title: Early and sustained improvement with vilazodone in adult patients with major depressive disorder: post hoc analyses of two phase III trials.
abstract: OBJECTIVE
  To retrospectively examine the timing of depressive symptom improvement in patients treated with vilazodone, a selective serotonin reuptake inhibitor (SSRI) and 5-HT1A partial agonist.
  
  
  METHODS
  Post hoc analyses were conducted on pooled data from two phase III, multicenter, 8 week, double-blind, randomized, controlled trials (RCTs) of vilazodone 40 mg/day or placebo in adult patients with major depressive disorder (MDD).
  
  
  BACKGROUND
  Randomized controlled trial 1: ClinicalTrials.gov identifier: NCT00285376, http://ClinicalTrials.gov/ct2/show/NCT00285376 ; randomized controlled trial 2: ClinicalTrials.gov identifier: NCT00683592, http://ClinicalTrials.gov/ct2/show/NCT00683592.
  
  
  METHODS
  Montgomery-Åsberg Depression Rating Scale (MADRS) total score least squares (LS) mean change from baseline to Week 8; MADRS single items LS mean change from baseline; MADRS responder analyses: response = ≥50% reduction in baseline score; cumulative response = proportion of patients at each assessment who achieved response that was sustained at all subsequent weeks; sustained response = ≥50% reduction in baseline MADRS total score at last two visits; and sustained response plus MADRS score ≤12 at the last two visits of the study.
  
  
  RESULTS
  LS mean difference (LSMD) and 95% confidence interval (95% CI) for change from baseline to Week 8 was significantly greater in favor of vilazodone versus placebo (-2.8 [-4.1 to -1.4]; p < 0.0001); differences between vilazodone and placebo were statistically significant beginning at Week 1. Early improvement in depressive symptoms was suggested by statistically significant separation from placebo on seven of ten MADRS single items as early as Week 1 or Week 2. A significantly greater proportion of vilazodone patients achieved response using all responder criteria, with early and sustained improvement consistently observed.
  
  
  CONCLUSIONS
  Early and sustained improvement of depressive symptoms was retrospectively observed in patients treated with vilazodone; early findings may be related to overall treatment outcomes.
authors.affiliation: Associate Clinical Professor, Department of Psychiatry & Behavioral Sciences, University of Texas Medical School , Houston, TX , USA.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Jain
authors.forename: Dalei
authors.initials: D
authors.lastname: Chen
authors.forename: John
authors.initials: J
authors.lastname: Edwards
authors.forename: Maju
authors.initials: M
authors.lastname: Mathews
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001572:Benzofurans / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos / Q000008:administration & dosage; D012189:Retrospective Studies; D058825:Serotonin 5-HT1 Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000069503:Vilazodone Hydrochloride
chemical_list: D000928:Antidepressive Agents; D001572:Benzofurans; D007211:Indoles; D010879:Piperazines; D010919:Placebos; D058825:Serotonin 5-HT1 Receptor Agonists; D017367:Selective Serotonin Reuptake Inhibitors; D000069503:Vilazodone Hydrochloride