Lurasidone: A Review of Its Use in Adult Patients with Bipolar I Depression

Lurasidone (Latuda^®), a benzisothiazole derivative antipsychotic, is approved in the USA and Canada for the treatment of adults with major depressive episodes (MDE) associated with bipolar I disorder; this article reviews studies of lurasidone in this indication. In two 6-week, placebo-controlled trials in adults with bipolar I depression, lurasidone 20–120 mg/day reduced depressive symptoms, either as monotherapy or as an adjunct to lithium or valproate. Lurasidone reduced the mean Montgomery–Åsberg Depression Rating Scale (MADRS) total score from baseline (primary endpoint) by >50 %; the reductions in scores were significantly greater than with placebo. The treatment effects were small to medium and the numbers needed to treat to obtain an additional MDE response (≥50 % reduction from baseline in the MADRS total score) were ≤7 across the lurasidone groups. In a third, similarly designed trial of lurasidone 20–120 mg/day adjunctive to lithium or valproate, there was no significant between-group difference in the change in the mean MADRS total score at week 6 (primary endpoint), although significant differences favouring lurasidone were observed from week 2 to week 5. Across trials, the most frequently occurring adverse events included akathisia, extrapyramidal symptoms and somnolence. Lurasidone had a favourable profile with respect to weight gain and metabolic disturbances, known to occur with some other antipsychotics. Thus, lurasidone offers a valuable addition to the therapies available for adult patients with bipolar depression, either as monotherapy or as an adjunct to lithium or valproate.