PMID- 17592906
OWN - NLM
STAT- MEDLINE
DCOM- 20070719
LR  - 20190902
IS  - 1555-2101 (Electronic)
IS  - 0160-6689 (Linking)
VI  - 68
IP  - 6
DP  - 2007 Jun
TI  - Efficacy and tolerability of once-daily extended release quetiapine fumarate in 
      acute schizophrenia: a randomized, double-blind, placebo-controlled study.
PG  - 832-42
AB  - OBJECTIVE: To evaluate the efficacy and tolerability of extended release 
      quetiapine fumarate (quetiapine XR) in a 6-week, double-blind, randomized study. 
      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 > or = 30% reduction in total score), Clinical Global 
      Impressions-Improvement scale (CGI-I) response rate (percentage of patients with 
      score < or = 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. 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. 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.
FAU - Kahn, Rene S
AU  - Kahn RS
AD  - Department of Psychiatry, Rudolf Magnus Institute of Neuroscience, University 
      Medical Center, Utrecht, The Netherlands. rkahn@umcutrecht.nl
FAU - Schulz, S Charles
AU  - Schulz SC
FAU - Palazov, Veselin D
AU  - Palazov VD
FAU - Reyes, Efren B
AU  - Reyes EB
FAU - Brecher, Martin
AU  - Brecher M
FAU - Svensson, Ola
AU  - Svensson O
FAU - Andersson, Henrik M
AU  - Andersson HM
FAU - Meulien, Didier
AU  - Meulien D
CN  - Study 132 Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00206115
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychiatry
JT  - The Journal of clinical psychiatry
JID - 7801243
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Dibenzothiazepines)
RN  - 2S3PL1B6UJ (Quetiapine Fumarate)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Antipsychotic Agents/*administration & dosage
MH  - Delayed-Action Preparations
MH  - Dibenzothiazepines/*administration & dosage
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Quetiapine Fumarate
MH  - Schizophrenia/*drug therapy
MH  - Treatment Outcome
EDAT- 2007/06/27 09:00
MHDA- 2007/07/20 09:00
CRDT- 2007/06/27 09:00
PHST- 2007/06/27 09:00 [pubmed]
PHST- 2007/07/20 09:00 [medline]
PHST- 2007/06/27 09:00 [entrez]
AID - 10.4088/jcp.v68n0603 [doi]
PST - ppublish
SO  - J Clin Psychiatry. 2007 Jun;68(6):832-42. doi: 10.4088/jcp.v68n0603.