Auricular Concha Electro-acupuncture for the Treatment of Depression

NCT03607331 | Unknown Early Phase 1

• 1 other identifier: ChinaACMS-5
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Depressive Symptom; Depressive Disorder

Keywords

depression; electro-acupuncture; auricular concha

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 14 Item Hamilton Anxiety Scale (HAMA-14) Score Change

  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)

  Baseline and 8th week

• 5-HT(ng/L)

  Baseline and 8th week

• DA(ng/L)

  Baseline and 8th week

• Cortisol(ng/L)

  Baseline and 8th week

Other Outcomes (4)

• systolic blood pressure (mmHg)

  Baseline and 8th week

• diastolic blood pressure (mmHg)

  Baseline and 8th week

• respiration rate(breaths/min)

  Baseline and 8th week

Study Arms (2)

Auricular vagus nerve stimulation

EXPERIMENTAL

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

Citalopram

ACTIVE COMPARATOR

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

Interventions

Auricular vagus nerve stimulation DEVICE

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

Also known as: vagus nerve stimulation at auricular concha

Auricular vagus nerve stimulation

Citalopram DRUG

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.

Also known as: brand name：Cipramil, SFDA J20130028

Citalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Item Hamilton Depression Rating Scale (HAMD-17) score \> 7, and \<24;
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Institute of Acupuncture and Moxibustion

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: July 31, 2018
• Study Start: September 17, 2018
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: April 22, 2019

Record last verified: 2019-04

Locations

CN (1)