title: Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: a randomized, placebo-controlled trial in clinically stable patients.
abstract: BACKGROUND
  This long-term, randomized, double-blind, placebo-controlled study examined the efficacy of extended release quetiapine fumarate (quetiapine XR) in preventing psychotic relapse in schizophrenia.
  
  
  METHODS
  Three hundred twenty-seven clinically stable patients with schizophrenia were switched to open-label quetiapine XR (300mg on Day 1, 600mg on Day 2, followed by flexible dosing [400-800mg/day]) for a 16-week stabilization phase. Thereafter, patients who were clinically stable for four months were randomized to flexible doses of quetiapine XR (400-800mg/day) or placebo. Primary endpoint was time to first schizophrenia relapse after randomization. Secondary endpoints included risk of relapse at six months. Interim analyses were planned after 45 and 60 relapses and final analysis after 90 relapses. Maximal treatment time was one year.
  
  
  RESULTS
  The study was terminated after the first interim analysis showed a significant difference between randomized treatment groups. Time to relapse was significantly longer in quetiapine XR-treated patients versus placebo (hazard ratio 0.16 [95% confidence interval 0.08, 0.34]; p=0.001). Fewer quetiapine XR-treated patients relapsed versus those receiving placebo (10.7% vs. 41.4%, respectively). Estimated risk of relapse at six months was significantly lower with quetiapine XR (14.3%) compared with placebo (68.2%; p=0.0001). The incidence of treatment-related adverse events (AEs) was similar between quetiapine XR and placebo groups (18% and 21% of patients, respectively) and only one percent of patients in each group withdrew because of AEs.
  
  
  CONCLUSIONS
  Once-daily quetiapine XR (400-800mg/day) was effective in preventing relapse in patients with clinically stable schizophrenia. Quetiapine XR was well tolerated during longer-term use.
authors.affiliation: Dr. Peuskens is with Universitair Psychiatrisch Centrum KU Leuven, Campus St Jozef Kortenberg, Belgium.
authors.forename: Joseph
authors.initials: J
authors.lastname: Peuskens
authors.forename: Jitendra
authors.initials: J
authors.lastname: Trivedi
authors.forename: Sergiy
authors.initials: S
authors.lastname: Malyarov
authors.forename: Martin
authors.initials: M
authors.lastname: Brecher
authors.forename: Ola
authors.initials: O
authors.lastname: Svensson
authors.forename: Frank
authors.initials: F
authors.lastname: Miller
authors.forename: Inger
authors.initials: I
authors.lastname: Persson
authors.forename: Didier
authors.initials: D
authors.lastname: Meulien