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

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

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.

Study Overview

• Status: Completed
• Conditions: Somatic Symptom
• Intervention / Treatment: Drug: toludesvenlafaxine hydrochloride sustained-release tablets

Detailed Description

The study included 60 patients (aged 18 to 65 years) who meet the diagnostic criteria for depression in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and who are accompanied by physical symptoms.

All enrolled subjects were given toludesvenlafaxine hydrochloride sustained-release tablets monotherapy for 8 weeks, followed up at period of enrollment as baseline and at the end of 2th, 4th and 8th weeks. Adverse events were recorded.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Allergic or known to be allergic to venlafaxine and desvenlafaxine;
2. Subjects whose previous treatment with venlafaxine have failed, or whose previous treatment with at least 2 different types of antidepressants are ineffective;
3. 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;
4. 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;
5. Subject has a severe self-injury/clear suicide attempt or behavior;
6. With blood pressure > 140/90 mmHg
7. 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;
8. Electrocardiogram (ECG) abnormalities that are clinically significant at period of screening and that the investigator considers as inappropriate conditions for inclusion, such as QTc interval > 470 ms in men and QTc interval > 480 ms in female;
9. 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;
10. Pregnant or lactating women, recent planned pregnancy and unable to ensure effective contraception during the period;
11. Other conditions that the investigator considers the participant is not suitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Toludesvenlafaxine hydrochloride sustained-release tablets 80-160 mg group; orally once a day	Drug: toludesvenlafaxine hydrochloride sustained-release tablets; orally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS)	The VAS is a validated, subjective measure for acute and chronic pain. The total score range of 0 -10 (from no pain to worst pain).	8 Weeks
Multidimensional Fatigue Index (MFI-20)	The MFI-20 has a 20-item checklist, consist of 5 subscales. Items are rated on a scale of 1-5, for a total score range of 20 -100 (high scores represent more fatigue) and each subscale range of 4-20.	8 Weeks
Sheehan Disability Scale (SDS)	The SDS has a 5-item checklist. The total scores range of 0 -30 (from no impairment to highly impairment of function of normal life).	8 Weeks

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2023
• Primary Completion (Actual): May 8, 2024
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: depression; medical treatment; somatic symptom
• Additional Relevant MeSH Terms: Behavioral Symptoms; Medically Unexplained Symptoms; Depression
• Other Study ID Numbers: SMHC-DSS-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No