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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

ConditionsDepressive Disorder (Per DSM-V Criteria, Mild-to-moderate)Acute Coronary Syndrome (ACS)Percutaneous Coronary Intervention (PCI)Depressive DisorderPostoperative Psychological DistressHeart Rate Variability (HRV)Inflammatory FactorsRandomized 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention

    Device

    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.

  • sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Control

    Device

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Transcutaneous Auricular Vagus Nerve Stimulation Intervention (taVNS)Experimental treatment 1 intervention
Group B: Sham Transcutaneous Auricular Vagus Nerve Stimulation Control(sham taVNS)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

The primary outcome is the change in total HAMD-17 scores from baseline (Week 0, prior to the initiation of transcutaneous auricular vagus nerve stimulation \[taVNS\] intervention) to the end of the 8-week taVNS intervention (Week 8). HAMD-17 scores range from 0 to 52, with higher scores indicating more severe depressive symptoms; a negative change score reflects a reduction in depressive symptom severity and clinical improvement. All assessments are conducted by trained clinicians who are masked to the participants' study group allocation (active taVNS vs. sham taVNS).

Time frame
from baseline (Week 0) to Week 8

Secondary outcomes

1

Change in 17-item Hamilton Depression Rating Scale (HAMD-17) scores at multiple time points from baseline (Week 0) to Week 16

This outcome assesses the dynamic change in total HAMD-17 scores at baseline (Week 0), Week 4, Week 8 (end of intervention), and Week 16 (8-week follow-up post-intervention). HAMD-17 scores range from 0 to 52, with higher scores indicating more severe depressive symptoms; score reductions reflect sustained improvement in depressive symptoms post-intervention. Assessments are performed by blinded trained clinicians.

Time frame
From baseline to week 16 (every 4 weeks)
2

Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline (Week 0) to Week 16

Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline (Week 0) to Week 16

Time frame
From baseline to week 16 (every 4 weeks)
3

Change in Generalized Anxiety Disorder 7-item (GAD-7) scale scores from baseline (Week 0) to Week 16

This outcome evaluates the change in total GAD-7 scores at baseline (Week 0), Week 4, Week 8, and Week 16. GAD-7 is a self-reported scale with scores ranging from 0 to 21, where higher scores indicate more severe generalized anxiety symptoms; score changes reflect participants' self-perceived anxiety improvement.

Time frame
From baseline to week 16 (every 4 weeks)
4

Change in Beck Depression Inventory (BDI) scores from baseline (Week 0) to Week 16

This outcome assesses the change in total BDI scores at baseline (Week 0), Week 4, Week 8, and Week 16. BDI is a self-reported depression scale with scores ranging from 0 to 63, with higher scores indicating more severe self-reported depressive symptoms; score reductions reflect participants' subjective improvement in depressive symptoms.

Time frame
From baseline to week 16 (every 4 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jing Han

Lead sponsor

Tang-Du Hospital

Sponsor institution

Source ClinicalTrials.gov
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