Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT06975592
Eligibility Criteria:
Inclusion Criteria:
1. Healthy control group 1) Good health and no gastrointestinal diseases; 2) No previous history of mental illness; 3) No previous history of cardiovascular disease;
2. Depression group
1\) Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists; 2) Patients with first-episode depression; 3) Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks.
3\. Depression with cardiovascular disease group
1. Meet the diagnostic criteria of the latest guidelines for depression, and be clinically diagnosed by at least two psychiatrists;
2. Patients with first-episode depression;
3. Have not taken any psychoactive drugs before or have not taken any psychoactive drugs within 4 weeks.
4. There is definite clinical evidence of heart failure, coronary heart disease, hypertension or arrhythmia.
Exclusion Criteria:
1. Have a history of alcohol dependence, organic brain diseases, nervous system diseases and other complex mental diseases;
2. Long-term use of psychoactive drugs/use of psychoactive drugs within 4 weeks;
3. Patients with thyroid dysfunction
4. Patients with severe liver and kidney dysfunction;
5. Patients with chronic obstructive pulmonary disease, interstitial pulmonary fibrosis and pulmonary hypertension;
6. Patients with autoimmune diseases and tumors;
7. used antibiotics, yogurt or other drugs or foods that affect intestinal flora within 4 weeks;
8. Pregnant or lactating women;
9. There is a serious impairment of cognitive function, which makes it impossible to cooperate with the research procedure;
10. Have received invasive medical procedures such as gastroscopy and colonoscopy in the past three months;
11. The diet has changed greatly in the past week;
12. Participate in simultaneous clinical trials;
13. Refuse to sign the informed consent for participating in the experiment.
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
85 Years
Study:
NCT06975592
Study Brief:
Protocol Section:
NCT06975592