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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Citalopram | Active Comparator | citalopram for oral administration; 10mg for the first 1-3 days, 20mg for the following 4-7 daysļ¼40mg for the left days within two months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular vagus nerve stimulation | Device | Auricular vagus nerve stimulation is a typical representative of TCM modernization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| systolic blood pressure (mmHg) | Physiological indicators | Baseline and 8th week |
| diastolic blood pressure (mmHg) | Physiological indicators | Baseline and 8th week |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Acupuncture and Moxibustion | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| 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. |
|
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| 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 | Baseline and 8th week |
| 5-HT(ng/L) | Biochemical indicators of peripheral blood | Baseline and 8th week |
| DA(ng/L) | Biochemical indicators of peripheral blood | Baseline and 8th week |
| Cortisol(ng/L) | Biochemical indicators of peripheral blood | Baseline and 8th week |
| ACTH(ng/L) | Biochemical indicators of peripheral blood | Baseline and 8th week |
| GABA(ng/L) | Biochemical indicators of peripheral blood | Baseline and 8th week |
| Glutamate(ng/L) | Biochemical indicators of peripheral blood | Baseline and 8th week |
| BDNF(ng/L) | Biochemical indicators of peripheral blood | Baseline and 8th week |
| bFGF(ng/L) | Biochemical indicators of peripheral blood | Baseline and 8th week |
| respiration rate(breaths/min) | Physiological indicators | Baseline and 8th week |
| pulse rate (beats/min) | Physiological indicators | Baseline and 8th week |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |