Vilazodone, a novel dual-acting serotonergic antidepressant for managing major depression.

Major depressive disorder (MDD) affects <or= 15% of the general population and imparts a significant economic and psychosocial burden. Despite the availability of a wide range of drugs for treating MDD, the majority of patients fail to achieve complete and sustained remission of symptoms. Vilazodone is a novel dual-acting serotonergic antidepressant currently in clinical development for the treatment of MDD. Vilazodone combines the effects of a selective serotonin reuptake inhibitor with 5-HT(1A) receptor partial agonist activity. In a recent Phase III clinical trial, vilazodone showed significant antidepressant efficacy compared to placebo with a statistically significant onset of effect at 1 week. Overall dropout rates were low. Diarrhea, nausea and headache were the most common adverse events reported. In addition, there was no significant difference between placebo and vilazodone in terms of sexual dysfunction as measured by the Arizona Sexual Experiences Scale. A unique feature of the vilazodone clinical program is the concurrent development of biomarkers that may predict treatment response and common side effects. Vilazodone offers a dual mechanism of action, good general tolerability with the potential for less impairment of sexual function than selective serotonin reuptake inhibitors and the possibility of personalized treatment for MDD.