Auricular Concha Electro-acupuncture for the Treatment of Depression

April 19, 2019 updated by: Peijing Rong, China Academy of Chinese Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Institute of Acupuncture and Moxibustion
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
14 Item Hamilton Anxiety Scale (HAMA-14) Score Change
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
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)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week
5-HT(ng/L)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week
DA(ng/L)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week
Cortisol(ng/L)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week
ACTH(ng/L)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week
GABA(ng/L)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week
Glutamate(ng/L)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week
BDNF(ng/L)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week
bFGF(ng/L)
Time Frame: Baseline and 8th week
Biochemical indicators of peripheral blood
Baseline and 8th week

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
systolic blood pressure (mmHg)
Time Frame: Baseline and 8th week
Physiological indicators
Baseline and 8th week
diastolic blood pressure (mmHg)
Time Frame: Baseline and 8th week
Physiological indicators
Baseline and 8th week
respiration rate(breaths/min)
Time Frame: Baseline and 8th week
Physiological indicators
Baseline and 8th week
pulse rate (beats/min)
Time Frame: Baseline and 8th week
Physiological indicators
Baseline and 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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