Updated on 21 May 2015
Sunovion, an indirect, wholly-owned subsidiary of Japan's Sumitomo Dainippon Pharma Co. Ltd., announced results from the first placebo-controlled study in adults with major depressive disorder (MDD) who presented with a limited number of associated manic symptoms (mixed features).
The study demonstrated that Latuda (lurasidone HCl) significantly reduced depressive symptoms in adults with MDD with mixed features when compared to placebo. The study results were presented at the 168th Annual Meeting of the American Psychiatric Association (APA).
LATUDA is an atypical antipsychotic agent indicated in the United States for the treatment of adult patients with major depressive episodes associated with bipolar I disorder (bipolar depression) both as monotherapy and as adjunctive therapy with lithium or valproate, and for the treatment of adult patients with schizophrenia.
In this randomized, double-blind, placebo-controlled, 6-week clinical trial, adults patients with MDD with a limited number of manic symptoms (mixed features) were randomized to receive 6 weeks of treatment with flexibly-dosed LATUDA 20 - 60 mg/day (N=109) or placebo (N=102). The primary efficacy endpoint in the study was change from baseline at Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The key secondary endpoint was change from baseline at Week 6 in the Clinical Global Impression, Severity (CGI-S) score, which assessed global severity of illness.
Results from the study showed that treatment with LATUDA was associated with a statistically significant reduction in MADRS total scores at the end of the study (Week 6) compared with placebo, with separation from placebo starting at the first post-baseline assessment (Week 1). In addition, patients treated with LATUDA experienced a statistically significant reduction in change from baseline at Week 6 in CGI-S scores compared with placebo, with separation from placebo starting at Week 2, as well as significant differences from placebo on all other secondary efficacy endpoints, including manic symptoms (based on Young Mania Rating Scale assessment).
LATUDA was generally well-tolerated with low rates of change in weight and metabolic parameters and had an overall discontinuation rate that was lower than placebo. The most common adverse events (AEs) reported with an incidence ≥ 5% and greater than placebo in patients receiving LATUDA vs. placebo were nausea and somnolence (including the combined terms hypersomnia, hypersomnolence, sedation and somnolence).