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

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).

Condition or disease Intervention/treatment Phase
Depression Depressive Symptom Depressive Disorder Device: Auricular vagus nerve stimulation Drug: Citalopram Early Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Auricular Concha Electro-acupuncture for the Treatment of Mild to Moderate Depression: A Randomized Controlled Trial
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
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 Name: vagus nerve stimulation at auricular concha

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 Name: brand name:Cipramil, SFDA J20130028




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. NE(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood

  3. 5-HT(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood

  4. DA(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood

  5. Cortisol(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood

  6. ACTH(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood

  7. GABA(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood

  8. Glutamate(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood

  9. BDNF(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood

  10. bFGF(ng/L) [ Time Frame: Baseline and 8th week ]
    Biochemical indicators of peripheral blood


Other Outcome Measures:
  1. systolic blood pressure (mmHg) [ Time Frame: Baseline and 8th week ]
    Physiological indicators

  2. diastolic blood pressure (mmHg) [ Time Frame: Baseline and 8th week ]
    Physiological indicators

  3. respiration rate(breaths/min) [ Time Frame: Baseline and 8th week ]
    Physiological indicators

  4. pulse rate (beats/min) [ Time Frame: Baseline and 8th week ]
    Physiological indicators



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607331


Locations
Layout table for location information
China, Beijing
Institute of Acupuncture and Moxibustion Recruiting
Beijing, Beijing, China
Contact: Yufeng Zhao, PhD    86 13651115411    snowmanzhao@163.com   
Sponsors and Collaborators
China Academy of Chinese Medical Sciences

Layout table for additonal information
Responsible Party: Peijing Rong, The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03607331     History of Changes
Other Study ID Numbers: ChinaACMS-5
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peijing Rong, China Academy of Chinese Medical Sciences:
depression
electro-acupuncture
auricular concha
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Mood Disorders
Mental Disorders
Dexetimide
Citalopram
Behavioral Symptoms
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents