Clinical Guidance: Treatment of Bipolar Depression With Lurasidone
The antipsychotic lurasidone was recently approved for bipolar I depressive episodes. In a 6-week study of moderately depressed outpatients, lurasidone monotherapy demonstrated response rates of 53% for low-dose (20–60 mg/day) and 51% for high-dose (80–120 mg/day) treatment, compared to 30% in the placebo group. Loebel et al. (p. 160) report that the rates of treatment-emergent mania were 3.7% for low-dose treatment and 1.9% for placebo and high-dose treatment. Nausea and somnolence were common side effects. In another 6-week study of depressed outpatients (p. 169), lurasidone as an adjunct to lithium or valproate demonstrated a response rate of 57%, compared to 42% for placebo. The mean daily dose of lurasidone was 66.3 mg. In both treatment and placebo groups, lithium and valproate levels were maintained at 0.6–1.2 mEq/L and 50–125 μg/ml, respectively. Treatment-emergent mania occurred in 1.1% of the lurasidone group and 1.2% of the placebo group. Rates of treatment-emergent suicidality were 9% for lurasidone and 6% for placebo. In the monotherapy study, suicidality was 14% in all three groups. Belmaker comments in an editorial (p. 131) on antipsychotics’ efficacy for bipolar disorder and how this contributes to the unitary psychosis theory.