Efficacy and Tolerability of Lurasidone in Older Adults with Bipolar Depression: Analysis of Two 6-week Double-blind, Placebo-controlled Studies

Abstract

The acute treatment of bipolar depression in the elderly has not been well-studied. To evaluate the acute efficacy and tolerability of lurasidone in older adults (age ≥55 years) with bipolar I depression (BPD). The older adult sample was analyzed from two, randomized, double-blind, 6-week studies of BPD patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20: a monotherapy trial (lurasidone 18.5-56 mg/d vs 74-111 mg/d vs placebo); and an adjunctive trial (with lithium or valproate; lurasidone 18.5-111 mg/d vs placebo). The older adult sample consisted of 83 patients (17.1%) on monotherapy, and 53 patients (15.6%) on adjunctive therapy. At Week 6, mean change in MADRS was significantly greater for lurasidone 18.5-56 mg (-15.4; P <0.01; effect size=0.86) and 74-111 mg (-14.1; P <0.02; effect size=0.74) vs placebo (-7.1). Adjunctive therapy with lurasidone (vs placebo) was associated with numerically greater improvement at Week 6 in MADRS (-13.9 vs. -11.1; ns; effect size=0.26). Among older adults in the monotherapy study, discontinuation due to adverse events occurred in 7.7% of patients on lurasidone 18.5-56 mg, 6.7% on lurasidone 74-111 mg, and 3.7% on placebo; and in the adjunctive therapy study, discontinuation due to adverse events occurred in 3.8% of patients on lurasidone, and 7.4% on placebo. Results of these analyses suggest that lurasidone, in doses of 18.5-111 mg, was an efficacious and well-tolerated acute treatment for bipolar depression in older adults. Significance vs placebo was achieved with lurasidone monotherapy, however, adjunctive therapy with lurasidone did not reach statistical significance. NCT00868699, NCT00868452. Sponsored by Sunovion Pharmaceuticals Inc.