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

Abstract

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.

An Open Trial of Lurasidone as an Acute and Maintenance Adjunctive Treatment for Outpatients With Treatment-Resistant Bipolar Disorder

“…4 The effective low doses in our study are consistent with the successful dose ranges reported in the FDA clinical trials of acute antidepressant effects of lurasidone. 8 Our results also confirm that lurasidone has a favorable benefit-risk ratio in both acute and maintenance treatment of BD MDE. The most significant common adverse effects during both phases were overactivation in nature.…”

Royal Australian and New Zealand College of Psychiatrists clinical practice guidelines for mood disorders

“…Whilst lamotrigine has been found to be effective for some patients with BD II, for other patients it may not provide any benefit. Atypical antipsychotic medications such as quetiapine, olanzapine and lurasidone, have shown significant benefits in bipolar depression (Level II) (Azorin et al, 2013; Bawa and Scarff, 2015; Janicak and Rado, 2011; Loebel et al, 2014a; Sanford and Dhillon, 2015; Sanford and Keating, 2012; Tohen et al, 2013; Vieta and Valenti, 2013). Asenapine may also be helpful (Azorin et al, 2013).…”

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 2: Review, Grading of the Evidence, and a Precise Algorithm

“…Response to a single ketamine infusion appears within minutes but does not last more than 3 to 4 days (Young et al, 2000; Diazgranados et al, 2010; Zarate et al, 2012; Loebel et al, 2014b; Xu et al, 2015a). However, there is one unpublished failed study with lurasidone as add-on to lithum or valproate (Suppes et al, 2013; Sanford and Dhillon, 2015). A small placebo-controlled adjunctive study of aripiprazole to lithium and citalopram was negative.…”