Efficacy and Safety of Ammoxetine in Major Depressive Disorder

作者：He Shen, Jing-Xu Chen, YU Xue-qin, Huali Lin, Zhiqiang Wang, X. Li, Yanan Zhou, Yan-Song Liu, Hongyan Zhang, Jicai Wang, Cuixia An, Hao Liu, Chao Li, Shaonan Ni, Huafang Li · 发表于：JAMA Network Open · 年份：2025 · DOI：10.1001/jamanetworkopen.2025.32650 · 被引用次数：4 · 研究领域：Treatment of Major Depression、Tryptophan and brain disorders、Cancer Research and Treatment

Importance: Major depressive disorder (MDD) is among the most prevalent mental health disorders, causing substantial disability and economic burden. Although several first-line treatments exist with mild adverse effects, up to 50% to 60% of patients do not tolerate or respond to them. Ammoxetine, a novel selective serotonin and norepinephrine reuptake inhibitor, has been found to reduce adverse effects and hepatotoxicity and more potent inhibition of serotonin and norepinephrine transporters, making it more tolerable and effective. Objective: To evaluate the efficacy and safety of ammoxetine in treating adults with MDD. Design, Setting, and Participants: This phase 2 randomized clinical trial was a multicenter, double-masked, placebo-controlled, parallel-group, fixed-dose study of ammoxetine treatment in patients with MDD in China. Patients aged 18 to 65 years from 15 study centers were randomized into daily ammoxetine or placebo groups between March 27, 2023, and June 13, 2024, and followed up for 10 weeks. Interventions: Participants were randomized 1:1:1 to 3 treatment groups: ammoxetine 40 mg/d, ammoxetine 60 mg/d, and placebo. Main Outcome and Measures: The primary outcome was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to 8 weeks. Efficacy analyses were performed on both the full-analysis and per-protocol sets using least-squares (LS) mean differences. The safety set analysis was performed using descriptive statistics. Results: ...