title: Efficacy and safety of vilazodone in major depressive disorder: a randomized, double-blind, placebo-controlled trial.
abstract: BACKGROUND
  Vilazodone is a potent serotonin (5-HT) reuptake inhibitor and 5-HT₁A receptor partial agonist approved by the US Food and Drug Administration for the treatment of major depressive disorder (MDD) in adults. This study evaluated the efficacy and tolerability of vilazodone in the treatment of MDD.
  
  
  METHODS
  This 8-week, randomized (1:1), double-blind, placebo-controlled, parallel-group, fixed-dose study conducted from January 2012 to February 2013 compared vilazodone 40 mg/d with placebo in outpatients with DSM-IV-TR-diagnosed MDD. The primary efficacy measure was Montgomery-Asberg Depression Rating Scale (MADRS) total score change from baseline to week 8 analyzed by a mixed-effects model for repeated measures on the intent-to-treat population (placebo = 252, vilazodone = 253). Secondary efficacy outcomes were Clinical Global Impressions-Severity of Illness (CGI-S) Scale score change from baseline and MADRS sustained response rate (total score ≤ 12 for at least the last 2 consecutive double-blind visits).
  
  
  RESULTS
  Approximately 83% of patients completed the study. Least squares mean differences (95% CI) were statistically significant for vilazodone versus placebo on MADRS (-5.117 [-6.886 to -3.347], P < .00001) and CGI-S (-0.622 [-0.845 to -0.399], P < .00001) change from baseline; statistically significant improvements versus placebo occurred at week 2 and persisted for the study duration. The MADRS sustained response rate was 17% for placebo and 27% for vilazodone (P < .01). Patients taking vilazodone versus placebo had higher rates of diarrhea and nausea; most incidences were mild in severity. Weight increase and sexual dysfunction adverse events were low in both groups.
  
  
  CONCLUSIONS
  A large and significant treatment effect on the MADRS and statistically significant improvement on the CGI-S demonstrated meaningful depressive symptom improvements. Vilazodone was generally well tolerated.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01473394.
authors.affiliation: 7434 Louis Pasteur, Ste 101, San Antonio, TX 78229 hacroft@drcroft.com.
authors.forename: Harry A
authors.initials: HA
authors.lastname: Croft
authors.forename: Nunzio
authors.initials: N
authors.lastname: Pomara
authors.forename: Carl
authors.initials: C
authors.lastname: Gommoll
authors.forename: Dalei
authors.initials: D
authors.lastname: Chen
authors.forename: Rene
authors.initials: R
authors.lastname: Nunez
authors.forename: Maju
authors.initials: M
authors.lastname: Mathews
mesh_terms: D000328:Adult; D001572:Benzofurans / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D016896:Treatment Outcome; D000069503:Vilazodone Hydrochloride; D055815:Young Adult
chemical_list: D001572:Benzofurans; D007211:Indoles; D010879:Piperazines; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D000069503:Vilazodone Hydrochloride