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NOT YET RECRUITING
NCT07785284
NA

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

Sponsor: Peking University

View on ClinicalTrials.gov

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.

Official title: A Multicenter Real-World Study of Shugan Jieyu Capsules in the Treatment of Depression

Key Details

Gender

All

Age Range

13 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-08

Completion Date

2027-12

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

Shugan Jieyu Capsules

Mild 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).

Locations (1)

Institute of Mental Health, Peking University Sixth Hospital

Beijing, China