Major Depressive Disorder
Vilazodone hydrochloride is used for the treatment of major depressive disorder in adults. The short-term antidepressant efficacy of vilazodone was mainly established in 2 multicenter, randomized, double-blind, placebo-controlled studies of 8 weeks' duration in adult outpatients who met DSM-IV-TR criteria for major depressive disorder. In these studies, patients were titrated over a period of 2 weeks to a vilazodone hydrochloride dosage of 40 mg given once daily with food or to placebo. Vilazodone was found to be more effective than placebo in improving depressive symptoms as measured by the mean change from baseline to week 8 on the Montgomery-Asberg Depression Rating Scale (MADRS) total score in both of these studies. Symptomatic improvement was observed in vilazodone-treated patients as early as the end of 1 week of therapy in one of the two studies. No age- (although there were few patients older than 65 years of age), gender-, or race-related differences in efficacy were noted in these studies.
In a long-term (52-week), multicenter, open-label study, vilazodone hydrochloride given in a dosage of 40 mg once daily was found to be effective and well tolerated in adults with major depressive disorder. Most adverse effects were reportedly mild or moderate in severity and similar to those reported in the short-term studies. In addition, laboratory, vital sign, and ECG findings did not reveal any treatment-related trends.
The manufacturer states that the efficacy of vilazodone for long-term use (i.e., exceeding 8 weeks) has not been systematically established. If the drug is used for extended periods, the need for continued therapy and the appropriate dosage should be reassessed periodically.
For further information on treatment of major depressive disorder and considerations in choosing the most appropriate antidepressant for a particular patient, including considerations related to patient tolerance, patient age, and cardiovascular, sedative, and suicidal risks, .