Efficacy of Lurasidone in Adults Aged 55 Years and Older With Bipolar Depression

Abstract

Objective: The aim of this post hoc analysis was to evaluate the efficacy of lurasidone in patients aged 55 years and older with bipolar depression. Methods: A post hoc analysis was performed on the older adult subgroup (n = 142) of outpatients meeting DSM-IV-TR criteria for bipolar I depression in 2 placebo-controlled, 6-week, randomized, double-blind studies conducted from 2009-2012: a monotherapy study comparing fixed flexibledose ranges of lurasidone 20-60 mg/d or 80-120 mg/d with placebo and an adjunctive therapy study comparing flexible doses of lurasidone 20-120 mg/d with placebo adjunctive to either lithium or valproate. The primary endpoint was mean change at week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Results: In the randomized sample, the proportion of older adults was 88/505 (17.4%) in the monotherapy study and 54/348 (15.5%) in the adjunctive therapy study. In the older adult subgroup in the monotherapy study, mean change at week 6 in the MADRS was significantly greater for lurasidone versus placebo (−14.8 vs −7.1; P = .003; effect size, 0.83; pooled doses), and in the adjunctive therapy study, mean change for lurasidone was not significantly different from placebo (−13.9 vs −11.1; P = .398; effect size, 0.26). Discontinuation rates due to adverse events for lurasidone versus placebo were similar for the monotherapy (6.8% vs 6.9%) and adjunctive therapy (3.8% vs 7.1%) studies. Lurasidone had minimal effects on metabolic laboratory values. Conclusions:The results of these post hoc analyses, which assessed the efficacy of lurasidone in older adults with bipolar disorder, found that monotherapy was significantly effective while adjunctive therapy was not associated with significant improvement. Both monotherapy and adjunctive therapy with lurasidone were safe and well-tolerated in this older adult population. Trial Registration: ClinicalTrials.gov identifiers: NCT00868699, NCT00868452.

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

“…Post hoc analyses of RCTs suggest efficacy of quetiapine (level 2)661 and lurasidone (level 2)662 monotherapy and hence these are recommended as first‐line options. However, in older adults, given the concerns about side effects of atypical antipsychotics, clinicians may wish to try lithium or lamotrigine first based on their efficacy in adult populations, although the evidence of efficacy is limited in older adults (lithium, level 4; lamotrigine, level 4) 663, 664.…”

A Review of the Pharmacological and Clinical Profile of Newer Atypical Antipsychotics as Treatments for Bipolar Disorder: Considerations for Use in Older Patients

“…Lurasidone was found to be safe and well-tolerated, as evidenced by reasonably low discontinuation rates in both the monotherapy and adjunctive therapy studies (< 7.1%) [40]. Additionally, there were minimal effects on metabolic laboratory values [40].…”

“…A post hoc analysis of an older adult cohort was conducted on data from two previous double-blind, placebo-controlled studies of lurasidone in the acute treatment of adult bipolar depression [40]. This post hoc analysis specifically evaluated the efficacy and safety of lurasidone in a late-life bipolar depression sample (n = 142, age > 55 years).…”

“…This post hoc analysis specifically evaluated the efficacy and safety of lurasidone in a late-life bipolar depression sample (n = 142, age > 55 years). Lurasidone was administered at 20-120 mg/day, either as monotherapy or adjunctive therapy to either lithium or valproate [40]. In the monotherapy group, a mean change at week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) was significantly greater for lurasidone versus placebo (− 14.8 vs. − 7.1; p = 0.003; effect size 0.83; pooled doses), while in the adjunctive therapy group, mean change in MADRS scores in the lurasidone group was not significantly different from the placebo group (− 13.9 vs. − 11.1; p = 0.398; effect size 0.26) [40].…”

“…Lurasidone was administered at 20-120 mg/day, either as monotherapy or adjunctive therapy to either lithium or valproate [40]. In the monotherapy group, a mean change at week 6 on the Montgomery-Asberg Depression Rating Scale (MADRS) was significantly greater for lurasidone versus placebo (− 14.8 vs. − 7.1; p = 0.003; effect size 0.83; pooled doses), while in the adjunctive therapy group, mean change in MADRS scores in the lurasidone group was not significantly different from the placebo group (− 13.9 vs. − 11.1; p = 0.398; effect size 0.26) [40]. Lurasidone was found to be safe and well-tolerated, as evidenced by reasonably low discontinuation rates in both the monotherapy and adjunctive therapy studies (< 7.1%) [40].…”