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

NCT07785284 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-08-25

No results posted yet for this study

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.

Conditions

  • Outpatients or Inpatients With Depression

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).

Sponsors & Collaborators

  • Peking University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785284 on ClinicalTrials.gov