Phase 3 study of vilazodone for major depressive disorder

Clinical Data, Inc. announced positive top-line results from the second of two Phase 3 trials of its investigational compound, vilazodone, for the treatment of major depressive disorder (MDD). This study was a randomized, double-blind, placebo-controlled trial of 481 patients with MDD conducted at 12 sites in the United States. The study achieved its primary endpoint of demonstrating a reduction in the symptoms of depression, as measured by a statistical separation from placebo, in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after up to 8 weeks of treatment (p=0.007, ITT/LOCF). Vilazodone also met a key secondary endpoint as demonstrated by a statistically significant reduction in depression symptoms, compared to placebo, as measured by mean change from baseline on the Hamilton Depression Rating Scale (HAMD17, p=0.021). These two rating scales are the most common psychometric measures of response to antidepressants used in clinical trials. There was also a statistically significant improvement in symptoms of anxiety associated with depression, as measured by the Hamilton Anxiety Rating Scale (HAMA, p=0.038).

Vilazodone is a potential first-in class drug for the treatment of depression due to its novel dual mechanism of action as both a potent and selective serotonin reuptake inhibitor (SSRI) and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor.

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