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Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study.

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收录情况： ◇ SCIE

作者：
Xiao Le[1] ; Zhao Qian[1] ; Li An-Ning[1] ; Sun Jushui[2] ; Wu Bin[3] ; Wang Lina[4] ; Zhang Honggeng[5] ; Zhang Ruiling[6] ; Li Keqing[7] ; Xu Xiaojin[8] ; Liu Tiebang[9] ; Zhang Wenshun[9] ; Xie Shiping[10] ; Xu Xiufeng[11] ; Tan Yunlong[12] ; Zhang Kerang[13] ; Zhang Hongyan[14] ; Guan Nianhong[15] ; Xian Mingji[16] ; Uki Motomichi[17] ; Wang Gang[1] ;
机构： [1]The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Dewai Avenue, Xicheng District, Beijing, 100088, China. [2]Huzhou Third Municipal Hospital, Huzhou, China. [3]Xi'an Mental Health Center, Xi'an, China. [4]Tianjin Mental Health Centre, Tianjin Anding Hospital, Tianjin, China. [5]Brain Hospital of Hunan Province, Changsha, China. [6]Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China. [7]Hebei Provincial Mental Health Center, Baoding, China. [8]Wuhan Mental Health Center, Wuhan, China. [9]Shenzhen Mental Health Center, Shenzhen, China. [10]Nanjing Brain Hospital, Nanjing, China. [11]First Affiliated Hospital of Kunming Medical University, Kunming, China. [12]Beijing Huilongguan Hospital, Beijing, China. [13]First Hospital of Shanxi Medical University, Taiyuan, China. [14]Peking University Sixth Hospital, Beijing, China. [15]The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China. [16]Clinical Development, Otsuka Beijing Research Institute, Beijing, China. [17]Division of Otsuka International Asia & Arab, Otsuka Pharmaceutical Co., Ltd, Tokyo, Japan
出处：
DOI： 10.1007/s00213-021-06044-x
ISSN：

摘要：
The present study aimed to evaluate the efficacy and safety of aripiprazole once-monthly (AOM) compared to oral aripiprazole in treating acute schizophrenia.This randomized, double-blind, non-inferiority study recruited patients from 15 trial sites across China from May 2017 to April 2019. Patients with an acute psychotic episode received AOM at 400 mg or oral aripiprazole at 10-20 mg for 12 weeks. The primary and secondary efficacy endpoints were the difference in scores from baseline to week 10, as assessed on the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impressions-Severity (CGI-S) scores, respectively.A total of 436 patients were randomized. Among them, 159/218 (72.9%) and 165/218 (75.7%) in the AOM and oral aripiprazole groups completed 10 weeks of treatment, respectively. The least-squares (LS) mean changes from baseline to endpoint (week 10) in PANSS were - 33.6 for the AOM group and - 34.8 in the oral aripiprazole group, respectively, with a difference of - 1.2 (95% CI: - 4.1, 1.7). The non-inferiority margin of AOM to oral aripiprazole was - 4.1, which was above the lower limit of the pre-defined margin. The altered CGI-S score was - 2.2 and - 2.3 in the AOM and oral aripiprazole groups, respectively. The incidence of treatment-emergent adverse events (TEAEs) was similar in both groups. The rate of discontinuation due to TEAEs was 2.3% and 3.2% in the AOM and oral aripiprazole groups, respectively.This study confirmed the efficacy and safety of AOM for the treatment of Chinese patients with acute schizophrenia. The non-inferiority of AOM to oral aripiprazole was established, with comparable efficacy and tolerability. These findings suggested that AOM could be used as a treatment option for patients experiencing an acute episode of schizophrenia.ClinicalTrials.gov identifier: NCT03172871.© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.

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中科院(CAS)分区：
出版当年[2023]版：
大类 | 3 区 医学
小类 | 3 区 神经科学 3 区 药学 3 区 精神病学
最新[2023]版：
大类 | 3 区 医学
小类 | 3 区 神经科学 3 区 药学 3 区 精神病学
JCR分区：
出版当年[2022]版：
Q2 NEUROSCIENCES Q2 PHARMACOLOGY & PHARMACY Q3 PSYCHIATRY
最新[2023]版：
Q2 NEUROSCIENCES Q2 PHARMACOLOGY & PHARMACY Q2 PSYCHIATRY

影响因子： 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, No. 5 Ankang Lane, Dewai Avenue, Xicheng District, Beijing, 100088, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Xiao Le,Zhao Qian,Li An-Ning,et al.Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study.[J].PSYCHOPHARMACOLOGY.2022,239(1):243-251.doi:10.1007/s00213-021-06044-x.
APA：
Xiao Le,Zhao Qian,Li An-Ning,Sun Jushui,Wu Bin...&Wang Gang.(2022).Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study..PSYCHOPHARMACOLOGY,239,(1)
MLA：
Xiao Le,et al."Efficacy and safety of aripiprazole once-monthly versus oral aripiprazole in Chinese patients with acute schizophrenia: a multicenter, randomized, double-blind, non-inferiority study.".PSYCHOPHARMACOLOGY 239..1(2022):243-251

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