Auricular Concha Electro-acupuncture for the Treatment of Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03607331
• Other study ID #: ChinaACMS-5
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 17, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: April 2019
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: August 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ? and ? above cardiac function) , obvious abnormalities of liver and kidney function (Biomarkers more than 3 times normal);

7. Serious suicidal ideation or suicidal behavior.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Symptom

Intervention

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

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.

Locations

Country	Name	City	State
China	Institute of Acupuncture and Moxibustion	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	systolic blood pressure (mmHg)	Physiological indicators	Baseline and 8th week
Other	diastolic blood pressure (mmHg)	Physiological indicators	Baseline and 8th week
Other	respiration rate(breaths/min)	Physiological indicators	Baseline and 8th week
Other	pulse rate (beats/min)	Physiological indicators	Baseline and 8th week
Primary	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	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
Secondary	NE(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Secondary	5-HT(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Secondary	DA(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Secondary	Cortisol(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Secondary	ACTH(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Secondary	GABA(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Secondary	Glutamate(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Secondary	BDNF(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week
Secondary	bFGF(ng/L)	Biochemical indicators of peripheral blood	Baseline and 8th week