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

NCT04272476 | Completed Phase 2

• 1 other identifier: ChengduUTCM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major

Keywords

Acupuncture; Moxibustion; Major Depressive Disorder; MDD; Neural Network Reconstruction; cerebral function; functional near infrared spectroscopy (fNIRS) imaging

Outcome Measures

Primary Outcomes (2)

• The Hamilton score as a measure of depressive degree

  Evaluating the patient's depressive degree

  1, 2, 4, 6, 8 weeks after treatment

• The fNIRS score as a measure of prefrontal oxyhemoglobin

  Evaluating the patient's prefrontal oxyhemoglobin

  1, 2, 4, 6, 8 weeks after treatment

Other Outcomes (1)

• The pHQ-9 score

  Screening criteria

Study Arms (2)

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.

Other: acupuncture and moxibustion

Western medicine

ACTIVE COMPARATOR

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

Drug: Fluoxetine

Interventions

acupuncture and moxibustion OTHER

Acupuncture and moxibustion

Fluoxetine DRUG

Also known as: Prozac

Western medicine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Acupuncture Therapy; Moxibustion; Fluoxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Propylamines; Amines; Organic Chemicals

Study Officials

• Wu Junmei, Doctor

  Chengdu University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: February 17, 2020
• Study Start: January 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

CN (1)