Depressive State After ACS
Conditions
Interventions
Treatment Group:Shugan Jieyu Capsules
Control Group:Placebo of Shugan Jieyu Capsules
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old; 2. Diagnosed with ACS (Acute Coronary Syndrome) within 2-12 weeks post-diagnosis; the condition is stable; 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale - 17 items; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dimensional Anhedonia Rating Scale;Major Adverse Cardiovascular and Cerebrovascular Events;adrenocorticotropic hormone;Short Form-36 Health Survey;Corticotropin-Releasing Factor;Generalized Anxiety Disorder-7 (GAD-7);Seattle Angina Questionnaire, SAQ;Inflammatory Factors;Brain-Derived Neurotrophic Factor;Hamilton Anxiety Rating Scale (HAMA);Patient Health Questionnaire-9 (PHQ-9);Cardiopulmonary Exercise Testing;Cortisol;Montreal Cognitive Assessment; | — |
Countries
CHINA
Contacts
Public ContactRuina Bai
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed