title: The effect of vortioxetine on overall patient functioning in patients with major depressive disorder.
abstract: The objectives of this meta-analysis of data from randomized, placebo-controlled studies were to assess the effect of vortioxetine on overall functioning (primary) and functional remission (secondary) using the Sheehan Disability Scale (SDS) in adults with major depressive disorder (MDD).
  
  
  
  Data from nine short-term (6/8 weeks) pivotal studies that included patient functioning assessments were included in this random-effects meta-analysis, which used aggregated study-level data for all therapeutic vortioxetine doses and a mixed-effect model for repeated measures using the full analysis set.
  
  
  
  A total of 4,216 patients received ≥1 dose of study treatment (1,522 placebo, 2,694 vortioxetine 5-20 mg/day). At study end, the meta-analysis showed improvement for vortioxetine versus placebo (n= 911) in SDS total score (vortioxetine 5 mg,n=564, change from baseline versus placebo [Δ] -0.24,p= NS; 10 mg,n=445, Δ -1.68,p≤.001; 15 mg,n=204, Δ -0.91,p= NS; 20 mg,n=340, Δ -1.94,p≤.01). Functional remission (SDS total score ≤6) was observed with vortioxetine 10 mg (n=170/573; odds ratio [OR] relative to placebo 1.7,p<.001) and 20 mg (n=144/447; OR 1.6,p<.05), but not 5 mg (n=207/757; OR 1.1,p= NS) or 15 mg (n=92/295; OR 1.3,p= NS).
  
  
  
  Vortioxetine 5-20 mg for 6/8 weeks improved overall patient functioning in patients with MDD. Relative to placebo, vortioxetine 10 and 20 mg demonstrated significant improvement in SDS total score and functional remission.
authors.affiliation: H. Lundbeck A/S Copenhagen Denmark.
authors.forename: Ioana
authors.initials: I
authors.lastname: Florea
authors.affiliation: H. Lundbeck A/S Copenhagen Denmark.
authors.forename: Henrik
authors.initials: H
authors.lastname: Loft
authors.affiliation: Lundbeck SAS Issy-les-Moulineaux France.
authors.forename: Natalya
authors.initials: N
authors.lastname: Danchenko
authors.affiliation: Lundbeck SAS Issy-les-Moulineaux France.
authors.forename: Benoît
authors.initials: B
authors.lastname: Rive
authors.affiliation: Lundbeck SAS Issy-les-Moulineaux France.
authors.forename: Melanie
authors.initials: M
authors.lastname: Brignone
authors.affiliation: Takeda Development Center Americas Deerfield IL USA.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Merikle
authors.affiliation: Takeda Development Center Americas Deerfield IL USA.
authors.forename: Paula L
authors.initials: PL
authors.lastname: Jacobsen
authors.affiliation: University of South Florida College of Medicine Tampa FL USA.
authors.forename: David V
authors.initials: DV
authors.lastname: Sheehan
mesh_terms: D000328:Adult; D003865:Major Depressive Disorder / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000706:statistics & numerical data*; D010879:Piperazines / Q000008:administration & dosage / Q000494:pharmacology*; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000494:pharmacology*; D013440:Sulfides / Q000008:administration & dosage / Q000494:pharmacology*; D000078784:Vortioxetine
chemical_list: D010879:Piperazines; D017367:Selective Serotonin Reuptake Inhibitors; D013440:Sulfides; D000078784:Vortioxetine
keywords: Sheehan Disability Scale; functional impairment; major depressive disorder; quality of life; vortioxetine