Effects of Electroacupuncture With Different Frequencies for Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in anxiety and depression severity measure by Self-rating depression scale（SDS）
研究概览
简要总结
Two groups of subjects will be included 55 subjects in electroacupuncture with 2Hz group, 55 subjects in the electroacupuncture with 100Hz group. The clinical efficacy of electroacupuncture with different frequencies (2 Hz, 100 Hz) in the treatment of MDD will be observed by evaluation indicators, such as Self-rating depression scale and Hamilton depression scale.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from MDD in accordance with the diagnostic criteria;
- •Hamilton Depression Scale score is between 21 and 35 (mild to moderate MDD);
- •18≤age≤60 years, both gender;
- •Patients who have not used antidepressants and other psychiatric drugs (including traditional Chinese medicine), or have used them but have stopped for at least 2 weeks;
- •Patients have clear consciousness and could communicate with others normally;
- •Patients could understand the full study protocol and written informed consent is provided by themselves. Note: Subjects who meet the above six items will be included.
排除标准
- •Patients with bipolar disorder;
- •Patients with schizophrenia or other mental disorders;
- •Patients with severe medical diseases, tumors or diseases of the central nervous system;
- •Patients suffering from severe depressive episode with psychotic symptoms;
- •Suicidal patients;
- •Patients with seasonal depression;
- •Patients with organic depression;
- •Patients with alcohol or drug addicts;
- •Patients using other therapies;
- •Patients in pregnancy or lactation;
- •Patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment;
- •Patients with pacemakers;
- •Patients who are not suitable for electroacupuncture.
结局指标
主要结局
Change in anxiety and depression severity measure by Self-rating depression scale（SDS）
时间窗: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
This scale contains 20 items that reflect the subjective feelings of depression, 10 of which are positive scores and 10 are reverse scores. Each item is divided into four grades according to the frequency of symptoms, If it is a positive scoring question, it will be rated as 1, 2, 3, and 4 points; for a reverse scoring question, it will be rated as 4, 3, 2, and 1. After the evaluation, add up the scores in the 20 items to get the total rough score, and then multiply the rough score by 1.25 and take the integer part to get the standard score
Change in the severity of depression measure by Hamilton depression scale (HAMD)
时间窗: There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.
This scale is performed by two trained raters to perform a HAMD, usually in the form of conversation and observation. After the examination, the two raters will score independently
次要结局
- Change in sleep quality measured by Insomnia severity index (ISI)(There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.)
- Change in Traditional Chinese medicine syndrome score(There will be evaluated before intervention, at 2, 4weeks after intervention and at the end of 4-weeks follow-up.)
研究者
Xiaoyu Li
Attending Doctor
Zhejiang Chinese Medical University