ATLANTA — Adjunctive Latuda was associated with significantly improved time to recurrence of mood or depressive episode among individuals with bipolar I disorder and stable response to acute treatment, according to data presented here.
To assess efficacy and safety of adjunctive Latuda (lurasidone hydrochloride, Sunovion Pharmaceuticals, Inc) for maintenance treatment of bipolar disorder in individuals with stable response to acute treatment, Joseph Calabrese, MD, of University Hospital, Cleveland, and colleagues conducted a 28-week randomized, double-blind, placebo-controlled trial preceded by a 12- to 20-week open-label stabilization phase. Study participants met DSM-IV-TR criteria for bipolar I disorder and had at least one manic, mixed manic or depressed episode in the past 2 years. Participants received 20 mg to 80 mg of lurasidone (n = 246) or placebo (n = 250) per day and also received adjunctive lithium or valproate during both phases.
Time to recurrence of any mood event was longer among participants who received lurasidone compared with placebo (HR = 0.71; 95% CI, 0.49-1.04; P = .078), with a 29% reduction in recurrence risk.
Kaplan-Meier estimates of probability of time to recurrence of any mood event at 28 weeks were 20.9% for the lurasidone group and 51.5% for the placebo group (P = .055).
Time to recurrence of a depressive episode was significantly longer among the lurasidone group compared with the placebo group (HR = 0.57; 95% CI, 0.34-0.97; P = .039).
“In this double-blind study of patients with a bipolar I diagnosis who had been stabilized on lurasidone plus lithium or valproate, 28 weeks of continued treatment with adjunctive lurasidone was associated with a trend-significant risk reduction in time to recurrence of any mood event compared to placebo plus lithium or valproate and a significant reduction in time to recurrence of a depressive episode,” Calabrese and colleagues concluded. – by Amanda Oldt
Calabrese J, et al. Lurasidone adjunctive to lithium or valproate for prevention of recurrence in patients with bipolar I disorder: Results of a 28-week study. Presented at: American Psychiatric Association Annual Meeting; May 14-18, 2016; Atlanta.
Disclosure: The study was supported by Sunovion Pharmaceuticals.