title: A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder.
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.
authors.affiliation: Forest Research Institute (an affiliate of Actavis Inc.), Jersey City, New Jersey.
authors.forename: Carl
authors.initials: C
authors.lastname: Gommoll
authors.affiliation: Forest Research Institute (an affiliate of Actavis Inc.), Jersey City, New Jersey.
authors.forename: Suresh
authors.initials: S
authors.lastname: Durgam
authors.affiliation: Forest Research Institute (an affiliate of Actavis Inc.), Jersey City, New Jersey; at time of studies.
authors.forename: Maju
authors.initials: M
authors.lastname: Mathews
authors.affiliation: Forest Research Institute (an affiliate of Actavis Inc.), Jersey City, New Jersey; at time of studies.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Forero
authors.affiliation: Forest Research Institute (an affiliate of Actavis Inc.), Jersey City, New Jersey; at time of studies.
authors.forename: Rene
authors.initials: R
authors.lastname: Nunez
authors.affiliation: Forest Research Institute (an affiliate of Actavis Inc.), Jersey City, New Jersey.
authors.forename: Xiongwen
authors.initials: X
authors.lastname: Tang
authors.affiliation: Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Michael E
authors.initials: ME
authors.lastname: Thase
mesh_terms: D000328:Adult; D001008:Anxiety Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D000069503:Vilazodone Hydrochloride / Q000627:therapeutic use*
chemical_list: D017367:Selective Serotonin Reuptake Inhibitors; D000069503:Vilazodone Hydrochloride
keywords: antidepressant; anxiety/anxiety disorders; clinical trials; generalized anxiety disorder; pharmacotherapy