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).
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
106
Auricular vagus nerve stimulation is a typical representative of TCM modernization.
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.
Institute of Acupuncture and Moxibustion
Beijing, Beijing Municipality, China
RECRUITING17 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.
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
14 Item Hamilton Anxiety Scale (HAMA-14) Score Change
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.
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
NE(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week
5-HT(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week
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DA(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week
Cortisol(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week
ACTH(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week
GABA(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week
Glutamate(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week
BDNF(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week
bFGF(ng/L)
Biochemical indicators of peripheral blood
Time frame: Baseline and 8th week