Differences in the incidence of lurasidone adverse events between depressive disorders and schizophrenia in double-blind, randomized, placebo-controlled trials: a meta-analysis.

Rationale: We conducted a meta-analysis of double-blind, randomized placebo-controlled trials of lurasidone (LUR) to examine the difference in the risk ratios (RRs) for adverse events (AEs) between depressive disorders (bipolar depression and major depressive disorders) and schizophrenia.

Objectives: Three trials for depressive disorders (n = 1,239) were used for flexible-dose LUR 20-60 (LUR20-60) and/or 80-120 (LUR80-120) mg/day. Nine schizophrenia trials (n = 2,684) were used for fixed-dose LUR. The RRs of LUR20-60 and LUR80-120 for depressive disorders were compared with those of LUR 40 (LUR40) and LUR 80 (LUR80) mg/day for schizophrenia, respectively, to match LUR dose.

Results: LUR20-60 caused a higher incidence of akathisia (RR = 2.28; p = 0.003) and weight gain (RR = 4.11; p = 0.05) than placebo in patients with depressive disorders, and LUR40 caused a higher incidence of akathisia (RR = 2.39; p = 0.0001), extrapyramidal symptoms (RR = 1.88; p = 0.02), anticholinergic drug use (RR = 1.58; p = 0.005), somnolence (RR = 2.19; p = 0.002), and dizziness (RR = 2.06; p = 0.05) than placebo in patients with schizophrenia. However, no significant differences in the RRs for all outcomes were found between depressive disorders and schizophrenia. LUR80-120 caused a higher incidence of akathisia (RR = 3.90; p < 0.0001), extrapyramidal symptoms (RR = 2.26; p = 0.04), anticholinergic use (RR = 4.70; p < 0.0001), and nausea (RR = 2.15; p = 0.001) than placebo in patients with depressive disorders. LUR80 caused a higher incidence of akathisia (RR = 2.99; p < 0.0001), extrapyramidal symptoms (RR = 2.55; p = 0.01), anticholinergic use (RR = 1.86; p = 0.01), somnolence (RR = 2.46; p = 0.001), and nausea (RR = 1.64; p = 0.04) than placebo in patients with schizophrenia. Depressive disorders had a higher RR for anticholinergic use than schizophrenia (p = 0.04).

Conclusions: The incidence of AEs did not differ between schizophrenia and depressive disorders.