title: A randomized, controlled study comparing the effects of vestipitant or vestipitant and paroxetine combination in subjects with tinnitus.
abstract: OBJECTIVE
  Tinnitus is a common symptom that demonstrates a significant comorbidity with anxiety and depression. The novel neurokinin-1 receptor antagonist, vestipitant, has anxiolytic properties and a good safety profile. Vestipitant was investigated for potential effect against chronic tinnitus as a stand-alone treatment and in conjunction with a selective serotonin reuptake inhibitor, paroxetine.
  
  
  METHODS
  Randomized, double-blind, crossover study.
  
  
  METHODS
  Tertiary neurotologic and audiologic center with additional referrals from a secondary university hospital center.
  
  
  METHODS
  Twenty-four adult patients with tinnitus were randomized into the study.
  
  
  METHODS
  Visual analogue scale (VAS) measurements of tinnitus loudness (intensity), pitch and distress, VAS measurements of arousal/anxiety, Tinnitus Handicap Inventory, Quick Inventory of Depressive Symptomatology, and plasma concentrations of trial drugs.
  
  
  RESULTS
  No statistically significant treatment benefit effect was detected for tinnitus (intensity, pitch, and distress) VAS scores, arousal-anxiety VAS scores, Tinnitus Handicap Inventory, or tinnitus aggravation scores assessed on Days 1 and 14. However, a statistically significant worsening of tinnitus intensity and distress scores was observed after vestipitant compared with placebo for the mean data collected over the treatment period. No relevant differences in vestipitant plasma concentrations were observed between the subjects given the combination with paroxetine and those receiving vestipitant alone. No specific relationships were observed between tinnitus intensity and vestipitant plasma concentrations.
  
  
  CONCLUSIONS
  Although well-tolerated vestipitant, alone or in combination with paroxetine, was not effective in ameliorating tinnitus in this patient group.
authors.affiliation: Clinical Pharmacology Science and Study Operations, Neuroscience Centre of Excellence in Drug Discovery GlaxoSmithKline, Harlow, UK. Claire.roberts67@gmail.com
authors.forename: Claire
authors.initials: C
authors.lastname: Roberts
authors.forename: Amir
authors.initials: A
authors.lastname: Inamdar
authors.forename: Annelize
authors.initials: A
authors.lastname: Koch
authors.forename: Pauline
authors.initials: P
authors.lastname: Kitchiner
authors.forename: Odile
authors.initials: O
authors.lastname: Dewit
authors.forename: Emilio
authors.initials: E
authors.lastname: Merlo-Pich
authors.forename: Paolo
authors.initials: P
authors.lastname: Fina
authors.forename: Don J
authors.initials: DJ
authors.lastname: McFerran
authors.forename: David M
authors.initials: DM
authors.lastname: Baguley
mesh_terms: D018592:Cross-Over Studies; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005464:Fluorobenzenes; D006801:Humans; D008297:Male; D008875:Middle Aged; D064729:Neurokinin-1 Receptor Antagonists; D017374:Paroxetine / Q000627:therapeutic use*; D010880:Piperidines / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D014012:Tinnitus / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D005464:Fluorobenzenes; D064729:Neurokinin-1 Receptor Antagonists; D017374:Paroxetine; D010880:Piperidines; D017367:Selective Serotonin Reuptake Inhibitors; C534550:vestipitant