Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression

NCT05849272 | Completed Phase 4

• 1 other identifier: SMHC-DSS-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in the treatment of somatic symptoms in depression, to provide evidence-based basis for clinical rational drug use.

Conditions

Somatic Symptom

Keywords

medical treatment; somatic symptom; depression

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire-15 (PHQ-15)

  The PHQ-15 has a 15-item checklist. Items are rated on a scale of 0-2, for a total score range of 0 -30 (scores ≥ 5, ≥10, ≥15 represent mild, moderate and severe levels of somatization).

  8 Weeks

• The Chinese version of the Somatization Symptom Scale (SSS-CN)

  The SSS-CN has a 20-item checklist. Items are rated on a scale of 1-4, for a total score range of 20-80 (scores between 20-29, 30-39, 40-59, ≥60 correspond normal, mild, moderate and severe levels of somatic symptom disorder).

  8 Weeks

Secondary Outcomes (3)

• Visual Analog Scale (VAS)

  8 Weeks

• Multidimensional Fatigue Index (MFI-20)

  8 Weeks

• Sheehan Disability Scale (SDS)

  8 Weeks

Study Arms (1)

Toludesvenlafaxine hydrochloride sustained-release tablets 80-160 mg group

EXPERIMENTAL

orally once a day

Drug: toludesvenlafaxine hydrochloride sustained-release tablets

Interventions

toludesvenlafaxine hydrochloride sustained-release tablets DRUG

orally once a day

Toludesvenlafaxine hydrochloride sustained-release tablets 80-160 mg group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meet the Diagnostic and Statistical Manual of Manual Disorders, fifth Edition (DSM-5) criteria for depression;
• Male or female aged ≥18 and ≤65 years;
• Subject has a Hamilton Depression Rating Scale (HAMD-17) total score \>17, anxiety/somatization factor ≥ 3;
• Subject has a total score of Patient Health Questionnaire-15 (PHQ-15) ≥5;
• Subject has a clear consciousness, no serious intellectual impairment, ability to speak autonomously, and no obvious symptoms of dementia;
• Subjects voluntarily participate in the study and sign the informed consent form

You may not qualify if:

• Allergic or known to be allergic to venlafaxine and desvenlafaxine;
• Subjects whose previous treatment with venlafaxine have failed, or whose previous treatment with at least 2 different types of antidepressants are ineffective;
• Subjects meet the diagnostic criteria for other psychotic disorders (except for depression) in DSM-5, personality disorders or intellectual disability, substance disorders or drug abuse within previous 6 months;
• Subjects meet the diagnostic criteria for clinically significant unstable diseases, such as hepatic insufficiency or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatic, immune, infectious, skin and subcutaneous tissue diseases or metabolic disorders;
• Subject has a severe self-injury/clear suicide attempt or behavior;
• With blood pressure \> 140/90 mmHg
• Total bilirubin (TBIL) values 1.5 times / alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2 times / creatinine (Cr) 1.2 times higher than the upper limit of normal, or Thyroid-stimulating hormone (TSH) outside the normal range at screening;
• Subject has a history of moderate or severe brain trauma (for example, loss of consciousness ≥1 hour) or other neurological disorders or systemic diseases, which may affect the neurological function of CNS;
• Pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period;
• Other conditions that the investigator considers the participant is not suitable for the study

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (1)

• Wang Y, He M, Zhang H, Luo Y, Sun X, Yao Z, Tang H, Yan R, Du X, Li Z, Peng D, Wang Z. Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-Release Tablets on Somatic Symptoms of Major Depressive Disorder: A Prospective, Single-Arm, Multicenter Clinical Study. Neuropsychiatr Dis Treat. 2025 Jul 9;21:1387-1397. doi: 10.2147/NDT.S513481. eCollection 2025.

  PMID: 40661857 DERIVED

MeSH Terms

Conditions

Medically Unexplained Symptoms; Depression

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 8, 2023
• Study Start: May 12, 2023
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)