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Clinical Trials/NCT04272476
NCT04272476CompletedPhase 2

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 site in 1 country20 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
The Hamilton score as a measure of depressive degree

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Intervention: acupuncture and moxibustion (Other)

Western medicine

Active Comparator

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

Intervention: Fluoxetine (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Chengdu University of Traditional Chinese Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Li ying

Professor

Chengdu University of Traditional Chinese Medicine

Study Sites (1)

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