Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 主要终点
- Montgomery-Asberg Depression Rating Scale Change
研究概览
简要总结
Experimental and clinical studies have indicated that acupuncture has a good effect for depression and comorbid pain. The purpose of this research is to compare the effect of comprehensive electro-acupuncture therapy and western medicine citalopram for for depressive disorder with comorbid psychogenic pain. This research is a assessor blinded, randomized controlled trials. 60 patients will be randomly divided into comprehensive electro-acupuncture group and western medicine citalopram for 8 weeks treatment and the therapeutic effect is done at the end of 1,2,4,6,8 week.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Conform with the diagnostic criteria of depression according to DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS (DSM-5TM)
- •Age from 18 to 50 year-old
- •Patients with the first onset depression
- •Patients with mild-to-moderate depression scored 12-30 by Montgomery scale
- •Patients with one psychogenic pain at least, and the degree of VAS is 3 or more
- •Volunteer participants willing to cooperate and obeying the treatment
排除标准
- •Pregnant woman
- •Patients with severe primary diseases and acute diseases of heart, brain, liver, kidney and hematopoietic systems and infectious disease, malignant tumor
- •Patients who can't stop taking drugs according to the requirement in the treatment period
- •Patients with a history of schizophrenia and other mental disorders
- •Patients with cognitive impairment or personality disorders
- •Patients have serious suicide idea or suicidal behavior
研究组 & 干预措施
ta-VNS & Electro-acupuncture
- Device:ta-VNS(transcutaneous vagus nerve stimulation):2 times per day,5 consecutive days per week for two months
- Other:Electro-acupuncture:3 times per week, once every other day for two months
干预措施: ta-VNS (Device)
ta-VNS & Electro-acupuncture
- Device:ta-VNS(transcutaneous vagus nerve stimulation):2 times per day,5 consecutive days per week for two months
- Other:Electro-acupuncture:3 times per week, once every other day for two months
干预措施: Electro-acupuncture (Other)
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
Montgomery-Asberg Depression Rating Scale Change
时间窗: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
Measure the severity of depressive episodes in patients with mood disorders, It contents ten items, and each item is scored 0-6.(0=no depression,6=depression as bad as can be), yielding a total between 0 and 60.
次要结局
- SF-McGill Pain Questionnaire(Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks)
- SF-36 Health Survey Questionnaire(Baseline and 4 weeks, baseline and 8 weeks)
- Pittsburgh Sleep Quality Index(Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks)
- Hamilton Anxiety Rating Scale(HAMA)(Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks)
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