Wang Yun, He Mengxin, Zhang Huifeng, Luo Yanli, Sun Xia, Yao Zhijian, Tang Hao, Yan Rui, Du Xiangdong, Li Zhe, Peng Daihui, Wang Zhen
Mood Disorders Department, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Psychology Department, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Neuropsychiatr Dis Treat. 2025 Jul 9;21:1387-1397. doi: 10.2147/NDT.S513481. eCollection 2025.
Depression is a significant global public health issue, with somatic symptoms being a common and challenging aspect of its management.
This study aimed to evaluate the efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets (Roxylin) for somatic symptoms of major depressive disorder (MDD).
Prospective, single-arm, multicenter clinical study conducted between June 1, 2023 and May 1, 2024, enrolling patients diagnosed with MDD with somatic symptoms at four hospitals across China.
All participants received toludesvenlafaxine hydrochloride monotherapy for 8 weeks.
The primary outcomes were improvements in somatic depression symptoms measured by PHQ-15 and SSS-CN at baseline and weeks 2, 4, and 8, while secondary outcomes included changes in depressive symptoms (HAMD-17), pain intensity (VAS), fatigue (MFI-20), and functional impairment (SDS), with adverse events monitored.
Out of 72 screened patients, 61 were enrolled. The mean age of the participants was 30.1 ± 9.0 years, ranging from 18 to 53 years, with 29.6% being male and 70.4% female. After 8 weeks of treatment, significant reductions were observed in PHQ-15 scores (-5.8 ± 4.4, < 0.001) and SSS-CN scores (-12.8 ± 10.3, < 0.001), indicating improvement in somatic symptoms. Secondary outcomes also showed significant improvements in depressive symptoms (HAMD-17: -15.3 ± 7.4, < 0.001), pain intensity (VAS: -1.97 ± 2.44, < 0.001), fatigue (MFI-20: -12.8 ± 14.1, < 0.001), and functional disability (SDS: -8.3 ± 6.5, < 0.001). The occurrence of adverse events was 52.5%, with no serious adverse events reported.
Toludesvenlafaxine hydrochloride significantly improved somatic symptoms in patients with MDD and somatic symptoms, with a favorable safety profile, supporting its use as an effective treatment option.
NCT05849272.
抑郁症是一个重大的全球公共卫生问题，躯体症状是其治疗中常见且具有挑战性的一个方面。
本研究旨在评估盐酸托度文拉法辛缓释片（Roxylin）治疗重度抑郁症（MDD）躯体症状的疗效和安全性。
设计、地点和参与者：2023年6月1日至2024年5月1日进行的一项前瞻性、单臂、多中心临床研究，在中国四家医院招募被诊断为伴有躯体症状的MDD患者。
所有参与者接受盐酸托度文拉法辛单药治疗8周。
主要结局是通过PHQ - 15和SSS - CN在基线、第2周、第4周和第8周测量的躯体抑郁症状的改善情况，次要结局包括抑郁症状（HAMD - 17）、疼痛强度（VAS）、疲劳（MFI - 20）和功能损害（SDS）的变化，并监测不良事件。
在72名筛查患者中，61名被纳入研究。参与者的平均年龄为30.1±9.0岁，年龄范围为18至53岁，男性占29.6%，女性占70.4%。治疗8周后，观察到PHQ - 15评分（-5.8±4.4，P<0.001）和SSS - CN评分（-12.8±10.3，P<0.001）显著降低，表明躯体症状有所改善。次要结局也显示抑郁症状（HAMD - 17：-15.3±7.4，P<0.001）、疼痛强度（VAS：-1.97±2.44，P<0.001）、疲劳（MFI - 20：-12.8±14.1，P<0.001）和功能残疾（SDS：-8.3±6.5，P<0.001）有显著改善。不良事件发生率为52.5%，未报告严重不良事件。
盐酸托度文拉法辛显著改善了伴有躯体症状的MDD患者的躯体症状，且安全性良好，支持其作为一种有效的治疗选择。
NCT05849272。
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