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.
Meet the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
Aged 13-65 years (inclusive), male or female;
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);
Voluntarily sign the informed consent form and comply with all study visits, examinations, and treatments as required by the protocol.
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;
Patients who meet the diagnostic criteria for other mental disorders in the DSM-5 (such as schizophrenia spectrum disorders, bipolar disorder);
Patients with serious suicidal tendencies (HAMD-17 item 3 score ≥ 3) or homicidal tendencies;
Patients with severe or unstable cardiovascular, cerebrovascular, hepatic, renal, endocrine, digestive, hematological, or other medical conditions;
Single group
Shugan Jieyu Capsules
DrugMild depression (7\<HAMD-17≤17): Shugan Jieyu Capsules (SJC): 2 caps bid. At 4w: If HAMD-17 reduction rate (RR) \<20%, consider increasing SJC to 4 caps bid per guidelines. At 12w: ① If RR ≥50% or HAMD-17 ≤7, consider maintaining SJC for another 12w. ② If 20%≤RR\<50%, consider maintaining SJC, increasing to 4 caps bid, or combining other therapies. ③ If RR\<20%, consider increasing SJC to 4 caps bid, combining, or switching treatments. Moderate depression (18≤HAMD-17≤24): SJC 2 caps bid; or SJC + SSRI (SSRI at label/guideline dose). At 4w: Same as mild (increase to 4 caps bid if RR\<20%). At 12w: ①-③ Same as mild. ④ If efficacy met, consider discontinuing SSRI and continuing SJC based on stability. Severe depression (HAMD-17\>24): SJC + SSRI (SJC 2 caps bid; SSRI at label/guideline dose). At 4w: Same as above (increase SJC to 4 caps bid if RR\<20%). At 12w: ①-④ Same as moderate depression (including SSRI tapering if efficacy met and stable).
Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 12 weeks of treatment
Hamilton Depression Scale-17 (HAMD-17); minimum value: 0，maximum value: 52; higher scores mean a worse outcome.
Total effective rate based on Hamilton Depression Scale-17 (HAMD-17) score at 4, 8, 16, and 24 weeks of treatment
Hamilton Depression Scale-17 (HAMD-17); minimum value: 0, maximum value: 52; higher scores mean a worse outcome.
Remission rate, reduction rate, and change of Hamilton Depression Scale-17 (HAMD-17) score at 4, 8, 12, 16, and 24 weeks of treatment
Hamilton Depression Scale-17 (HAMD-17); minimum value: 0, maximum value: 52; higher scores mean a worse outcome.
Total effective rate, remission rate, reduction rate, and change of Hamilton Anxiety Scale (HAMA) score at 4, 8, 12, 16, and 24 weeks of treatment
Hamilton Anxiety Scale (HAMA); minimum value: 0, maximum value: 56; higher scores mean a worse outcome.
Change in Dimensional Anhedonia Rating Scale (DARS) score from baseline at 4, 8, 12, 16, and 24 weeks of treatment
Dimensional Anhedonia Rating Scale (DARS); minimum value: 0, maximum value: 68; higher scores mean a better outcome.
Click on the lead sponsor to view all of their trials.
Peking University
Lead sponsor
Peking University Sixth Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
