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Latuda effective for depression, mania in major depressive disorder with mixed features

Latuda, an atypical antipsychotic currently intended for schizophrenia and bipolar I disorder, improved depressive and manic symptoms and overall illness severity among individuals with major depressive disorder with mixed features.

“No controlled trials to date have investigated the efficacy of any psychotropic agent in the treatment of major depressive disorder with mixed features. While standard antidepressants are widely used in the treatment of major depressive disorder, the efficacy and safety of these agents in patients with mixed features has not been established and is not well understood,” Trisha Suppes, MD, PhD, of Stanford School of Medicine, California, and colleagues wrote. “Atypical antipsychotics have been shown to have mood-stabilizing properties, and selected agents have demonstrated antidepressant efficacy in bipolar depression. [Latuda (lurasidone, Sunovion Pharmaceuticals)] has demonstrated efficacy in the treatment of bipolar depression, both as a monotherapy and as an adjunctive therapy with lithium or valproate.”

Trisha Suppes

To evaluate efficacy of lurasidone for major depressive disorder with mixed features, researchers randomly assigned individuals with MDD and two or three manic symptoms to 6 weeks of double-blind treatment with lurasidone at 20 mg to 60 mg/day (n = 109) or placebo (n = 100). Changes in Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impressions severity subscale (CGI-S) scores were assessed from baseline to week 6.

Least squares mean change in MADRS scores from baseline to week 6 were –20.5 among individuals who received lurasidone and –13 among those who received placebo (P < .001).

CGI-S scores had least squares mean change of –1.8 among individuals who received lurasidone and –1.2 among those who received placebo (P < .001) from baseline to week 6.

These data suggest lurasidone significantly improved depressive symptoms and overall illness severity, according to researchers.

Manic symptoms also significantly improved after receiving lurasidone, with least squares mean change in Young Mania Rating Scale scores of –7 among individuals who received lurasidone and –4.9 among those who received placebo (P < .001).

Discontinuation and adverse event rates were low, according to researchers.

The most common adverse events were nausea and somnolence.

“Lurasidone was found to be an efficacious treatment in this patient population, with improvements observed in depressive and subthreshold hypomanic symptoms, anxiety symptoms and functional impairment,” Suppes and colleagues wrote. “Treatment with lurasidone was well-tolerated, with a favorable benefit-risk profile in this difficult-to-treat clinical population. Further investigation is needed to determine whether these findings are applicable to other agents in the atypical antipsychotic class.” – by Amanda Oldt

Disclosure: Suppes reports receiving funding, medications for clinical grants, consulting fees, or travel expenses from AstraZeneca, Elan Pharma International, Lundbeck, Merck, NIMH, VA Cooperative Studies Program, and Sunovion and royalties from UpToDate and Jones and Bartlett (formerly Compact Clinicals). Please see the full study for a list of all authors’ relevant financial disclosures.