TORONTO —According to phase 3 study results presented here, Latuda, an atypical antipsychotic agent, significantly reduced depressive symptoms among adults with major depressive disorder with limited manic symptoms.
In the United States, Latuda (lurasidone hydrochloride, Sunovion Pharmaceuticals, Inc) is indicated for adults with major depressive episodes associated with bipolar I disorder as a monotherapy and as an adjunctive therapy with lithium or valproate, and for adults with schizophrenia.
Trisha Suppes, MD, PhD, of Stanford University School of Medicine, and colleagues randomly assigned adults with major depressive disorder with a limited number of manic symptoms to receive 20 mg to 60 mg flexibly dosed lurasidone hydrochloride per day (n = 109) or placebo (n = 102) for 6 weeks.
Lurasidone hydrochloride was associated with reductions in Montgomery-Asberg Depression Rating Scale (MADRS) scores (P < .0001) and Clinical Global Impression, Severity (CGI-S) scores (P < .0001) compared with placebo.
Patients who received lurasidone hydrochloride had low rates of change in weight and metabolic parameters. Nausea and somnolence were the most commonly reported adverse events among those who received lurasidone hydrochloride.
Discontinuation was less common among patients who received lurasidone hydrochloride vs. those who received placebo (6.4% vs. 14.7%).
“These results demonstrate that Latuda significantly reduced depressive symptoms in adult patients with an often severe form of depression, [major depressive disorder] with mixed features,” Anthony Loebel, MD, executive vice president and chief medical officer of Sunovion Pharmaceuticals, Inc, said in a press release. “We believe this is an important finding as patients with this condition may not respond adequately to standard antidepressant treatment.” – by Amanda Oldt
Suppes T. P8-064. Presented at: American Psychiatric Association Annual Meeting; May 16-20, 2015; Toronto.
Disclosure: Suppes reports financial ties with AstraZeneca and Pfizer.