Major Depressive Disorder(MDD)
Conditions
Interventions
Group A:taVNS + Escitalopram pills
Group B:taVNS + placebo pills
Group C:tnVNS+ Escitalopram pills
Group D:tnVNS+ placebo pills
Sponsors
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for depressive disorders, either first-episode or recurrent; (2) Be 18-65 years of age (both 18 and 65 years), regardless of gender; (3) Meeting mild (7 = 17-item Hamilton Depression Rating Scale score <14) and moderate (14 = 17-item Hamilton Depression Rating Scale score <20); (4) No risk of suicide, "No" on all items of the C-SSRS, and a score of <3 on item 3 (suicide) of the HAMD-17; (5) Not receiving any antidepressant treatment within the previous one month; (6) Voluntary participation in this study and my signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with current or prior psychiatric disorders consistent with other DSM-5 diagnoses, such as bipolar disorder, schizophrenia, post-traumatic stress disorder, and personality disorders; (2) Patients with severe or unstable cardiovascular, respiratory, hepatic, renal, hematologic, or other systemic disorders, as well as acute illnesses, infectious diseases, or malignancies, who are not considered by the investigator to be suitable for enrollment in this study; (3) Presence of alcohol (or drug) dependence or abuse and tobacco addiction (more than 10 sticks per day); (4) Pregnant or lactating women, or those planning to become pregnant, or those who do not consent to the use of contraception; (6) Those with external ear stumps, ulcers and skin allergies (7) Those who have participated in any other clinical study in the past 3 months (8) Those who, in the judgment of the investigator, are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the 17-item Hamilton Depression Scale (HAMD-17); | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate/remission rate;14-item Hamilton Anxiety Inventory(HAMA-14);Pittsburgh Sleep Quality Index Inventory(PSQI);Columbia Suicide Severity Scale (C-SSRS);Side Effects Rating Scale (SERS); | — |
Countries
China
Contacts
Public ContactRong Peijing
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Outcome results
None listed