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NCT07454070
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
NA trial testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention in Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate) in 120 participants. Not yet recruiting.
10 September 2026
Quick facts
| Lead sponsor | Jing Han |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 8 March 2026 |
| Primary completion | 10 September 2026 |
| Estimated completion | 28 September 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention
- sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Control
Conditions studied
- Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate) — all drugs for Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate) →
- Acute Coronary Syndrome (ACS) — all drugs for Acute Coronary Syndrome (ACS) →
- Percutaneous Coronary Intervention (PCI) — all drugs for Percutaneous Coronary Intervention (PCI) →
- Depressive Disorder — all drugs for Depressive Disorder →
Sponsor
Jing Han
Who can join
18 and older, any sex, with Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate) or Acute Coronary Syndrome (ACS). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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 .
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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- PubMed search for NCT07454070
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07454070 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jing Han
- Last refreshed: 6 March 2026
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