Auricular Concha Electro-acupuncture for the Treatment of Depression

Auricular Concha Electro-acupuncture for the Treatment of Mild to Moderate Depression: A Randomized Controlled Trial

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).

Study Overview

• Status: Unknown
• Conditions: Depressive Disorder; Depression; Depressive Symptom
• Intervention / Treatment: Drug: Citalopram; Device: Auricular vagus nerve stimulation

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 Type: Interventional
• Enrollment (Anticipated): 106
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Institute of Acupuncture and Moxibustion
      • Contact: Yufeng Zhao, PhD; Phone Number: 86 13651115411; Email: snowmanzhao@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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.; Other Names: brand name：Cipramil, SFDA J20130028
Experimental: 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	Device: Auricular vagus nerve stimulation; Auricular vagus nerve stimulation is a typical representative of TCM modernization.; Other Names: vagus nerve stimulation at auricular concha

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
14 Item Hamilton Anxiety Scale (HAMA-14) Score Change	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.	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
NE(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
5-HT(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
DA(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Cortisol(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
ACTH(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
GABA(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Glutamate(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
BDNF(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
bFGF(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure (mmHg)	Physiological indicators	Baseline and 8th week
diastolic blood pressure (mmHg)	Physiological indicators	Baseline and 8th week
respiration rate(breaths/min)	Physiological indicators	Baseline and 8th week
pulse rate (beats/min)	Physiological indicators	Baseline and 8th week

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: July 30, 2018
• First Posted (Actual): July 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2019
• Last Update Submitted That Met QC Criteria: April 19, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: depression; electro-acupuncture; auricular concha
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: ChinaACMS-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No