NCT05024149Enrolling By Invitation不适用
Assessing the Impact of Electroacupuncture on Facial Thermal Characteristics of Major Depressive Disorder Patients Based on Infrared Thermal Imaging Technology
Zhejiang Chinese Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Average facial temperature
研究概览
简要总结
Three groups of subjects will be included: 20 subjects in the healthy control group, 20 subjects in the MDD electroacupuncture (EA) intervention group, and 20 subjects in the MDD waiting-list group (participants will receive no treatment within 4 weeks). The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera. The average facial temperature and acupoints temperature will be analyzed and compared within 3 groups. In addition, the correlation between facial infrared radiation characteristics of MDD patients and emotional changes will be explored. Besides, the relative specificity of the two meridians will be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, 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
- •Inclusion criteria for healthy subjects:
- •Healthy subjects should provide a physical examination report within the last year, which could confirm they had not major systemic diseases, such as cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
- •18 ≤ age ≤ 60 years, both gender;
- •Subjects have clear consciousness and could communicate with others normally;
- •Subjects could understand the full study protocol and written informed consent is provided by themselves. Note: Subjects who meet the above four items will be included.
- •Inclusion criteria for MDD patients:
- •Meeting the above diagnostic criteria for MDD;
- •PHQ-9 score of 5 to 14, HAMD score of 21 to 35, and a diagnosis of mild or moderate depression by a specialist; (3)18 ≤ age ≤ 60 years, both gender;
- •(4) Patients have clear consciousness and could communicate with others normally; (5) Patients could understand the full study protocol and written informed consent is provided by themselves; (6) Those who did not use other therapies other than the basic treatment and this experimental therapy. The basic treatment refers to basic antidepressant medications under the supervision of a specialist. The basic antidepressant medications are Selective Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitors, Norepinephrine-Dopamine Reuptake Inhibitors, Tricyclic antidepressants, Monoamine Oxidase Inhibitors. Note: Subjects who meet the above six items will be included.
排除标准
- •Exclusion criteria for healthy subjects:
- •Subjects suffering from mental illness, severe depression, alcohol dependence or a history of drug abuse;
- •Subjects in pregnancy, lactation or menstrual period;
- •Subjects have a fever;
- •Subjects have visible skin damage or scars in the face;
- •Subjects participating in other trials. Note: Subjects who meet any of the above will be excluded.
- •Exclusion criteria for MDD patients:
- •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 EA. Note: Subjects who meet any of the above will be excluded.
结局指标
主要结局
Average facial temperature
时间窗: Change from Baseline average facial temperature at 4 weeks
Take the average facial temperature of 10 infrared images as the observation index, observe the change rule of the average temperature of MDD patient by comparing with healthy people.
次要结局
- Infrared thermal images(Change from Baseline average facial temperature at 4 weeks)
- Hamilton depression scale (HAMD)(HAMD will be performed in the first week, the second week and the fourth week to evaluate the severity of the disease and the treatment effect.)
研究者
Xiaoyu Li
Attending Doctor
Zhejiang Chinese Medical University
研究点 (1)
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