Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Shugan Jieyu Capsules in Intervention for Depression Status Post Acute Coronary Syndrome (ACS)

Phase 4

• Conditions: Depressive State After ACS

• Registration Number: ITMCTR2024000099
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Age range: 18-75 years old;
2. Diagnosed with ACS (Acute Coronary Syndrome) within 2-12 weeks post-diagnosis;
3. Score on the HAMD-17 (Hamilton Depression Rating Scale) is between 17 and 24, inclusive, and symptoms of depressive mood or decreased interest have been present continuously for more than 2 weeks;
4. The participant has provided informed consent, voluntarily participates in this study, and has signed the informed consent form personally.
Note:
1) Depressive mood: Experiencing feelings of depression almost every day and for most of the day, either subjectively reported (e.g., feeling sad, empty, hopeless) or observed by others (e.g., showing signs of crying).
2) Decreased interest: Almost every day and for most of the day, there is a significant reduction in interest or pleasure in all or nearly all activities (either self-reported or observed).

Exclusion Criteria

1. Impaired liver or kidney function (ALT or AST levels above 1.5 times the ULN, Cr or BUN levels above the ULN);
2. Participants with severe hematological disorders, malignant tumors, or other major illnesses;
3. Participants with severe suicidal tendencies (suicidal tendency score =3 on item 3 of the HAMD-17);
4. Participants with a history of depression or severe psychiatric illness prior to ACS onset;
5. Participants with heart failure classified as NYHA III-IV, EF <35%, or requiring ongoing mechanical assist therapy;
6. Participants who have taken antidepressants for a long time or within the past 4 weeks;
7. Participants who have taken medications containing Acanthopanax or St. John's wort for a long time or within the past 4 weeks;
8. Pregnant or breastfeeding women, or those planning to become pregnant during the trial period;
9. Participants who have participated in or are currently participating in another clinical study within the last three months;
10. Patients with other autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel disease, etc.;
11. Patients who have had acute infections within the past 4 weeks, or show symptoms and signs such as fever, cough, shortness of breath, abnormal white blood cell counts;
12. Patients who have taken immunosuppressive drugs within the last three months;
13. Patients who are suspected or confirmed to be allergic to the investigational drug;
14. Patients with conditions unsuitable for cardiopulmonary exercise testing, such as acute rapid arrhythmias, pulmonary edema, severe aortic valve stenosis, severe anemia, etc.

Study & Design

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