Yun Wang,1,* Mengxin He,2,* Huifeng Zhang,1 Yanli Luo,2 Xia Sun,2 Zhijian Yao,3 Hao Tang,3 Rui Yan,3 Xiangdong Du,4 Zhe Li,4 Daihui Peng,1 Zhen Wang1 

1Mood Disorders Department, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 2Psychology Department, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 3Psychiatry Department, Nanjing Brain Hospital, Nanjing University School of Medicine, Nanjing, People’s Republic of China; 4Psychiatry Department, Suzhou Guangji Hospital, Suzhou, People’s Republic of China

*These authors contributed equally to this work

Correspondence: Daihui Peng, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wan Ping Road, Shanghai, 200030, People’s Republic of China, Email pdhsh@126.com Zhen Wang, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, 600 South Wan Ping Road, Shanghai, 200030, People’s Republic of China, Email wangzhen@smhc.org.cn

Importance: Depression is a significant global public health issue, with somatic symptoms being a common and challenging aspect of its management.
Objective: This study aimed to evaluate the efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets (Roxylin®) for somatic symptoms of major depressive disorder (MDD).
Design, Setting, and Participants: 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.
Intervention: All participants received toludesvenlafaxine hydrochloride monotherapy for 8 weeks.
Main Outcomes and Measures: 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.
Results: 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, P < 0.001) and SSS-CN scores (− 12.8 ± 10.3, P < 0.001), indicating improvement in somatic symptoms. Secondary outcomes also showed significant improvements in depressive symptoms (HAMD-17: − 15.3 ± 7.4, P < 0.001), pain intensity (VAS: − 1.97 ± 2.44, P < 0.001), fatigue (MFI-20: − 12.8 ± 14.1, P < 0.001), and functional disability (SDS: − 8.3 ± 6.5, P < 0.001). The occurrence of adverse events was 52.5%, with no serious adverse events reported.
Conclusion: 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.
Clinicaltrials.gov Identifier: NCT05849272.

Keywords: major depressive disorder, somatic symptoms, toludesvenlafaxine, clinical trial, safety, efficacy