Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

NCT ID: NCT03282110

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2019-06-30

Brief Summary

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Experimental and clinical studies have indicated that acupuncture has a good effect for depression and comorbid pain. The purpose of this research is to compare the effect of comprehensive electro-acupuncture therapy and western medicine citalopram for for depressive disorder with comorbid psychogenic pain. This research is a assessor blinded, randomized controlled trials. 60 patients will be randomly divided into comprehensive electro-acupuncture group and western medicine citalopram for 8 weeks treatment and the therapeutic effect is done at the end of 1,2,4,6,8 week.

Detailed Description

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Conditions

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Depression; Psychoneurotic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ta-VNS & Electro-acupuncture

1. Device:ta-VNS(transcutaneous vagus nerve stimulation):2 times per day,5 consecutive days per week for two months
2. Other:Electro-acupuncture:3 times per week, once every other day for two months

Group Type EXPERIMENTAL

ta-VNS

Intervention Type DEVICE

The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of depression.

Electro-acupuncture

Intervention Type OTHER

one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.

Citalopram

citalopram for oral administration; 10mg for the first 1-3 days, 20mg for the following 4-7 days;40mg for the left days within two months

Group Type ACTIVE_COMPARATOR

Citalopram

Intervention Type DRUG

Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.

Interventions

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ta-VNS

The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of depression.

Intervention Type DEVICE

Electro-acupuncture

one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.

Intervention Type OTHER

Citalopram

Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.

Intervention Type DRUG

Other Intervention Names

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transcutaneous vagus nerve stimulation brand name:Cipramil, SFDA J20130028

Eligibility Criteria

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Inclusion Criteria

* Conform with the diagnostic criteria of depression according to DIAGNOSTIC AND STATISTICAL MANUAL OF MENTAL DISORDERS (DSM-5TM)
* Age from 18 to 50 year-old
* Patients with the first onset depression
* Patients with mild-to-moderate depression scored 12-30 by Montgomery scale
* Patients with one psychogenic pain at least, and the degree of VAS is 3 or more
* Volunteer participants willing to cooperate and obeying the treatment

Exclusion Criteria

* Pregnant woman
* Patients with severe primary diseases and acute diseases of heart, brain, liver, kidney and hematopoietic systems and infectious disease, malignant tumor
* Patients who can't stop taking drugs according to the requirement in the treatment period
* Patients with a history of schizophrenia and other mental disorders
* Patients with cognitive impairment or personality disorders
* Patients have serious suicide idea or suicidal behavior
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Peijing Rong

The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peijing Rong, Dotor

Role: STUDY_DIRECTOR

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Zhangjing Zhang, Dotor

Role: STUDY_DIRECTOR

The School of Chinese Medicine, The University of Hong Kong

Central Contacts

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Peijing Rong, Dotor

Role: CONTACT

Phone: 01064089301

Email: [email protected]

Zhangjin Zhang, Dotor

Role: CONTACT

Phone: +86 18307556273

Email: [email protected]

Other Identifiers

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ChinaACMS-3

Identifier Type: -

Identifier Source: org_study_id