A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder

Carl Gommoll, Suresh Durgam, Maju Mathews, Giovanna Forero, Rene Nunez, Xiongwen Tang, Michael E Thase, Carl Gommoll, Suresh Durgam, Maju Mathews, Giovanna Forero, Rene Nunez, Xiongwen Tang, Michael E Thase

Abstract

Background: Vilazodone, a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist, is approved for treating major depressive disorder in adults. This study (NCT01629966 ClinicalTrials.gov) evaluated the efficacy and safety of vilazodone in adults with generalized anxiety disorder (GAD).

Methods: A multicenter, double-blind, parallel-group, placebo-controlled, fixed-dose study in patients with GAD randomized (1:1:1) to placebo (n = 223), or vilazodone 20 mg/day (n = 230) or 40 mg/day (n = 227). Primary and secondary efficacy parameters were total score change from baseline to week 8 on the Hamilton Rating Scale for Anxiety (HAMA) and Sheehan Disability Scale (SDS), respectively, analyzed using a predefined mixed-effect model for repeated measures (MMRM). Safety outcomes were presented by descriptive statistics.

Results: The least squares mean difference (95% confidence interval) in HAMA total score change from baseline (MMRM) was statistically significant for vilazodone 40 mg/day versus placebo (-1.80 [-3.26, -0.34]; P = .0312 [adjusted for multiple comparisons]), but not for vilazodone 20 mg/day versus placebo. Mean change from baseline in SDS total score was not significantly different for either dose of vilazodone versus placebo when adjusted for multiplicity; significant improvement versus placebo was noted for vilazodone 40 mg/day without adjustment for multiplicity (P = .0349). The incidence of adverse events was similar for vilazodone 20 and 40 mg/day (∼71%) and slightly lower for placebo (62%). Nausea, diarrhea, dizziness, vomiting, and fatigue were reported in ≥5% of patients in either vilazodone group and at least twice the rate of placebo.

Conclusions: Vilazodone was effective in treating anxiety symptoms of GAD. No new safety concerns were identified.

Keywords: antidepressant; anxiety/anxiety disorders; clinical trials; generalized anxiety disorder; pharmacotherapy.

© 2015 The Authors. Depression and Anxiety published by Wiley Periodicals, Inc.

Figures

Figure 1
Figure 1
HAMA total score mean change from baseline (MMRM, ITT population). The least squares mean change from baseline in HAMA total score was significantly greater for vilazodone 40 mg/day versus placebo beginning at week 2; the significant difference persisted throughout double-blind treatment. P-values shown are for vilazodone 40 mg/day versus placebo and were not adjusted for multiplicity. Vilazodone 20 mg/day was not statistically different versus placebo at any visit.

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