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临床试验/NCT04272476
NCT04272476已完成2 期

The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy (ACUfNIRS)

Chengdu University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
The Hamilton score as a measure of depressive degree

研究概览

简要总结

This study evaluates the activation on prefrontal cortex with acupuncture and moxibustion for major depressive disorder.Half of participants will receive the treatment of acupuncture and moxibustion, while the other participants will receive the fluoxetine.

详细描述

Major depressive disorder (MDD) is a psychiatric condition with high morbidity, disability, suicide and recurrence rate and become the hot and difficult topics in the medical study. Given the unsatisfactory response rates of many FDA-approved antidepressants, acupuncture is increasingly considered an important alternative therapy. A large number of clinical trials have confirmed that acupuncture is a generally safe, effective, and well-tolerated therapy for depression, but for MDD, the acupuncture clinical trials were only reported out of China. According to the clinical symptoms in patients with MDD, the chief TCM patterns are liver qi constraint and heart yang insufficiency, and the secondary TCM patterns are blood stasis, qi and blood deficiency. So we propose to combine acupuncture with moxibustion and select Baihui (DU20), shenting(DU24), Neiguan (PC6), Hegu (LI4), Taichong (LV3), Zusanli(ST36), Zhongwan (RN 12) and Gaunyuan (RN4) to Soothe the Liver, regulating the heart, warm the yang qi, boost qi and invigorate blood for MDD. We hypothesize that the acupuncture's antidepressant effect is based on the neural network reconstructing mechanism through studying the cerebral cortex function, hippocampal synaptic plasticity, Neurons electrophysiological change. We will employ multi-disciplinary methods in neuropsychology, neuroimaging, computer science, and electrophysiology to explore the important mechanism underlying acupuncture and moxibustion treating 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 (Participant)

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

入选标准

  • diagnostic criteria of CCMD-3 and DSM-4 depression;
  • the score of PHQ-9 should be equal to or more than 15 points; the score of Hamilton Depression Rating Scale should be more than 18 points;
  • without any drug treatment over the past 3 months

排除标准

  • 未提供

研究组 & 干预措施

Acupuncture and moxibustion

Experimental

Acupuncture points: Baihui(GV 20), Mingmen(GV 4), Bilateral Neiguan(PC 6), Bilateral Shenmen(HT 7), Bilateral Hegu(LI 4), Bilateral Zusanli(ST 36), Bilateral Taichong(LR 3). Each treatment takes about thirty minutes,3 times a week(treatment on Monday, Wednesday and Friday) for 8 weeks.

干预措施: acupuncture and moxibustion (Other)

Western medicine

Active Comparator

Fluoxetine 20 mg capsule by mouth every day for 8 weeks.

干预措施: Fluoxetine (Drug)

结局指标

主要结局

The Hamilton score as a measure of depressive degree

时间窗: 1, 2, 4, 6, 8 weeks after treatment

Evaluating the patient's depressive degree

The fNIRS score as a measure of prefrontal oxyhemoglobin

时间窗: 1, 2, 4, 6, 8 weeks after treatment

Evaluating the patient's prefrontal oxyhemoglobin

次要结局

未报告次要终点

研究者

发起方
Chengdu University of Traditional Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Li ying

Professor

Chengdu University of Traditional Chinese Medicine

研究点 (1)

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