Evidence map›Paper›PMID 40661857›Full record

Trial reportNeuropsychiatric disease and treatment2025

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

Yun Wang, Mengxin He, Huifeng Zhang, Yanli Luo, Xia Sun, Zhijian Yao, Hao Tang, Rui Yan, Xiangdong Du, Zhe Li and 2 more

Registry-linked trialAbstract readCase ReportsClinical Trial
In one paragraph

Trial report in Neuropsychiatric disease and treatment, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05849272 (Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05849272 phase4completednot on this map

Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression: a Prospective, Single-arm, Multicenter Study

TypeinterventionalSponsorShanghai Mental Health CenterRan2023 to 2024Enrolled60ConditionsSomatic SymptomArmstoludesvenlafaxine hydrochloride sustained-release tablets
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Yun Wang *Mood Disorders Department, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Mengxin He *Psychology Department, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Huifeng ZhangMood Disorders Department, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Yanli LuoPsychology Department, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Xia SunPsychology Department, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Zhijian YaoPsychiatry Department, Nanjing Brain Hospital, Nanjing University School of Medicine, Nanjing, People's Republic of China.
Hao TangPsychiatry Department, Nanjing Brain Hospital, Nanjing University School of Medicine, Nanjing, People's Republic of China.
Rui YanPsychiatry Department, Nanjing Brain Hospital, Nanjing University School of Medicine, Nanjing, People's Republic of China.
Xiangdong DuPsychiatry Department, Suzhou Guangji Hospital, Suzhou, People's Republic of China.
Zhe LiPsychiatry Department, Suzhou Guangji Hospital, Suzhou, People's Republic of China.
Daihui PengMood Disorders Department, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.ORCID 0000-0003-4338-967X
Zhen WangMood Disorders Department, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.ORCID 0000-0003-4319-5314

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 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, 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. Clinicaltrialsgov Identifier: NCT05849272.

Indexed as

clinical trialefficacymajor depressive disordersafetysomatic symptomstoludesvenlafaxine

Identifiers

PMID40661857
PMCPMC12256775

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.