title: Effects of once-daily extended release quetiapine fumarate (quetiapine XR) on quality of life and sleep in elderly patients with major depressive disorder.
abstract: BACKGROUND
  Major depressive disorder (MDD) is frequently associated with reduced quality of life (QoL) and sleep disturbance. We investigated the effects of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy on QoL and sleep in elderly patients with MDD.
  
  
  METHODS
  Prospectively planned analysis of patient-reported data from an 11-week (9-week randomized; 2-week post-treatment), double-blind, placebo-controlled, Phase III study. Elderly patients (≥66 years; DSM-IV MDD; Hamilton Rating Scale for Depression [HAM-D] total score ≥22, HAM-D Item 1 score ≥2) were randomized to quetiapine XR (flexible dosing 50-300 mg/day) or placebo.
  
  
  METHODS
  MADRS total score change from randomization at Week 9. Patient-reported outcomes: Quality of Life, Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) % of maximum total score (Items 1-14), Q-LES-Q-SF Item 15 ('satisfaction with medication'), Q-LES-Q-SF Item 16 ('overall life satisfaction'), and Pittsburgh Sleep Quality Index (PSQI) global score.
  
  
  RESULTS
  In total, 338 patients were randomized (166 quetiapine XR; 172 placebo). At Week 9, quetiapine XR significantly reduced MADRS total score (-16.33; difference: -7.54; 95% CI: -9.23, -5.85; p<0.001) versus placebo (-8.79). Quetiapine XR significantly improved Q-LES-Q-SF % of maximum total score (16.86; difference: 7.69; 95% CI: 4.99, 10.39; p<0.001) versus placebo (9.17), with numerical improvement in Q-LES-Q-SF Item 15 and improvement in Item 16. Improvement in PSQI global score was observed with quetiapine XR (-6.42; difference: -3.52; 95% CI: -4.26, -2.79; p<0.001) versus placebo (-2.89).
  
  
  CONCLUSIONS
  Lack of active-comparator arm, flexible-dose design, acute treatment period.
  
  
  CONCLUSIONS
  Quetiapine XR monotherapy improved QoL and sleep in elderly patients with MDD.
authors: AstraZeneca Pharmaceuticals, Wilmington, DE, USA. julie.locklear@astrazeneca.com
authors: Julie C
authors: JC
authors: Locklear
authors: Henrik
authors: H
authors: Svedsäter
authors: Catherine
authors: C
authors: Datto
authors: Jean
authors: J
authors: Endicott
mesh_terms: D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage*; D003692:Delayed-Action Preparations; D003865:Major Depressive Disorder / Q000150:complications / Q000188:drug therapy*; D003987:Dibenzothiazepines / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011788:Quality of Life; D000069348:Quetiapine Fumarate; D012890:Sleep / Q000187:drug effects; D012893:Sleep Wake Disorders / Q000188:drug therapy* / Q000209:etiology
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate