chronic coronary syndrome
Conditions
Interventions
Sponsors
The Eighth Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-75 years; 2. Meets the diagnosis for chronic coronary syndrome; 3. HAMD-17 score between 7 and 24, with depressed mood or loss of interest symptoms lasting for more than 2 weeks; 4. Has never taken antidepressants, or if previously taken, has stopped for more than six months; 5. Has normal communication and literacy skills; 6. Fully understands the trial process, agrees to participate in the clinical trial, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with acute coronary syndrome within the past year; 2.Patients with a Hamilton Depression Rating Scale-17 score 24; 3.Patients with severe anxiety or diagnosed with other mental disorders (e.g., schizophrenia spectrum, severe personality disorders, bipolar affective disorders, etc.) other than depression; 4.Patients with severe mental health disorders and severe suicidal tendencies (.Hamilton Depression Rating Scale-17 Item 3 suicide ideation score >=3), as their condition may significantly impact the accuracy of the study and patient safety; 5.Patients with liver or kidney dysfunction (Alanine Aminotransferase or Aspartate Aminotransferase >1.5 times Upper Limit of Normal, Creatinine, Blood Urea Nitrogen >Upper Limit of Normal); 6.Patients who have undergone major surgeries (e.g., cardiac surgery, neurosurgery) or have a history of significant trauma within the past year; 7.Patients who have undergone percutaneous coronary intervention within the past 3 months; 8.Patients with malignant tumors or a life expectancy <1 year; 9.Patients who have participated in or are currently participating in other clinical studies within the past 3 months; 10.Patients lacking the ability to independently complete assessment scales or currently receiving other treatments or antidepressant medications; 11.Participants with known intolerance or allergies to the components of the investigational drug used in this study. Note: Any participant meeting any of the above criteria will be considered ineligible for this clinical study and will be promptly excluded from the study population.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Hamilton Depression Rating Scale-17 Depression Scale from baseline to week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| The MOS 36-item short-form health survey;Hamilton Depression Rating Scale-17 Depression Scale, 7-Factor;vital sign;urinalysis;renal function;Generalized Anxiety Disorder-7 generalized anxiety self-rating scale;hepatic function;Seattle angina questionnaire and its dimensions score;chinese medicine syndrome scores;The hypothalamic-pituitary-adrenal axis;Cure rate of Hamilton Depression Rating Scale-17 depression scale;12-lead electrocardiogram;blood routine;Hypersensitive C-reactive protein; | — |
Countries
China
Contacts
Public ContactXu Danping
The Eighth Affiliated Hospital Sun Yat-sen University
Outcome results
None listed