%0 Journal Article
%T Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: A randomized, double-blind, placebo-controlled study
%J Journal of clinical psychiatry
%D 2007
%A Kahn, R.S.
%A Schulz, S.C.
%A Palazov, V.D.
%A Reyes, E.B.
%A Brecher, M.
%A Svensson, O.
%A Andersson, H.M.
%A Meulien, D.
%V 68
%N 6
%P 832-842
%X OBJECTIVE: To evaluate the efficacy and tolerability of extended release quetiapine fumarate (quetiapine XR) in a 6-week, double-blind, randomized study. <br><br>METHOD: Patients with a DSM-IV diagnosis of acute schizophrenia were randomly assigned to fixed-dose quetiapine XR 400, 600, or 800 mg/day (once daily in the evening), quetiapine immediate release (IR) 400 mg/day (200 mg twice daily), or placebo. Dual-matched placebo was used to maintain blinding. Quetiapine XR target doses were reached by day 2 (400 and 600 mg) and day 3 (800 mg). The primary endpoint was least squares mean change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score. PANSS response rate (percentage of patients with ≥ 30% reduction in total score), Clinical Global Impressions-Improvement scale (CGI-I) response rate (percentage of patients with score ≤ 3), change in CGI-Severity of Illness (CGI-S), and adverse events (AEs) were also assessed. The study was conducted from November 2004 to December 2005. <br><br>RESULTS: 588 patients were enrolled and 446 (76%) completed the study. Improvement in PANSS total score at week 6 was significant versus placebo (-18.8) in all groups: -24.8 (p =.03), -30.9 (p <.001), and -31.3 (p <.001) for quetiapine XR 400, 600, and 800 mg, respectively, and -26.6 (p =.004) for quetiapine IR. There were also statistically significant differences in PANSS and CGI-I response rates for all active treatments versus placebo (all p <.05). The most common AEs in all quetiapine groups were somnolence and dizziness; there were no unexpected AEs with quetiapine XR. Incidence of AEs potentially related to extrapyramidal symptoms was similar to placebo. <br><br>CONCLUSION: Once-daily quetiapine XR (400-800 mg/day) was effective versus placebo in patients with acute schizophrenia. Treatment, including rapid dose escalation, was well tolerated, with a therapeutically effective dose reached by day 2. Clinical Trials Registration: ClinicalTrials.gov identifier NCT00206115.<p /><p>Language: en</p>
%G en
%I Physicians Postgraduate Press
%@ 0160-6689
%U http://dx.doi.org/10.4088/JCP.v68n0603