title: Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial.
abstract: OBJECTIVE
  To evaluate the efficacy, safety, and tolerability of vilazodone as an acute treatment for generalized anxiety disorder (GAD). Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist approved for the treatment of major depressive disorder in adults.
  
  
  METHODS
  This was a randomized, placebo-controlled, parallel-group, multicenter, flexible-dose study conducted from May 2013-March 2014. Adult patients (18-70 years, inclusive) who met DSM-IV-TR criteria for GAD were randomized (1:1) to placebo or vilazodone 20-40 mg/d for 8 weeks of double-blind treatment. Primary and secondary efficacy parameters were change from baseline to week 8 in the Hamilton Anxiety Rating Scale (HARS) total score and in the Sheehan Disability Scale (SDS) total score, respectively, analyzed using a mixed-effects model for repeated measures approach on a modified intent-to-treat population. Safety outcomes were summarized descriptively.
  
  
  RESULTS
  Efficacy analyses were based on 400 patients (placebo = 200, vilazodone = 200); 76% completed the study (placebo = 81%, vilazodone = 71%). The least squares mean difference (95% CI) in total score change from baseline to week 8 was statistically significant for vilazodone versus placebo on the HARS (-2.20 [-3.72 to -0.68]; P = .0048) and on the SDS (-1.89 [-3.52 to -0.26]; P = .0236). Treatment-emergent adverse events reported in ≥ 5% of vilazodone patients and at least twice the rate of placebo were nausea, diarrhea, dizziness, fatigue, delayed ejaculation, and erectile dysfunction.
  
  
  CONCLUSIONS
  Statistically significant differences in favor of vilazodone 20-40 mg/d versus placebo were seen on all measures of anxiety and functional impairment in patients with GAD. Vilazodone was generally well tolerated, and no new safety concerns were noted.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01844115.
authors.affiliation: Forest Research Institute, Harborside Financial Center, Jersey City, NJ 07311. suresh.durgam@actavis.com.|Forest Research Institute, an affiliate of Actavis, Inc, Jersey City, New Jersey, USA.
authors.forename: Suresh
authors.initials: S
authors.lastname: Durgam
authors.affiliation: Forest Research Institute, an affiliate of Actavis, Inc, Jersey City, New Jersey, USA.
authors.forename: Carl
authors.initials: C
authors.lastname: Gommoll
authors.affiliation: Forest Research Institute, an affiliate of Actavis, Inc, Jersey City, New Jersey, USA.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Forero
authors.affiliation: Forest Research Institute, an affiliate of Actavis, Inc, Jersey City, New Jersey, USA.
authors.forename: Rene
authors.initials: R
authors.lastname: Nunez
authors.affiliation: Forest Research Institute, an affiliate of Actavis, Inc, Jersey City, New Jersey, USA.
authors.forename: Xiongwen
authors.initials: X
authors.lastname: Tang
authors.affiliation: Forest Research Institute, an affiliate of Actavis, Inc, Jersey City, New Jersey, USA.
authors.forename: Maju
authors.initials: M
authors.lastname: Mathews
authors.affiliation: Distinguished University Health Professor Emeritus, University of South Florida College of Medicine, Tampa, Florida, USA.
authors.forename: David V
authors.initials: DV
authors.lastname: Sheehan
mesh_terms: D000328:Adult; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D001008:Anxiety Disorders / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D018490:Serotonin Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000069503:Vilazodone Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D014151:Anti-Anxiety Agents; D018490:Serotonin Agents; D000069503:Vilazodone Hydrochloride