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

Depressive Disorder, Major Clinical Trial

— ACUfNIRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272476
• Other study ID #: ChengduUTCM
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: Chengdu University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Other:
• acupuncture and moxibustion

Drug:
• Fluoxetine

Locations

Country	Name	City	State
China	Teaching Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu University of Traditional Chinese Medicine	Massachusetts General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The pHQ-9 score		Screening criteria
Primary	The Hamilton score as a measure of depressive degree	Evaluating the patient's depressive degree	1, 2, 4, 6, 8 weeks after treatment
Primary	The fNIRS score as a measure of prefrontal oxyhemoglobin	Evaluating the patient's prefrontal oxyhemoglobin	1, 2, 4, 6, 8 weeks after treatment