Efficacy Of Vilazodone Research Articles

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

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

27.4 Vilazodone: Adult and Pediatric Patients

The goal of this presentation is to understand the pharmacology and efficacy of vilazodone in adult and pediatric patients.

Efficacy and tolerability of vilazodone for the acute treatment of generalized anxiety disorder: A meta-analysis.

A systematic review and meta-analysis of all relevant randomized controlled trials was conducted to evaluate the safety and efficacy of vilazodone in the acute treatment of generalized anxiety disorder (GAD). The literature was searched through all relevant databases in order to identify clinical trials on the use of vilazodone in the treatment of GAD. Once the trials were identified, data was extracted and analyzed using Revman5.3 and open meta-analyst. Assessment of continuous outcomes relied upon standardized mean difference, while binary outcomes were evaluated via relative risk, absolute risk reduction and NNT/NNH. A total of 3 well-designed randomized controlled trials with a duration of 10 weeks were conducted, with a total of 844 (intent to treat population) randomized to vilazodone (20-40mg, mean dose=31.42mg) and 618 to placebo. The study drug was significantly superior (p<0.001) to placebo in continuous primary outcome measures (HAMA reduction at week 8, CGI-S reduction at week 8 and CGI-I score at week 8). Binary outcome measures however are not as promising, probably reflecting a small effect size [NNT=10 (6.67, 21.28) for induction of response according to the HAMA scale and NNT=12 (7.58, 34.48) for the CGI-I scale], although statistical significance (p<0.01) was attained for both. The study drug was significantly (p<0.001) more likely than placebo to induce adverse effects and to be discontinued due to adverse effects NNH=14 (10.31, 22.22), most common of which were nausea and diarrhea. Vilazodone was superior to placebo in the short term treatment of GAD. However, due to the small effect size and high incidence of adverse events, the utility of vilazodone in the treatment of GAD remains unclear. Likelihood to be helped (HAMA response) or harmed (discontinuation due to adverse events) was inconclusive [1.4 (0.48, 3.33)], demonstrating a need for further trials and direct comparisons of vilazodone to the standard treatments for the disorder. Thus vilazodone cannot be recommended yet as a first line agent. Vilazodone is an effective treatment for generalized anxiety disorder, though further trials are required for a more adequate comparison with established treatments, as well as long term maintenance studies to determine the validity of claims regarding the absence of sexual side effects.

The efficacy profile of vilazodone, a novel antidepressant for the treatment of major depressive disorder

Objective:Vilazodone is a novel serotonin reuptake inhibitor and serotonin 1A receptor partial agonist approved for the treatment of major depressive disorder (MDD). This evaluation presents side-by-side efficacy data from two randomized, double-blind, placebo-controlled, short-term 8-week trials (referred to as randomized controlled trial [RCT]-1 [N = 410] and RCT-2 [N = 481]); efficacy data for demographic and clinical subgroups (derived from pooled RCT data); and effectiveness data from a 52-week, open-label, long-term study (N = 616). The objective is to summarize the efficacy profile of vilazodone at its approved dose of 40 mg/day.Methods:The main assessment in individual pivotal trials and pooled subgroup analyses was the change from baseline to end of treatment (EOT, 8 weeks) in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score. Mixed-effects repeated-measures analyses were conducted in the placebo-controlled trials. Effectiveness analyses in the long-term study included mean MADRS score change over time.Results:Vilazodone-treated patients in both short-term studies showed greater improvement from baseline to EOT in mean MADRS scores than placebo-treated patients (least-squares mean [LSM] treatment difference: −3.2 [p = 0.001], RCT-1; −2.5 [p = 0.009], RCT-2). Clinical Global Impressions–Improvement mean scores at EOT reflected greater improvement with vilazodone compared with placebo in both studies (LSM treatment difference: −0.4 [p = 0.001], RCT-1; −0.3 [p = 0.004], RCT-2). MADRS response rates were significantly greater among patients receiving vilazodone versus those receiving placebo (RCT-1: 40.4% versus 28.1%, respectively [p = 0.007]; RCT-2: 43.7% versus 30.3%, respectively [p = 0.002]). The greater efficacy of vilazodone versus placebo was consistent for the majority of demographic and MDD characteristic subgroups. In the long-term study, the mean MADRS score improved from 29.9 (baseline) to 11.4 (week 8), 8.2 (week 24), and 7.1 (week 52).Conclusion:Vilazodone 40 mg/day resulted in clinically meaningful, statistically significant improvement in MDD symptoms in two placebo-controlled, 8-week studies. Findings are supported by subgroup analysis and open-label, long-term effectiveness data.Trial registration:Trial registration: ClinicalTrials.gov identifier: NCT00285376.Trial registration: ClinicalTrials.gov identifier: NCT00683592.Trial registration: ClinicalTrials.gov identifier: NCT00644358.