Somatic SymptomPhase 4NCT05849272
Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression
A Phase 4 study testing toludesvenlafaxine hydrochloride sustained-release tablets in people with Somatic Symptom, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Somatic Symptom
- What is being tested?
- toludesvenlafaxine hydrochloride sustained-release tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 8 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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;
- 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;
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: 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.
Read the 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.
- Conditions
- Somatic Symptom
- Being tested
- toludesvenlafaxine hydrochloride sustained-release tablets
- Keywords
- medical treatment, somatic symptom, depression
- Medical subject headings
- Medically Unexplained Symptoms, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toludesvenlafaxine hydrochloride sustained-release tabletsDrug
orally once a day
| Study group | Role | What they receive |
|---|---|---|
| Toludesvenlafaxine hydrochloride sustained-release tablets 80-160 mg group | Experimental | orally once a day Receives: Drug: toludesvenlafaxine hydrochloride sustained-release tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 8 Weeks
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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).
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start12 May 2023
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatic SymptomStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849272
- Sponsor's protocol ID
- SMHC-DSS-001
- Status last verified
- May 2025
- First submitted
- 23 Apr 2023
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40661857
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Toluedesvenlafaxine Hydrochloride Extended-release Tablets in Somatic Symptoms of Depression: a Prospective, Single-arm, Multicenter Study
- ClinicalTrials.gov ID
- NCT05849272
- Acronym / sponsor ID
- SMHC-DSS-001
- Conditions
- Somatic Symptom
- Keywords
- medical treatment, somatic symptom, depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toludesvenlafaxine hydrochloride sustained-release tablets 80-160 mg group | Experimental | Drug: toludesvenlafaxine hydrochloride sustained-release tabletsorally once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| toludesvenlafaxine hydrochloride sustained-release tabletsorally once a day | Drug | Toludesvenlafaxine hydrochloride sustained-release tablets 80-160 mg group |
Primary outcome
Patient Health Questionnaire-15 (PHQ-15)
Time frame: 8 Weeks
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).
The Chinese version of the Somatization Symptom Scale (SSS-CN)
Time frame: 8 Weeks
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).
3 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 8 Weeks
Multidimensional Fatigue Index (MFI-20)
Time frame: 8 Weeks
Sheehan Disability Scale (SDS)
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Derived from this study: PubMed 40661857Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing toludesvenlafaxine hydrochloride sustained-release tablets in people with Somatic Symptom, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-15 (PHQ-15) (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05849272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.