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A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder

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收录情况： ◇ SCIE

作者：
Mi Weifeng[1] ; Di Xiaolan[2] ; Wang Yiming[3] ; Li Huafang[4] ; Xu Xiufeng[5] ; Li Lehua[6] ; Wang Huaning[7] ; Wang Guoqiang[8] ; Zhang Kerang[9] ; Tian Feng[10] ; Luo Jiong[11] ; Yang Chanjuan[12] ; Zhou Yunfei[13] ; Xie Shiping[14] ; Zhong Hua[15] ; Wu Bin[16] ; Yang Dong[17] ; Chen Zhenhua[18] ; Li Yi[19] ; Chen Jindong[20] ; Lv Shuyun[21] ; Yi Qizhong[22] ; Jiang Zhiwei[23] ; Tian Jingwei[24] ; Zhang Hongyan[1] ;
机构： [1]Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China. [2]Beijing Huilongguan Hospital, Beijing, China. [3]The Affiliated Hospital of Guizhou Medical University, Guizhou, China. [4]Shanghai Mental Health Center, Shanghai, China. [5]First Affiliated Hospital of Kunming Medical University, Kunming, China. [6]Second Xiangya Hospital of Central South University, Changsha, China. [7]First Affiliated Hospital of the Fourth Military Medical University of Chinese People's Liberation Army, Xi'an, China. [8]Wuxi Mental Health Center, Wuxi, China. [9]First Hospital of Shanxi Medical University, Taiyuan, China. [10]Second Hospital of Shanxi Medical University, Taiyuan, China. [11]Beijing Anding Hospital of Capital Medical University, Beijing, China. [12]The Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China. [13]Shenzhen Kangning Hospital, Shenzhen, China. [14]Nanjing Brain Hospital, Nanjing, China. [15]Huzhou Third Municipal Hospital, Huzhou, China. [16]Xi 'an Mental Health Center, Xi'an, China. [17]Hunan Brain Hospital, Changsha, China. [18]Renmin Hospital of Wuhan University, Wuhan, China. [19]Wuhan Mental Health Center, Wuhan, China. [20]Xiamen Xianyue Hospital, Xiamen, China. [21]The Fourth People Hospital of Urumqi, Urumqi, China. [22]The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China. [23]Beijing KeyTech Statistical Technology Co., Ltd, Beijing, China. [24]Yantai University, Yantai, China
出处：
DOI： 10.1038/s41398-023-02435-0
ISSN：

摘要：
Major depressive disorder (MDD) is the most prevalent form of depression and is becoming a great challenge for public health and medical practice. Although first-line antidepressants offer therapeutic benefits, about 35% of depressed patients are not adequately treated, creating a substantial unmet medical need. A multicenter, double-blind, randomized, placebo-controlled phase 3 clinical trial was conducted in patients with MDD in China to assess the efficacy and safety of ansofaxine (LY03005), a potential triple reuptake inhibitor of serotonin, norepinephrine, and dopamine. Eligible 588 MDD patients were included and randomly assigned (1:1:1) to 8-week treatment with ansofaxine 80 mg/day(n = 187), ansofaxine 160 mg/day(n = 186), or placebo(n = 185). The primary efficacy endpoint was the Montgomery-Åsberg Depression Rating Scale (MADRS) total score change from baseline to the end of the study. Safety indexes included adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram (ECG), and evaluation of suicide tendency and sexual function. Significant differences were found in mean changes in MADRS total score at week 8 in the two ansofaxine groups (80 mg, -20.0; 160 mg, -19.9) vs. placebo (-14.6; p < 0.0001). All doses of ansofaxine were generally well-tolerated. Treatment-emergent adverse events (TEAEs) were reported by 137 (74.46%) patients in ansofaxine 80 mg group, 144 (78.26%) patients in ansofaxine 160 mg and 125 (67.93%) patients in the placebo group. The incidence of treatment-related adverse events (TRAEs) was 59.2% (109 patients), 65.22% (120 patients) in the 80, 160 mg ansofaxine groups, and 45.11% (83 patients) in the placebo group. The initial results of this trial indicate that ansofaxine at both the 80 mg/day and 160 mg/day was effective and safe in adult patients with MDD. ClinicalTrials.gov Identifier: NCT04853407.© 2023. The Author(s).

基金：
National Science and Technology (no. 2009ZX09103-100, 2013ZX09402201-002, 2017GSF218106, 2018ZX09303015, and 2021ZD0204004).
语种：
外文
被引次数：
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出版当年[2024]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 精神病学
JCR分区：
出版当年[2023]版：
Q1 PSYCHIATRY
最新[2023]版：
Q1 PSYCHIATRY

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

第一作者：
第一作者机构： [1]Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Mi Weifeng,Di Xiaolan,Wang Yiming,et al.A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder[J].TRANSLATIONAL PSYCHIATRY.2023,13(1):doi:10.1038/s41398-023-02435-0.
APA：
Mi Weifeng,Di Xiaolan,Wang Yiming,Li Huafang,Xu Xiufeng...&Zhang Hongyan.(2023).A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder.TRANSLATIONAL PSYCHIATRY,13,(1)
MLA：
Mi Weifeng,et al."A phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to verify the efficacy and safety of ansofaxine (LY03005) for major depressive disorder".TRANSLATIONAL PSYCHIATRY 13..1(2023)

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