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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

ClinicalTrials.gov IDNCT07454070

PhaseNA

Enrollment120

SponsorJing Han

Age18 Years

SexALL

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Conditions studied

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)

About this 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 .

Interventions

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention — Transcutaneous auricular vagus nerve stimulation (taVNS) is delivered to the cymba conchae of the ear using a dedicated stimulator device, with parameters set as 20 Hz frequency, 0.5-3mA intensity, 20 minutes per session, twice daily for 8 weeks.
Device: sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Control — sham Transcutaneous Auricular Vagus Nerve Stimulation Control treatment with the same device of active stimulation group, wearing method, and parameter adjustments as active stimulation group However, stimulation will only be delivered for the first 5 seconds, with no subsequent electrical output. Treatment frequency will be identical to that of active stimulation group.

Primary outcomes

Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HAMD-17) from baseline (Week 0) to Week 8 (from baseline (Week 0) to Week 8)

Eligibility information

Inclusion Criteria: * Age ≥18 years * Meeting the diagnostic criteria for ACS * 14 days to 12 months after successful PCI, with stable vital signs * Meeting the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) * HAMD-17 score ≥7 and \<24 (mild-to-moderate depression), with HAMA score \<HAMD score; * Refusal of psychiatric consultation, antidepressant medication, or psychological therapy by the patient or their legal representative after full informed consent * Voluntary participation in the study and signing of the informed consent form Exclusion Criteria: * Severe heart failure (New York Heart Association \[NYHA\] class ≥III) * Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg) * Electrocardiographic abnormalities (first-degree atrioventricular block with PR interval ≥0.20 s, second-degree type II or third-degree atrioventricular block at any time, 24-hour average heart rate ≤50 beats per minute, RR interval ≥3 s) or a history of syncope unrelated to the current ACS * Dialysis-dependent patients * Previous renal sympathetic denervation or vagal ganglion ablation * Expected survival time \<4 months * Pre-PCI diagnosis of severe mental illnesses, including schizophrenia, severe intellectual disability, or substance abuse * Current use of antipsychotic medications * High suicide risk * Pregnant or lactating women * Left ear diseases, acute exacerbation of asthma or chronic obstructive pulmonary disease, or other conditions precluding taVNS treatment * Implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implantable stimulators (e.g., vagus nerve stimulator, deep brain stimulator)

Study locations

Tang-Du Hospital,Department of Cardiology, Xi'an, Shaanxi 710038 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.