symptomatic (MADRS total score ≤ 12) and functional (mean SDS total score ≤ 3 and all SDS domain scores ≤ 3 for mildly impairment) remission criteria in the lurasidone group (33%,N=273 pooling the LUR20-60 and LUR80-120 groups) compared to the placebo group (15%, N=143,p Discussion Our findings support the potential for attainment of remission in patients with bipolar I depression treated with lurasidone, which might lead to clinical and functional recovery.