Depression, Depressive Disorder, Depressive Symptom
Conditions
Keywords
depression, electro-acupuncture, auricular concha
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.
Interventions
Auricular vagus nerve stimulation is a typical representative of TCM modernization.
DRUGCitalopram
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.
Sponsors
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 17 Item Hamilton Depression Rating Scale (HAMD-17) 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| DA(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
| GABA(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
| Glutamate(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
| BDNF(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
| bFGF(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
| 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 | 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. |
| NE(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
| 5-HT(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
| Cortisol(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
| ACTH(ng/L) | Baseline and 8th week | Biochemical indicators of peripheral blood |
Other
| Measure | Time frame | Description |
|---|---|---|
| respiration rate(breaths/min) | Baseline and 8th week | Physiological indicators |
| pulse rate (beats/min) | Baseline and 8th week | Physiological indicators |
| diastolic blood pressure (mmHg) | Baseline and 8th week | Physiological indicators |
| systolic blood pressure (mmHg) | Baseline and 8th week | Physiological indicators |
Countries
China
Outcome results
None listed