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NCT Number: NCT04272476

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupuncture and moxibustion

Other

Fluoxetine

Drug

Other names: Prozac

Primary outcomes

  1. 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

  2. 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

Other outcomes

  1. The pHQ-9 score

    Time frame: Screening criteria

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

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

Acronym: ACUfNIRS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Feb 17, 2020
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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