Auricular Concha Electro-acupuncture for the Treatment of Mild to Moderate Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- 17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •17 Item Hamilton Depression Rating Scale (HAMD-17) score > 7, and <24;
- •Signed informed consent.
排除标准
- •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.
研究组 & 干预措施
Auricular vagus nerve stimulation
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
干预措施: Auricular vagus nerve stimulation (Device)
Citalopram
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
干预措施: Citalopram (Drug)
结局指标
主要结局
17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change
时间窗: 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.
次要结局
- 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)
- ACTH(ng/L)(Baseline and 8th week)
- GABA(ng/L)(Baseline and 8th week)
- Glutamate(ng/L)(Baseline and 8th week)
- BDNF(ng/L)(Baseline and 8th week)
- bFGF(ng/L)(Baseline and 8th week)
研究者
Peijing Rong
The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences