title: Effects of extended-release quetiapine fumarate on long-term functioning and sleep quality in patients with Generalized Anxiety Disorder (GAD): data from a randomized-withdrawal, placebo-controlled maintenance study.
abstract: BACKGROUND
  This analysis evaluated effects of quetiapine XR maintenance treatment on functioning and sleep in patients with GAD.
  
  
  METHODS
  Analysis of patient-reported data from a randomized-withdrawal, double-blind, placebo-controlled study of quetiapine XR monotherapy in GAD. Following open-label run-in (4-8 weeks) and a 12-18-week stabilization phase (quetiapine XR 50, 150, or 300 mg/day), eligible patients were randomized to continue on quetiapine XR or receive placebo for up to 52 weeks. Primary variable was time to an anxiety event. Secondary variables included the Sheehan Disability Scale (SDS) and Pittsburgh Sleep Quality Index (PSQI).
  
  
  RESULTS
  In total, 432 patients were randomized (quetiapine XR, N=216; placebo, N=216). The risk of an anxiety event was significantly reduced for quetiapine XR vs. placebo (HR 0.19; 95% CI 0.12, 0.31; p<0.001). Quetiapine XR was more effective than placebo at maintaining SDS total scores (LSM change: -0.19 vs. 1.01; p=0.017) and non-work-related SDS domain score 'family life/home responsibilities' (-0.13 vs. 0.32; p=0.011), but not 'social life' (0.05 vs. 0.34; p=0.114). Quetiapine XR was more effective than placebo at maintaining the work-related SDS domain score 'days lost' (-0.05 vs. 0.11; p=0.027), but not 'work/school' (-0.10 vs. 0.29; p=0.051) or 'days underproductive' (0.06 vs. 0.13; p=0.619). PSQI global scores were reduced from randomization with quetiapine XR vs. placebo (0.39 vs. 1.60; p<0.001).
  
  
  CONCLUSIONS
  Lack of active-comparator arm, exclusion of patients with comorbid depression.
  
  
  CONCLUSIONS
  In patients with GAD, long-term treatment with quetiapine XR (50-300 mg/day) monotherapy was effective at maintaining improvements in functioning and sleep quality.
authors.affiliation: University of South Florida College of Medicine, Tampa, FL 33613, USA. Electronic address: dsheehan@health.usf.edu.
authors.forename: David V
authors.initials: DV
authors.lastname: Sheehan
authors.forename: Henrik
authors.initials: H
authors.lastname: Svedsäter
authors.forename: Julie C
authors.initials: JC
authors.lastname: Locklear
authors.forename: Hans
authors.initials: H
authors.lastname: Eriksson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001008:Anxiety Disorders / Q000188:drug therapy*; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D003987:Dibenzothiazepines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008875:Middle Aged; D000069348:Quetiapine Fumarate; D012890:Sleep / Q000187:drug effects*; D055815:Young Adult
chemical_list: D014151:Anti-Anxiety Agents; D003692:Delayed-Action Preparations; D003987:Dibenzothiazepines; D000069348:Quetiapine Fumarate
keywords: Functioning; Generalized anxiety disorder; Patient-reported outcomes; Quetiapine XR; Sleep quality