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Auricular Concha Electro-acupuncture for the Treatment of Depression

Primary Purpose

Depression, Depressive Symptom, Depressive Disorder

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Auricular vagus nerve stimulation
Citalopram
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, electro-acupuncture, auricular concha

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Acupuncture and MoxibustionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Auricular vagus nerve stimulation

Citalopram

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
NE(ng/L)
Biochemical indicators of peripheral blood
5-HT(ng/L)
Biochemical indicators of peripheral blood
DA(ng/L)
Biochemical indicators of peripheral blood
Cortisol(ng/L)
Biochemical indicators of peripheral blood
ACTH(ng/L)
Biochemical indicators of peripheral blood
GABA(ng/L)
Biochemical indicators of peripheral blood
Glutamate(ng/L)
Biochemical indicators of peripheral blood
BDNF(ng/L)
Biochemical indicators of peripheral blood
bFGF(ng/L)
Biochemical indicators of peripheral blood

Full Information

First Posted
May 15, 2018
Last Updated
April 19, 2019
Sponsor
China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03607331
Brief Title
Auricular Concha Electro-acupuncture for the Treatment of Depression
Official Title
Auricular Concha Electro-acupuncture for the Treatment of Mild to Moderate Depression: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Symptom, Depressive Disorder
Keywords
depression, electro-acupuncture, auricular concha

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auricular vagus nerve stimulation
Arm Type
Experimental
Arm 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
Arm Title
Citalopram
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Auricular vagus nerve stimulation
Other Intervention Name(s)
vagus nerve stimulation at auricular concha
Intervention Description
Auricular vagus nerve stimulation is a typical representative of TCM modernization.
Intervention Type
Drug
Intervention Name(s)
Citalopram
Other Intervention Name(s)
brand name：Cipramil, SFDA J20130028
Intervention Description
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.
Primary Outcome Measure Information:
Title
17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change
Description
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.
Time Frame
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 Measure Information:
Title
14 Item Hamilton Anxiety Scale (HAMA-14) Score Change
Description
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.
Time Frame
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
Title
NE(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Title
5-HT(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Title
DA(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Title
Cortisol(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Title
ACTH(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Title
GABA(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Title
Glutamate(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Title
BDNF(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Title
bFGF(ng/L)
Description
Biochemical indicators of peripheral blood
Time Frame
Baseline and 8th week
Other Pre-specified Outcome Measures:
Title
systolic blood pressure (mmHg)
Description
Physiological indicators
Time Frame
Baseline and 8th week
Title
diastolic blood pressure (mmHg)
Description
Physiological indicators
Time Frame
Baseline and 8th week
Title
respiration rate(breaths/min)
Description
Physiological indicators
Time Frame
Baseline and 8th week
Title
pulse rate (beats/min)
Description
Physiological indicators
Time Frame
Baseline and 8th week

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The diagnosis is consistent with DSM-V diagnostic criteria for mild-to- moderate depression; 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; Age from 18 to 65 years old, with no gender; Outpatient; 17 Item Hamilton Depression Rating Scale (HAMD-17) score > 7, and <24; Signed informed consent. Exclusion Criteria: In addition to depression, it conforms to the diagnostic criteria of any psychiatric disease; Patients with a history of schizophrenia or other mental illness; Patients with cognitive impairment or personality disorder; In the past 6 months, patients who have met the DSM-V criteria for substance related and addictive disorders; Before entering the group, any other antidepressant treatment is being accepted; 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); Serious suicidal ideation or suicidal behavior.
Facility Information:
Facility Name
Institute of Acupuncture and Moxibustion
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufeng Zhao, PhD
Phone
86 13651115411
Email
snowmanzhao@163.com

12. IPD Sharing Statement

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Auricular Concha Electro-acupuncture for the Treatment of Depression

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