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

ConditionsDepressive 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)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorJing Han

About this trial

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 .

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention
sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Control

Treatment groups

120 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Jing Han

Lead sponsor

Tang-Du Hospital

Sponsor institution

Source ClinicalTrials.gov