NCT05106868Unknown不适用
Acupuncture for Patients With Major Depressive Disorder: Study Protocol of a Randomized Controlled Trial
Chengdu University of Traditional Chinese Medicine0 个研究点目标入组 123 人开始时间: 2021年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 123
- 主要终点
- score of Hamilton Depression Rating Scale-24
研究概览
简要总结
Several studies investigating acupuncture for major depressive disorder (MDD) have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of acupuncture for MDD.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right-handed participants aged between 18 to 60 years;
- •participants diagnosed with mild to moderate major depressive disorder(MDD), and meet the diagnostic criteria of mild to moderate MDD according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition (DSM-5);
- •participants with score of HAMD-24 between 8 to 35;
- •participants without anti-depressive medication more than 3 months;
- •participants willing to comply with the study protocol;
- •participants willing to sign informed consent form.
排除标准
- •participants with severe medical visceral condition and chronic diseases, such as hypertension, coronary heart disease, hyperthyroidism, hypothyroidism or diabetes and other endocrine system diseases;
- •participants with brain organic diseases: such as birth injury, trauma, encephalitis, tumor, etc.;
- •participants with Peripheral nerve and muscular system diseases;
- •participants with severe anxiety, obsessive-compulsive disorder, or a history of mania or hypomania;
- •Recently taken drugs that may cause mood disorders;
- •Severe bleeding tendency, allergic constitution and skin disease patients;
- •pregnant or lactation women;
- •Persons with visual and hearing disabilities;
- •Participants with pacemakers, deep brain stimulators, vagus nerve stimulators, metal internal fixators, etc
- •participate in other clinical trials at the same time
结局指标
主要结局
score of Hamilton Depression Rating Scale-24
时间窗: change from baseline to 4 weeks after intervention, after follow-up(4 week)
Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on the Hamilton Depression Rating Scale (HAMD)-24
次要结局
- score of self-rating depression scale(baseline, after intervention(4 week), after follow-up(4 week))
- score of Pittsburgh sleep quality index (PSQI)(baseline, after intervention(4 week) , after follow-up(4 week))
- cortical resting period (CSP)(baseline, after intervention(4 week) , after follow-up(4 week))
- IAPS Evoked Event-related Potentials (ERP)(baseline, after intervention(4 week), after follow-up(4 week))
- Evoked Event-related Potentials (ERP) in TMS-EEG(baseline, after intervention(4 week), after follow-up(4 week))
- motor threshold (MT)(baseline, after intervention(4 week) , after follow-up(4 week))
- Intra-cortical facilitation (ICF)(baseline, after intervention(4 week) , after follow-up(4 week))
- score of Hamilton Anxiety Rating Scale(baseline, after intervention(4 week) , after follow-up(4 week))
- score of Social Disability Screening Schedule(baseline, after intervention(4 week) , after follow-up(4 week))
- intra-cortical inhibition (ICI)(baseline, after intervention(4 week) , after follow-up(4 week))
- Adverse events(during intervention(4 week))
研究者
Di Qin
Professor
Chengdu University of Traditional Chinese Medicine
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