title: Clinical relevance of vilazodone treatment in patients with major depressive disorder: categorical improvement in symptoms.
abstract: OBJECTIVE
  To assess clinically relevant symptom improvement in patients with major depressive disorder (MDD) receiving vilazodone by using the Montgomery-Asberg Depression Rating Scale (MADRS), a clinician-rated scale used to measure MDD symptom severity and improvement.
  
  
  METHODS
  Pooled data from 2 positive, phase 3, 8-week, double-blind, randomized, placebo-controlled trials in patients with MDD were analyzed. Patients received vilazodone 40 mg/d or placebo; post hoc analyses were conducted on study completers. Depression symptom improvement was evaluated by analyzing the proportions of patients who shifted from the baseline MADRS single-item symptom severity category of ≥ 2 (mild to severe symptoms) to an end-of-study category < 2 (minimal to no symptoms) or from ≥ 4 (moderate to severe symptoms) to ≤ 2 (mild to no symptoms). The proportion of patients who shifted from anxious depression to no anxious depression was also analyzed.
  
  
  RESULTS
  The percentage of patients who completed these studies with severity category shift from baseline ≥ 2 to end of study < 2 was significantly higher for vilazodone versus placebo on all MADRS items (odds ratio [OR] range, 1.4-1.7, P < .05) except reduced appetite (OR = 1.3, P = .232). A significantly greater proportion of vilazodone-treated versus placebo-treated patients shifted from baseline ≥ 4 to end of study ≤ 2 on MADRS items of apparent sadness, reported sadness, inner tension, reduced sleep, and lassitude (OR range, 1.5-2.0, P < .05). Additionally, a significantly greater proportion of vilazodone-treated versus placebo-treated patients shifted from anxious depression at baseline to no anxious depression at end of study (OR = 1.5, P = .031).
  
  
  CONCLUSIONS
  These results suggest that vilazodone treatment is associated with clinically relevant changes in depression symptoms in patients with MDD.
  
  
  BACKGROUND
  ClinicalTrials.gov identifiers: NCT00285376 and NCT00683592.
authors.affiliation: Department of Family Medicine, Boston University School of Medicine, Boston, Massachusetts (Dr Culpepper); and Departments of Clinical Development (Dr Mathews), Biostatistics (Dr Ghori), and Medical Affairs (Dr Edwards), Forest Research Institute, Jersey City, New Jersey.
authors.forename: Larry
authors.initials: L
authors.lastname: Culpepper
authors.affiliation: Department of Family Medicine, Boston University School of Medicine, Boston, Massachusetts (Dr Culpepper); and Departments of Clinical Development (Dr Mathews), Biostatistics (Dr Ghori), and Medical Affairs (Dr Edwards), Forest Research Institute, Jersey City, New Jersey.
authors.forename: Maju
authors.initials: M
authors.lastname: Mathews
authors.affiliation: Department of Family Medicine, Boston University School of Medicine, Boston, Massachusetts (Dr Culpepper); and Departments of Clinical Development (Dr Mathews), Biostatistics (Dr Ghori), and Medical Affairs (Dr Edwards), Forest Research Institute, Jersey City, New Jersey.
authors.forename: Razi
authors.initials: R
authors.lastname: Ghori
authors.affiliation: Department of Family Medicine, Boston University School of Medicine, Boston, Massachusetts (Dr Culpepper); and Departments of Clinical Development (Dr Mathews), Biostatistics (Dr Ghori), and Medical Affairs (Dr Edwards), Forest Research Institute, Jersey City, New Jersey.
authors.forename: John
authors.initials: J
authors.lastname: Edwards