title: Randomized, double-blind study of the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder.
abstract: OBJECTIVE
  This study assessed the efficacy and tolerability of once-daily extended release quetiapine fumarate (quetiapine XR) monotherapy in elderly patients with major depressive disorder (MDD).
  
  
  METHODS
  An 11-week (9-week randomized; 2-week posttreatment phase), double-blind, placebo-controlled, Phase III study (D1448C00014).
  
  
  METHODS
  A total of 53 centers in Argentina, Estonia, Finland, Russia, Ukraine, and the United States.
  
  
  METHODS
  A total of 338 patients (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnosis of MDD, age ≥66 years, Hamilton Rating Scale for Depression [HAM-D] total score ≥22, HAM-D Item 1 [depressed mood] score ≥2) were randomized (mean age: 71.3 years).
  
  
  METHODS
  Patients were randomized to quetiapine XR (n = 166; flexible-dosing 50-300 mg/day) or placebo (n = 172).
  
  
  METHODS
  Primary outcome was Montgomery Åsberg Depression Rating Scale (MADRS) total score change from randomization at Week 9.
  
  
  RESULTS
  At Week 9, quetiapine XR (least squares [LS] means: -16.33, standard error [SE]: 0.95; mean change: -16.0, standard deviation [SD]: 9.3) significantly reduced MADRS total score from randomization versus placebo (LS means [SE]: -8.79 [0.94]; mean [SD]: -9.0 [9.9]); significant improvements were also seen at Week 1 (LS means [SE]: -4.65 [0.53] versus -2.56 [0.53], respectively; mean [SD]: -4.3 [5.1] versus -2.4 [3.7], respectively). At Week 9, secondary outcome variables significantly improved with quetiapine XR versus placebo, including MADRS response (≥50% reduction in total score); MADRS remission (total score ≤8); HAM-D total, HAM-A total, HAM-A psychic and somatic cluster, and Clinical Global Impressions-Severity of Illness (CGI-S) total scores; proportion of patients with CGI-Improvement score of 2 or less; Q-LES-Q-SF% maximum total, Pittsburgh Sleep Quality Index global, and pain Visual Analog Scale scores. Common adverse events (>10% patients with quetiapine XR) were somnolence, headache, dry mouth, and dizziness.
  
  
  CONCLUSIONS
  In elderly patients with MDD, quetiapine XR monotherapy (50-300 mg/day, flexibly dosed) is effective at improving depressive symptoms, with symptom improvement observed as early as Week 1. Overall tolerability and safety were consistent with the known profile of quetiapine.
authors.affiliation: Department of Psychiatry, Helsinki University Central Hospital, Helsinki, Finland. Electronic address: heikki.katila@hus.fi.
authors.forename: Heikki
authors.initials: H
authors.lastname: Katila
authors.forename: Irina
authors.initials: I
authors.lastname: Mezhebovsky
authors.forename: Amy
authors.initials: A
authors.lastname: Mulroy
authors.forename: Lovisa
authors.initials: L
authors.lastname: Berggren
authors.forename: Hans
authors.initials: H
authors.lastname: Eriksson
authors.forename: Willie
authors.initials: W
authors.lastname: Earley
authors.forename: Catherine
authors.initials: C
authors.lastname: Datto
mesh_terms: D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations / Q000009:adverse effects / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000188:drug therapy*; D003987:Dibenzothiazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D000069348:Quetiapine Fumarate
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate
keywords: Atypical antipsychotic; elderly; extended release; major depressive disorder; quetiapine XR