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Clinical Evaluation of Stepwise Auricular Vagus Nerve Stimulation in Traditional Chinese Medicine for Subthreshold Depression in Adolescents and the Coupling Mechanism of Central Interoception with Peripheral Homeostasis

Clinical Evaluation of Stepwise Auricular Vagus Nerve Stimulation in Traditional Chinese Medicine for Subthreshold Depression in Adolescents and the Coupling Mechanism of Central Interoception with Peripheral Homeostasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001587
Enrollment
Unknown
Registered
2026-06-23
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

subthreshold depression

Interventions

Ear Acupoint Seed Pressing Group:Ear Acupoint Seed Pressing Therapy
Waitlist Control group:wait and see
Subcutaneous Needle Group:Subcutaneous needle therapy
Transcutaneous Auricular Vagus Nerve Electrostimulation Treatment Group:Transcutaneous Auricular Vagus Nerve Electrotherapy

Sponsors

Shenzhen City Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 24 Years

Inclusion criteria

Inclusion criteria: 1: Reports of depression, meeting the diagnostic criteria for StD in Western medicine and the diagnostic criteria for depression in traditional Chinese medicine (Yuping); 2: Age between 10-24 years, first episode, no prior use of antidepressants, gender (unrestricted); 3: Hamilton Depression Rating Scale (HAMD-17) score =7 and 14; Young Mania Rating Scale <8 and HCL-32 screening negative; 4: No use of any psychoactive medications or medications affecting cognitive function in the 2 weeks prior to treatment; 5: Educational level of primary school or above; 6: All subjects are right-handed with no clinical contraindications for scanning; 7: Participants voluntarily join and obtain handwritten informed consent from a valid legal guardian.

Exclusion criteria

Exclusion criteria: 1: Clinically diagnosed depressive episodes, or a history of any mental disorder or substance use, or known alcoholism or substance dependence; 2: Severe aphasia, physical disabilities, or any other factors that may affect neuropsychological assessments; or severe somatic diseases or obvious physical examination abnormalities (e.g., electrocardiogram); 3: Suicidal ideation within one month prior to enrollment, regardless of the presence of a specific plan, or patients assessed by the investigator to have a significant risk of suicide; 4: Antidepressant treatment or other therapies or medications within one week prior to the start of the trial; 5: Currently participating in other clinical trials; 6: Surgical scars, skin infections, or cranial defects at the auricular acupoint stimulation sites that may affect treatment; 7: Patients who have experienced vagus nerve stimulation needle fainting or are allergic to ear acupoint pressure bean plaster; 8: Refusal to sign the informed consent form, or inability to cooperate with neuropsychological assessments; 9: Patients with metal implants or claustrophobia, or other contraindications for MRI examinations.

Design outcomes

Primary

MeasureTime frame
Efficient;

Secondary

MeasureTime frame
12-month MDD conversion rate;Clinical Global Impressions Scale;T1 Response Rate;Step Therapy Remission Rate;

Countries

China

Contacts

Public ContactQin Xiude

Shenzhen City Traditional Chinese Medicine Hospital

qinxiude@foxmail.com13530967138

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026