Depressive disorder
Conditions
Interventions
Intervention Group / Treatment Group:The experimental group will receive ta-VNS at auricular acupoints Heart (CO15) and Kidney (CO10) in the cymba conchae using Hwato Electronic Acupuncture Apparatus
No-Intervention Control / Standard Care Control:Patients will receive standard-dose oral antidepressants (SSRIs: sertraline, citalopram, paroxetine, or fluvoxamine
SNRIs: mirtazapine, venlafaxine, or duloxetine), one or two agents selected based on clinical presentation. Low-dose benzodiazepines may be added for severe sleep disturbances.
Sham Control Group / Sham Stimulation Group:Based on standard care, participants will receive sham auricular stimulation at the upper helix (midpoint of outer ear margin), a non-vagal innervation area
Sponsors
Hangzhou Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the aforementioned diagnostic criteria for depression and insomnia in both Traditional Chinese Medicine (TCM) and Western medicine, with a TCM syndrome differentiation of "Heart-Kidney Non-Interaction" (disharmony between the heart and the kidney); 2. Total score on the Pittsburgh Sleep Quality Index (PSQI) > 7; 3. HAMD-24 item score >= 8 points and < 35 points; 4. Age 18–65 years, gender not limited; 5. Educational level of junior high school or above; 6. Adheres to the ethical principles of the Declaration of Helsinki, voluntarily participates, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Organic mental disorders, or depression and insomnia caused by psychoactive substances and non-addictive substances; 2. Those with combined organic brain diseases; 3. Those with severe diseases of the cardiovascular and cerebrovascular system, liver, kidneys, hematopoietic system, etc.; 4. People with claustrophobia or other mental disorders (such as schizophrenia, bipolar disorder, etc.); 5. Those with severe impulsiveness, suicidal tendencies and a high risk of self-harm; 6. Those with poor cooperation and unable to lie still; 7. Those with metal implants in their bodies; 8. Pregnant and lactating women; 9. Those with severe skin damage on the ears; 10. Had participated in other researchers within 8 weeks prior to the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (24-HAMD) Score;Pittsburgh Sleep Quality Index (PSQI) Score;Brain Functional Activity Indices (ALFF, fALFF, ReHo, FC);Traditional Chinese Medicine Syndrome Score;fMRI Structural Imaging Data (Gray Matter Volume, Cortical Thickness, Sulcal Depth, Complexity); | — |
Countries
China
Contacts
Public ContactXu Zhe
Hangzhou Hospital of Traditional Chinese Medicine
Outcome results
None listed