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Analysis of the efficacy and safety of SSRIs combined with Shugan Jieyu in the treatment of depression: a multicenter randomized, controlled, double-blind, prospective study

SSRIs combined with Shugan Jieyu in the treatment of depression: a multicenter randomized, controlled, double-blind, prospective study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041328
Enrollment
Unknown
Registered
2020-12-23
Start date
2020-12-22
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Outpatients or inpatients 18 years old <= age <= 65 years old, male or female; 2) A psychiatric clinician performs DSM-IV fixed-form clinical examination (SCID) to screen patients with depression, and meets the ICD-10 depressive episode diagnostic criteria; diagnosis by Chinese medicine; 3) Have sufficient audio-visual skills and comprehension skills, with an educational level above junior high school; 4) Subjects signed a written informed consent form and volunteered to participate in this clinical study.

Exclusion criteria

Exclusion criteria: 1) Existing serious and active physical diseases that may interfere with the research treatment (abnormal indicators> 2 times the normal value), or the current physical disease medication and the study drug have a pharmacological conflict; 2) Patients who meet the ICD-10 diagnostic criteria for other mental disorders (mental disorders such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, physical symptoms and related disorders); 3) Pregnant or lactating women, or planning to become pregnant; 4) Current serious suicide risk (eg HAMD-17 item 3 (suicide item) >= 3 points); 5) Received electroconvulsive therapy (MECT) in the past month; 6) According to the judgment of the investigator, there are other situations that are not suitable for participating in clinical trials.

Design outcomes

Primary

MeasureTime frame
The reduction rate of Hamilton depression scale after 6 weeks of treatment;

Countries

China

Contacts

Public ContactHu Lei

Shandong Mental Health Center

hulei616@163.com+86 15588877609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026