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

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
acupuncture and moxibustion
Fluoxetine
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Acupuncture, Moxibustion, Major Depressive Disorder, MDD, Neural Network Reconstruction, cerebral function, functional near infrared spectroscopy (fNIRS) imaging

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture and moxibustion

Western medicine

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The Hamilton score as a measure of depressive degree
Evaluating the patient's depressive degree
The fNIRS score as a measure of prefrontal oxyhemoglobin
Evaluating the patient's prefrontal oxyhemoglobin

Secondary Outcome Measures

Full Information

First Posted
March 31, 2015
Last Updated
February 13, 2020
Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04272476
Brief Title
The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy
Acronym
ACUfNIRS
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Acupuncture, Moxibustion, Major Depressive Disorder, MDD, Neural Network Reconstruction, cerebral function, functional near infrared spectroscopy (fNIRS) imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture and moxibustion
Arm Type
Experimental
Arm Description
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.
Arm Title
Western medicine
Arm Type
Active Comparator
Arm Description
Fluoxetine 20 mg capsule by mouth every day for 8 weeks.
Intervention Type
Other
Intervention Name(s)
acupuncture and moxibustion
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Primary Outcome Measure Information:
Title
The Hamilton score as a measure of depressive degree
Description
Evaluating the patient's depressive degree
Time Frame
1, 2, 4, 6, 8 weeks after treatment
Title
The fNIRS score as a measure of prefrontal oxyhemoglobin
Description
Evaluating the patient's prefrontal oxyhemoglobin
Time Frame
1, 2, 4, 6, 8 weeks after treatment
Other Pre-specified Outcome Measures:
Title
The pHQ-9 score
Time Frame
Screening criteria

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu Junmei, Doctor
Organizational Affiliation
Chengdu University of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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