Clinical trial NCT03607331: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Depression
Depressive Symptom
Depressive Disorder
Keywords: depression
electro-acupuncture
auricular concha
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change
timeFrame: 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:
measure: 14 Item Hamilton Anxiety Scale (HAMA-14) Score Change
timeFrame: 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
measure: NE(ng/L)
timeFrame: Baseline and 8th week
measure: 5-HT(ng/L)
timeFrame: Baseline and 8th week
measure: DA(ng/L)
timeFrame: Baseline and 8th week
measure: Cortisol(ng/L)
timeFrame: Baseline and 8th week
measure: ACTH(ng/L)
timeFrame: Baseline and 8th week
measure: GABA(ng/L)
timeFrame: Baseline and 8th week
measure: Glutamate(ng/L)
timeFrame: Baseline and 8th week
measure: BDNF(ng/L)
timeFrame: Baseline and 8th week
measure: bFGF(ng/L)
timeFrame: Baseline and 8th week
Other outcomes:
measure: systolic blood pressure (mmHg)
timeFrame: Baseline and 8th week
measure: diastolic blood pressure (mmHg)
timeFrame: Baseline and 8th week
measure: respiration rate(breaths/min)
timeFrame: Baseline and 8th week
measure: pulse rate (beats/min)
timeFrame: Baseline and 8th week
Locations:
city: Beijing
country: China
facility: Institute of Acupuncture and Moxibustion
state: Beijing
Study officials:
References: