Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-Release Tablets on Somatic Symptoms of Major Depressive Disorder: A Prospective, Single-Arm, Multicenter Clinical Study

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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

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