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

Phase 4

Recruiting

• Conditions: Depression

• Registration Number: ITMCTR2100004545
• Lead Sponsor: Shandong Mental Health Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The reduction rate of Hamilton depression scale after 6 weeks of treatment;