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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2019

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.

Interventions

  • Other: acupuncture and moxibustion
  • Drug: Fluoxetine

Arms, Groups and Cohorts

  • Experimental: Acupuncture and moxibustion
    • 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.
  • Active Comparator: Western medicine
    • Fluoxetine 20 mg capsule by mouth every day for 8 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • The Hamilton score as a measure of depressive degree
    • Time Frame: 1, 2, 4, 6, 8 weeks after treatment
    • Evaluating the patient’s depressive degree
  • The fNIRS score as a measure of prefrontal oxyhemoglobin
    • Time Frame: 1, 2, 4, 6, 8 weeks after treatment
    • Evaluating the patient’s prefrontal oxyhemoglobin

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chengdu University of Traditional Chinese Medicine
  • Collaborator
    • Massachusetts General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Li ying, Professor – Chengdu University of Traditional Chinese Medicine
  • Overall Official(s)
    • Wu Junmei, Doctor, Principal Investigator, Chengdu University of Traditional Chinese Medicine

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