Auricular Concha Electro-acupuncture for the Treatment of Depression

NCT ID: NCT03607331

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2019-08-01

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.

Conditions

Depression; Depressive Symptom; Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Auricular vagus nerve stimulation

Intervention Type: DEVICE

Auricular vagus nerve stimulation is a typical representative of TCM modernization.

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

Group Type: ACTIVE_COMPARATOR

Citalopram

Intervention Type: DRUG

Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.

Interventions

Auricular vagus nerve stimulation

Auricular vagus nerve stimulation is a typical representative of TCM modernization.

Intervention Type: DEVICE

Citalopram

Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.

Intervention Type: DRUG

Other Intervention Names

vagus nerve stimulation at auricular concha; brand name：Cipramil, SFDA J20130028

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Peijing Rong

The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Acupuncture and Moxibustion

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yufeng Zhao, PhD

Role: primary

snowmanzhao@163.com

86 13651115411

Other Identifiers

ChinaACMS-5

Identifier Type: -

Identifier Source: org_study_id