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

NCT07785284

Not Yet RecruitingNA

Sponsor: Peking University

Conditions: Outpatients or Inpatients With Depression

Interventions: Shugan Jieyu Capsules

Countries: China

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 overview

Sex: ALL

Age: 13 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (1)

Beijing, China