title: Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone.
abstract: OBJECTIVE
  To investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD).
  
  
  METHODS
  Three randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) were pooled for analyses; data were collected from June 2012 to March 2014. Post hoc outcomes in the pooled intent-to-treat population (n = 1,462) included mean change from baseline to week 8 in Hamilton Anxiety Rating Scale (HARS) total score, psychic and somatic anxiety subscale scores, and individual item scores; HARS response (≥ 50% total score improvement) and remission (total score ≤ 7) at week 8; and category shifts, defined as HARS item score ≥ 2 at baseline (moderate to very severe symptoms) and score of 0 at week 8 (no symptoms).
  
  
  RESULTS
  The least squares mean difference was statistically significant for vilazodone versus placebo in change from baseline to week 8 in HARS total score (-1.83, P < .0001) and in psychic anxiety (-1.21, P < .0001) and somatic anxiety (-0.63, P < .01) subscale scores; differences from placebo were significant on 11 of 14 HARS items (P < .05). Response rates were higher with vilazodone than placebo (48% vs 39%, P < .001), as were remission rates (27% vs 21%, P < .01). The percentage of patients who shifted to no symptoms was significant for vilazodone on several items: anxious mood, tension, intellectual, depressed mood, somatic-muscular, somatic-sensory, cardiovascular, respiratory, and autonomic symptoms (P < .05).
  
  
  CONCLUSIONS
  Treatment with vilazodone versus placebo was effective in adult GAD patients, with significant differences between treatment groups found on both psychic and somatic HARS items.
  
  
  BACKGROUND
  ClinicalTrials.gov identifiers: NCT01629966, NCT01766401, NCT01844115.
authors.affiliation: Northwest Clinical Research Center, Bellevue, Washington; Duke University School of Medicine, Department of Psychiatry, Durham, North Carolina.
authors.forename: Arif
authors.initials: A
authors.lastname: Khan
authors.affiliation: Forest Research Institute, an Allergan affiliate, Jersey City, New Jersey.
authors.forename: Suresh
authors.initials: S
authors.lastname: Durgam
authors.affiliation: Forest Research Institute, an Allergan affiliate, Jersey City, New Jersey.
authors.forename: Xiongwen
authors.initials: X
authors.lastname: Tang
authors.affiliation: Prescott Medical Communications Group, Chicago, Illinois.
authors.forename: Adam
authors.initials: A
authors.lastname: Ruth
authors.affiliation: Forest Research Institute, an Allergan affiliate, Jersey City, New Jersey.
authors.forename: Maju
authors.initials: M
authors.lastname: Mathews
authors.affiliation: Forest Research Institute, an Allergan affiliate, Jersey City, New Jersey.
authors.forename: Carl P
authors.initials: CP
authors.lastname: Gommoll
mesh_terms: D000328:Adult; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome; D000069503:Vilazodone Hydrochloride / Q000627:therapeutic use*
chemical_list: D014151:Anti-Anxiety Agents; D000069503:Vilazodone Hydrochloride