title: Efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) monotherapy in patients with generalised anxiety disorder: an analysis of pooled data from three 8-week placebo-controlled studies.
abstract: OBJECTIVE
  Prospectively planned pooled analysis evaluating efficacy and tolerability of acute quetiapine XR monotherapy in generalised anxiety disorder.
  
  
  METHODS
  Data from three 10-week, randomised, double-blind, placebo-controlled studies of similar design were analysed.
  
  
  RESULTS
  At Week 8, Hamilton Anxiety Rating Scale (HAM-A) total score significantly improved with quetiapine XR: least squares means change -13.31, p < 0.001 (50 mg/day, n = 452), -14.39, p < 0.001 (150 mg/day, n = 673) and -12.50, p < 0.05 (300 mg/day, n = 444) versus -11.30 placebo; significant (p < 0.001, n = 665) improvements versus placebo were observed with each dose at Week 1. Significant improvements versus placebo at Week 8 are as follows: HAM-A psychic symptom subscale, Montgomery-Åsberg Depression Rating Scale total, Pittsburgh Sleep Quality Index global scores for all quetiapine XR doses; HAM-A response and remission rates, HAM-A somatic symptom subscale score, Clinical Global Impression-Severity of Illness total score, % patients with Clinical Global Impression-Improvement score ≤2 with quetiapine XR 50 and 150 mg/day; and Quality of Life Enjoyment and Satisfaction Questionnaire short form % maximum total score with quetiapine XR 150 mg/day. In the quetiapine XR 50, 150 and 300 mg/day and placebo groups, 13.2%, 16.5%, 24.0% and 5.4% of patients discontinued because of an adverse event, and 1.9%, 1.4%, 3.7% and 1.8% of patients experienced clinically significant changes in glucose. The most common adverse events with quetiapine XR included dry mouth, somnolence, sedation and constipation.
  
  
  CONCLUSIONS
  Quetiapine XR monotherapy reduced the symptoms of generalised anxiety disorder, with improvement from Week 1. Adverse events were consistent with the known tolerability profile of quetiapine.
authors.affiliation: Department of Psychiatry, University of Cape Town, Cape Town, South Africa. dan.stein@uct.ac.za
authors.forename: Dan J
authors.initials: DJ
authors.lastname: Stein
authors.forename: Borwin
authors.initials: B
authors.lastname: Bandelow
authors.forename: Charles
authors.initials: C
authors.lastname: Merideth
authors.forename: Bengt
authors.initials: B
authors.lastname: Olausson
authors.forename: Johan
authors.initials: J
authors.lastname: Szamosi
authors.forename: Hans
authors.initials: H
authors.lastname: Eriksson
mesh_terms: D000328:Adult; D001008:Anxiety Disorders / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology*; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D003987:Dibenzothiazepines / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000069348:Quetiapine Fumarate; D013223:Statistics as Topic / Q000379:methods; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate