A 6-week, multicenter, double-blind, double-dummy, chlorpromazine-controlled non-inferiorityrandomized phase iiitrial to evaluate the efficacy and safety of quetiapine fumarate (SEROQUEL) extended-release (XR) in the treatment of patients with schizophrenia and acute episodes
机构：[1]Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China[2]Beijing Anding Hospital, Capital University of Medical Science, Beijing 100088, China[3]Xi’an Mental Health Center, Xi’an 710061, Shanxi, China[4]Guangzhou Brain Hospital, Guangzhou 510170, Guangdong, China[5]Nanjing Brain Hospital, Nanjing 210029, Jiangsu, China[6]Brains Hospital of Hunan Province, Changsha 410007, Hunan, China[7]Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China[8]Sixth Hospital of Hebei Province, Baoding 071000, Hebei, China[9]The First Affiliated Hospital of Kunming Medical College, Kunming 650032, Yunnan, China昆明医科大学附属第一医院云南省第一人民医院
This study aimed to evaluate the efficacy and safety of quetiapine fumarate extended-release (XR) in the treatment of Chinese patients with acute schizophrenia. Multicenter, double-blind, double-dummy, active-controlled non-inferiority randomized study in Chinese patients (n = 388) with schizophrenia randomly assigned to quetiapine XR or chlorpromazine for 6 weeks. Primary outcome was the change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment. Safety objectives included adverse event (AE) monitoring, laboratory test results, and electrocardiograms. Changes in PANSS total score were- 33.4 for quetiapine XR and -35.9 for chlorpromazine (P > 0.05). Least squares mean changes were: positive subscale, -9.9 +/- 0.53 and -11.1 +/- 0.51; negative subscale, -5.9 +/- 0.50 and -6.7 +/- 0.48; general psychopathology subscale, -12.9 +/- 0.74 and -13.9 +/- 0.71; aggression and hostility cluster scores, -4.8 +/- 0.33 and -5.4 +/- 0.32; and depression cluster scores, -1.8 +/- 0.18 and -1.7 +/- 0.18, for quetiapine XR and chlorpromazine, respectively. For quetiapine XR, AEs were constipation, dizziness, insomnia, and agitation, and nine patients (4.6%) discontinued due to AEs. For chlorpromazine, AEs were extrapyramidal symptoms, constipation, insomnia, dizziness, and agitation, and 17 patients (8.9%) discontinued due to AEs; two patients reported serious AEs. Quetiapine XR monotherapy was not inferior to chlorpromazine for treating acute schizophrenia in Chinese patients and was well tolerated.
基金：
AstraZenacaAstraZeneca; shanghai key laboratory of psychotic disorders [13dz2260500]; Collaborative Innovation Center for Translational Medicine at Shanghai Jiao Tong University School of Medicine [TM201506]; National Major Project for IND [2012ZX09303-003]
第一作者机构：[1]Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China
通讯作者：
推荐引用方式(GB/T 7714)：
Li Huafang,Shen Yifeng,Wang Gang,et al.A 6-week, multicenter, double-blind, double-dummy, chlorpromazine-controlled non-inferiorityrandomized phase iiitrial to evaluate the efficacy and safety of quetiapine fumarate (SEROQUEL) extended-release (XR) in the treatment of patients with schizophrenia and acute episodes[J].PSYCHIATRY RESEARCH.2018,259:117-124.doi:10.1016/j.psychres.2017.07.006.
APA：
Li, Huafang,Shen, Yifeng,Wang, Gang,Shi, Jianguo,Ma, Cui...&Gu, Niufan.(2018).A 6-week, multicenter, double-blind, double-dummy, chlorpromazine-controlled non-inferiorityrandomized phase iiitrial to evaluate the efficacy and safety of quetiapine fumarate (SEROQUEL) extended-release (XR) in the treatment of patients with schizophrenia and acute episodes.PSYCHIATRY RESEARCH,259,
MLA：
Li, Huafang,et al."A 6-week, multicenter, double-blind, double-dummy, chlorpromazine-controlled non-inferiorityrandomized phase iiitrial to evaluate the efficacy and safety of quetiapine fumarate (SEROQUEL) extended-release (XR) in the treatment of patients with schizophrenia and acute episodes".PSYCHIATRY RESEARCH 259.(2018):117-124
