Auricular Concha Electro-acupuncture for the Treatment of Depression

Early Phase 1

• Conditions: Depression; Depressive Symptom; Depressive Disorder
• Interventions: Device: Auricular vagus nerve stimulation; Drug: Citalopram

• Registration Number: NCT03607331
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-07-30
• Study First Posted: 2018-07-31
• Study Start: 2018-09-17
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-19
• Last Update Posted: 2019-04-22
• Primary Completion: 2019-07-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular vagus nerve stimulation	Auricular vagus nerve stimulation	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
Citalopram	Citalopram	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

Primary Outcome Measures

Name	Time	Method
17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change	Baseline and 1 week,baseline and 2th weeks,baseline and 4th weeks,baseline and 6th weeks,baseline and 8th weeks, baseline and 10th weeks after treatment, baseline and 12th weeks after treatment	The Hamilton Depression Rating Scale has proven useful for determining the level of depression before, during, and after treatment. It is based on the clinician's interview with the patient and probes symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss. The interview and scoring takes about 15 minutes. The rater enters a number for each symptom construct that ranges from 0 (not present) to 4 (extreme symptoms). The higher the total score is, the worse it is.The total score of 17HAMD more than 24 is defined as major depression, more than 17 but less than 24 is mild or moderate depression, and less than 7 is no depression.

Secondary Outcome Measures

Name	Time	Method
14 Item Hamilton Anxiety Scale (HAMA-14) Score Change	Baseline and 1 week,baseline and 2th weeks,baseline and 4th weeks,baseline and 6th weeks,baseline and 8th weeks, baseline and 10th weeks after treatment, baseline and 12th weeks after treatment	This widely-used interview scale measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. The higher the total score is, the worse it is. The total score of HAMA-14 more than 29 is defined as severe anxiety, more than 21 but less than 29 is obvious anxiety, more than 14 but less than 21 is certain anxiety, more than 7 but less than 14 is likely to be anxiety, and less than 6 is no anxiety.
NE(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood
5-HT(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood
DA(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood
Cortisol(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood
ACTH(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood
GABA(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood
Glutamate(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood
BDNF(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood
bFGF(ng/L)	Baseline and 8th week	Biochemical indicators of peripheral blood

Trial Locations

Locations (1)

Institute of Acupuncture and Moxibustion; 🇨🇳 Beijing, Beijing, China