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A multicenter, randomized, double-blind, duloxetine-controlled, non-inferiority trial of desvenlafaxine succinate extended-release in patients with major depressive disorder

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资源类型：
Pubmed体系：
作者：
Zhao Qian[1] ; Fu Bingbing[1] * ; Lyu Nan[1] * ; Xu Xiangdong[2] ; Huang Guangbiao[3] ; Tan Yunlong[4] ; Xu Xiufeng[5] ; Zhang Xuehua[6] ; Wang Xueyi[7] ; Wang Zhiqiang[8] ; Li Keqing[9] ; Hu ZhenYu[10] ; Li Hengfen[11] ; He Hongbo[12] ; Li Shuang[13] ; Zhao Jingyuan[14] ; He Ruifeng[15] ; Guo Hua[16] ; Li Yi[17] ; Li Lehua[18] ; Yang Chuang[19] ; Zou Shaohong[20] ; Wei Bo[21] ; Wang Wenqiang[22] ; Chen Ce[23] ; Lu Zheng[24] ; He Shunqiang[25] ; Wang Qian[25] ; Zhao Jinghua[25] ; Pan Xiaoyue[25] ; Pan Zhenyu[25] ; Li Junqing[25] ; Wang Gang[1,*1] ;
机构： [1]The National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China. [2]Department of Psychiatry, The Fourth People's Hospital of Urumqi, Urumqi, China. [3]Department of Psychiatry, Huzhou Third Municipal Hospital, Huzhou, China. [4]Psychiatry Research Center, Beijing Huilongguan Hospital, Beijing, China. [5]Department of Psychiatry, The First Affiliated Hospital of Kunming Medical University, Kunming, China. [6]Hunan Brain Hospital (Hunan Second Municipal Hospital), Changsha, China. [7]Department of Psychiatry, The First Hospital of Hebei Medical University, Shijiazhuang, China. [8]Department of Psychiatry, Wuxi Mental Health Center, Wuxi, China. [9]Department of Psychiatry, Mental Health Center of Hebei Province, Baoding, China. [10]Department of Psychiatry, Ningbo Kangning Hospital, Ningbo, China. [11]Department of Psychiatry, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. [12]Department of Psychiatry, The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou Mental Health, Guangzhou, China. [13]Dalian Seventh People's Hospital, Dalian, China. [14]Department of Psychiatry, Henan Mental Hospital, The Second Affiliated Hospital of Xinxiang Medical University, Xinxiang, China. [15]The Mental Health Center of Xi'an, Xi'an, China. [16]Zhumadian Psychiatric Hospital, Zhumadian, China. [17]Wuhan Mental Health Center, Wuhan, China. [18]Department of Psychiatry, The Second Xiangya Hospital of Central South University, Changsha, China. [19]Department of Psychiatry, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China. [20]Department of Clinical Psychology, People's Hospital of Xinjiang Uygur Autonomous Region, Urumqi, Xinjiang, China. [21]Department of Psychiatry, Jiangxi Mental Hospital, Affiliated Mental Hospital of Nanchang University, Nanchang, China. [22]Xiamen Xianyue Hospital, Xiamen, China. [23]Department of Psychiatry, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [24]Department of Psychiatry, Tongji Hospital of Tongji University, Shanghai, China. [25]Clincal sciences division, CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Co., Ltd, Shijiazhuang, China.
出处：
DOI： 10.1016/j.jad.2023.02.067
ISSN：

关键词： Desvenlafaxine Duloxetine Major depressive disorder Non-inferiority 17-item Hamilton Depression Rating Scale

摘要：
Desvenlafaxine and duloxetine are selective serotonin and norepinephrine reuptake inhibitors. Their efficacy has not been directly compared using statistical hypotheses. This study evaluated the non-inferiority of desvenlafaxine extended-release (XL) to duloxetine in patients with major depressive disorder (MDD).In this study, 420 adult patients with moderate-to-severe MDD were enrolled and randomly assigned (1:1) to receive 50 mg (once daily [QD]) of desvenlafaxine XL (n = 212) or 60 mg QD of duloxetine (n = 208). The primary endpoint was evaluated using a non-inferiority comparison based on the change from baseline to 8 weeks in the 17-item Hamilton Depression Rating Scale (HAMD17) total score. Secondary endpoints and safety were evaluated.Least-squares mean change in HAM-D17 total score from baseline to 8 weeks was -15.3 (95 % confidence interval [CI]: -17.73, -12.89) in the desvenlafaxine XL group and - 15.9 (95 % CI, -18.44, -13.39) in the duloxetine group. The least-squares mean difference was 0.6 (95 % CI: -0.48, 1.69), and the upper boundary of 95 % CI was less than the non-inferiority margin (2.2). No significant between-treatment differences were found in most secondary efficacy endpoints. The incidence of the most common treatment-emergent adverse events (TEAEs) was lower for desvenlafaxine XL than for duloxetine for nausea (27.2 % versus 48.8 %) and dizziness (18.0 % versus 28.8 %).A short-term non-inferiority study without a placebo arm.This study demonstrated that desvenlafaxine XL 50 mg QD was non-inferior to duloxetine 60 mg QD in efficacy in patients with MDD. Desvenlafaxine had a lower incidence of TEAEs than duloxetine did.Copyright © 2023. Published by Elsevier B.V.

基金：
CSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. sponsored this study. CSPC collected and analysed the data and contributed to the interpretation of the study. Additionally, the study was supported by Sci-Tech Innovation 2030 - Major Project of Brain science and brain-inspired intelligence technology (2021ZD0200600), Beijing Municipal Health Commission of Beijing demonstration research ward (BCRW202009), Beijing Hospitals Authority Clinical Medicine Development of special funding support (XMLX202128), and Beijing Municipal Administration of Hospitals Incubating Program (PX2022076).
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2024]版：
无
最新[2023]版：
大类 | 2 区 医学
小类 | 2 区 临床神经病学 2 区 精神病学
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, Beijing, China.
共同第一作者：
通讯作者：
通讯机构： [1]The National Clinical Research Center for Mental Disorders, Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China. [*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.
推荐引用方式(GB/T 7714)：
Zhao Qian,Fu Bingbing,Lyu Nan,et al.A multicenter, randomized, double-blind, duloxetine-controlled, non-inferiority trial of desvenlafaxine succinate extended-release in patients with major depressive disorder[J].Journal of affective disorders.2023,doi:10.1016/j.jad.2023.02.067.
APA：
Zhao Qian,Fu Bingbing,Lyu Nan,Xu Xiangdong,Huang Guangbiao...&Wang Gang.(2023).A multicenter, randomized, double-blind, duloxetine-controlled, non-inferiority trial of desvenlafaxine succinate extended-release in patients with major depressive disorder.Journal of affective disorders,,
MLA：
Zhao Qian,et al."A multicenter, randomized, double-blind, duloxetine-controlled, non-inferiority trial of desvenlafaxine succinate extended-release in patients with major depressive disorder".Journal of affective disorders .(2023)

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