Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation on Alleviating Major Depressive Disorder in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention:A Prospective, Double-Blind,Randomized Controlled Study

This is a randomized, controlled study. ACS follow- up patients aged 18 to 80 years old with hemodynamic stability, who are 14 days to 1 year after PCI, are screened through the HAMD score and the HAMA score. Patients with a HAMD score greater than 7 points and a HAMD score higher than that of the HAMA, are included in this study. Patients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 20 minutes each time, twice a day with an 8-week treatment and a 8-week follow-up. All treatments were self-administered by the patients at home after they received training from the hospitals. The primary observation endpoints include the depression scores of the HAMD. The secondary observation endpoints include the HAMA 、GAD、 response and remission rates of HAMD ，as well as the PCL-C for post-traumatic stress disorder. We also observed the cardiac function indexes measured by echocardiography and the B-type natriuretic peptide .

NCT Number	NCT07454070
Lead Sponsor	Jing Han
Conditions	Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), Depressive Disorder, Postoperative Psychological Distress, Heart Rate Variability (HRV), Inflammatory Factors, Randomized Controlled Trial (RCT)
Enrollment	120 participants
Start Date	2026-01-06
Primary Completion	2026-06-08 (estimated)
Study Completion	2026-08-10 (estimated)
Updated on ClinicalTrials.gov	2026-06-16