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

NCT ID: NCT04272476

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-12-31

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.

Conditions

Depressive Disorder, Major

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

acupuncture and moxibustion

Intervention Type: OTHER

Western medicine

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

Group Type: ACTIVE_COMPARATOR

Fluoxetine

Intervention Type: DRUG

Interventions

acupuncture and moxibustion

Intervention Type: OTHER

Fluoxetine

Intervention Type: DRUG

Other Intervention Names

Prozac

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Li ying

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wu Junmei, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chengdu University of Traditional Chinese Medicine

Locations

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

Countries

China

Other Identifiers

ChengduUTCM

Identifier Type: -

Identifier Source: org_study_id