A prospective randomized comparative study of safety and efficacy of vilazodone and fluoxetine in depression

Abstract

Depression is one of the leading causes of disease burden globally. Over the past 6 decades we have seen a multitude of antidepressants from different classes. Vilazodone is a novel antidepressant with the combination of serotonin reuptake inhibition and 5HT1A partial agonism. We wished to study its efficacy and safety in comparison to fluoxetine, in the Indian population. This is a 6-week prospective randomized open label comparative study of efficacy and safety of vilazodone and fluoxetine in patients with major depressive disorder. We recruited 72 subjects and 66 completed the study. We rated the overall severity and improvement in psychopathology by using CGI-S and CGI-I, respectively on three occasions, i.e. day 1, week 3 and week 6. We also recorded and compared the side effects of study medication with the checklist from the vilazodone prescribing information, during week 3 and 6. We compared the efficacy data using independent t test and repeated measures analysis of variance (ANOVA), and side effects using Pearson Chi-Square test. The socio-demographic data was evenly distributed except for literacy, which was significantly better in the vilazodone group. There was no significant difference in the efficacy of fluoxetine and vilazodone both at week 3 and week 6. However patients on vilazodone reported significantly higher gastrointestinal side effects. The efficacy of vilazodone is comparable to fluoxetine in the Indian population in the short-term treatment of depression, though associated with frequent gastrointestinal side effects. We need further blinded studies on long term efficacy and safety, with a larger sample size to generalize the results.