Sunovion announced new results from the first placebo-controlled study evaluating Latuda (lurasidone HCl) in adults with major depressive disorder (MDD) who presented with mixed (subsyndromal hypomanic) features. Results from the study were presented at the 168th Annual Meeting of the American Psychiatric Association (APA).
The randomized, double-blind, placebo-controlled trial randomized adults with MDD with a limited number of manic symptoms to six weeks of flex-dose Latuda 20mg–60mg/day (n=109) or placebo (n=102). The primary efficacy endpoint was change from baseline at Week 6 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score.
Study authors found that treatment with Latuda resulted in a statistically significant reduction in MADRS total score by Week 6 vs. placebo (-20.5 vs. -13.0; P<0.0001) with separation from placebo seen from Week 1. Patients treated with Latuda also showed a statistically significant reduction in change from baseline at Week 6 in Clinical Global Impression, Severity (CGI-S) scores vs. placebo (-1.83 vs. -1.18; P<0.0001) with separation from placebo seen from Week 2. Significant changes from placebo on all other secondary efficacy endpoints, including manic symptoms were seen.
Latuda is an atypical antipsychotic indicated for depressive episodes associated with bipolar I disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate, as well as for the treatment of schizophrenia.
For more information call (800) 739-0565 or visit Latuda.com.