Clinical trial NCT04272476: The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy
Official title: The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy (ACUfNIRS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Keywords: Acupuncture
Moxibustion
Major Depressive Disorder
MDD
Neural Network Reconstruction
cerebral function
functional near infrared spectroscopy (fNIRS) imaging
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2020-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: The Hamilton score as a measure of depressive degree
timeFrame: 1, 2, 4, 6, 8 weeks after treatment
measure: The fNIRS score as a measure of prefrontal oxyhemoglobin
timeFrame: 1, 2, 4, 6, 8 weeks after treatment
Secondary outcomes:
Other outcomes:
measure: The pHQ-9 score
timeFrame: Screening criteria
Locations:
city: Chengdu
country: China
facility: Teaching Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
Study officials:
affiliation: Chengdu University of Traditional Chinese Medicine
name: Wu Junmei, Doctor
role: PRINCIPAL_INVESTIGATOR
References: