Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Auricular Concha Electro-acupuncture for the Treatment of Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03607331
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Peijing Rong, China Academy of Chinese Medical Sciences

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE July 31, 2018
Last Update Posted Date April 22, 2019
Actual Study Start Date  ICMJE September 17, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03607331 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2018)
  • 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.
  • NE(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
  • 5-HT(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
  • DA(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
  • Cortisol(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
  • ACTH(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
  • GABA(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
  • Glutamate(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
  • BDNF(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
  • bFGF(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 30, 2018)
  • systolic blood pressure (mmHg) [ Time Frame: Baseline and 8th week ]
    Physiological indicators
  • diastolic blood pressure (mmHg) [ Time Frame: Baseline and 8th week ]
    Physiological indicators
  • respiration rate(breaths/min) [ Time Frame: Baseline and 8th week ]
    Physiological indicators
  • pulse rate (beats/min) [ Time Frame: Baseline and 8th week ]
    Physiological indicators
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Auricular Concha Electro-acupuncture for the Treatment of Depression
Official Title  ICMJE Auricular Concha Electro-acupuncture for the Treatment of Mild to Moderate Depression: A Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Depressive Symptom
  • Depressive Disorder
Intervention  ICMJE
  • Device: Auricular vagus nerve stimulation
    Auricular vagus nerve stimulation is a typical representative of TCM modernization.
    Other Name: vagus nerve stimulation at auricular concha
  • 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 Name: brand name:Cipramil, SFDA J20130028
Study Arms  ICMJE
  • 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
    Intervention: Device: Auricular vagus nerve stimulation
  • 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
    Intervention: Drug: Citalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2018)
106
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03607331
Other Study ID Numbers  ICMJE ChinaACMS-5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peijing Rong, China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE China Academy of Chinese Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account China Academy of Chinese Medical Sciences
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP