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Efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in depression with anhedonia: a single-arm, multi-center clinical study

Efficacy and safety of toludesvenlafaxine hydrochloride sustained-release tablets in depression with anhedonia: a single-arm, multi-center clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070331
Enrollment
Unknown
Registered
2023-04-10
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

treatment group:oral drug administration

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 ~ 65 years (including borderline values), regardless of gender. 2. Meeting DSM-5 diagnostic criteria for depression and current depressive episode in accordance with the Mini-International Neuropsychiatric Interview 7.0 (MINI 7.0). 3. A total score of MADRS =26. 4. A total score of DARS (Chinese version) =28.5 5. No antidepressants or mood stabilizers in the last 2 weeks, no benzodiazepines or other sleep aids in the last 3 days, and no fluoxetine or vortioxetine in the last 1 month. 6. Subjects voluntarily participated in this trial and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy or known allergy to venlafaxine or desvenlafaxine. 2. Those whose previous treatment with venlafaxine have failed , or whose treatment with at least 2 different types of antidepressants are ineffective. 3. Persons with severe self-injury, significant suicidal attempts or behaviors, with a MADRS entry 10 (suicidal ideation) score = 4 4. Pregnant or lactating women, recent planned pregnancy and use of contraceptives 5. Consistent with a DSM-5 diagnosis of any disorder other than depression 6. Substance related or alcohol use disorders (excluding nicotine or caffeine) meeting DSM-5 diagnostic criteria within 6 months before screening 7. Persons with depressive episodes secondary to other psychiatric or somatic disorders 8. Persons with a history of seizures (except convulsions caused by pediatric febrile convulsions) 9. Total bilirubin (TBIL) values 1.5 times higher than the upper limit of normal, alanine aminotransferase (ALT) or glutamic oxalacetic aminotransferase (AST) 2 times higher than the upper limit of normal, creatinine (Cr) 1.2 times higher than the upper limit of normal, and thyroid stimulating hormone (TSH) outside the normal range at screening. 10. Electrocardiogram (ECG) abnormalities that are clinically significant at the time of screening and that the investigator considers inappropriate for inclusion, such as QTc interval > 470 ms in men and QTc interval > 480 ms in women. 11. Those who have participated in other clinical trials within 3 months prior to screening. 12. Other serious acute or chronic diseases, psychiatric disorders, or abnormal laboratory examination have clinical significance , and the investigator has judged that the subject is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
DARS;SHAPS;

Secondary

MeasureTime frame
SDS;Q-LES-Q-SF;MADRS;

Countries

China

Contacts

Public ContactLu Lin

Peking University Sixth Hospital

linlu@bjmu.edu.cn+86 13801027748

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026