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Not Yet Recruiting NCT07785284

A Multicenter Real-World Study Evaluating the Efficacy and Safety of Shugan Jieyu Capsules in the Treatment of Depression

Conditions: Outpatients or Inpatients With Depression

Sex: All
Ages: 13 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 400
Sponsor: Peking University

Location: Institute of Mental Health, Peking University Sixth Hospital Beijing

Summary

To observe the efficacy and safety of Shugan Jieyu Capsules in treating patients with varying degrees of depression in real-world clinical settings, and to provide data references for optimizing integrated traditional Chinese and Western medicine treatment strategies.

Eligibility Criteria

Inclusion Criteria: 1. Meet the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5); 2. Aged 13-65 years (inclusive), male or female; 3. No antidepressants taken within at least 14 days before screening (patients who have received fluoxetine treatment must have discontinued it for at least 28 days before screening); 4. Voluntarily sign the informed consent form and comply with all study visits, examinations, and treatments as required by the protocol. Exclusion Criteria: 1. Treatment-resistant depression (poor clinical response to adequate doses and durations of two or more antidepressants with different mechanisms, or poor clinical response to adequate doses and durations of antidepressant TCMs) or depression induced by psychoactive substances; 2. Patients who meet the diagnostic criteria for other mental disorders in the DSM-5 (such as schizophrenia spectrum disorders, bipolar disorder); 3. Patients with serious suicidal tendencies (HAMD-17 item 3 score ≥ 3) or homicidal tendencies; 4. Patients with severe or unstable cardiovascular, cerebrovascular, hepatic, renal, endocrine, digestive, hematological, or other medical conditions; 5. Known or suspected history of allergy to Hypericum perforatum or Eleutherococcus senticosus; 6. Pregnant or breastfeeding women; 7. Patients currently receiving treatment with any other investigational drug; 8. Other patients who are not suitable for participation in this clinical trial.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07785284). StuddyBuddy aggregates publicly available trial information.