Auricular Concha Electro-acupuncture for the Treatment of Depression

China Academy of Chinese Medical Sciences

Status and phase: Unknown; Early Phase 1

Conditions: Depressive Symptom; Depression; Depressive Disorder

Treatments: Drug: Citalopram; Device: Auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03607331

ChinaACMS-5

Details and patient eligibility

About

The objective of this study was to compare the therapeutic effects of Auricular Concha Electro-acupuncture and Citalopram on patients with major depressive disorder (MDD).

Full description

In this study, 106 patients with MDD were randomly divided into the auricular concha electro-acupuncture group and the citalopram group by the evaluation blind method and randomized control design, and were treated for 8 weeks and 4 weeks follow-up. In No. 0, 2, 4, 6, 8, 10, 12 Weekend, Hamilton Rating Scale for Depression-17 Item (HAM-D17) and Hamilton Anxiety Rating Scale (Ham-A) were performed for all patients. During the No. 0/8 weekend, patients were tested and analyzed for peripheral blood NE, 5-HT, DA, Cortisol, ACTH, GABA, glutamic acid, BDNF and BFGF, and the brain is also examined and analyzed by fMRI.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The diagnosis is consistent with DSM-V diagnostic criteria for mild-to- moderate depression;
2. Patients with the first onset or recurrence of the disease have not been treated with antidepressant or without antidepressant treatment before treatment for 3 months;
3. Age from 18 to 65 years old, with no gender;
4. Outpatient;
5. 17 Item Hamilton Depression Rating Scale (HAMD-17) score > 7, and <24;
6. Signed informed consent.

Exclusion criteria

1. In addition to depression, it conforms to the diagnostic criteria of any psychiatric disease;
2. Patients with a history of schizophrenia or other mental illness;
3. Patients with cognitive impairment or personality disorder;
4. In the past 6 months, patients who have met the DSM-V criteria for substance related and addictive disorders;
5. Before entering the group, any other antidepressant treatment is being accepted;
6. Patients with serious body disease, such as heart disease (namely Ⅱ and Ⅱ above cardiac function) , obvious abnormalities of liver and kidney function (Biomarkers more than 3 times normal);
7. Serious suicidal ideation or suicidal behavior.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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106 participants in 2 patient groups

Auricular vagus nerve stimulation

Experimental group

Description:

Auricular Concha Electro-acupuncture: twice a day at home as required, once in the morning and once in the evening, with 5 consecutive days per week for two months

Treatment:

Device: Auricular vagus nerve stimulation

Citalopram

Active Comparator group

Description:

citalopram for oral administration; 10mg for the first 1-3 days, 20mg for the following 4-7 days；40mg for the left days within two months

Treatment:

Drug: Citalopram