Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

China Academy of Chinese Medical Sciences

Status and phase: Unknown; Early Phase 1

Conditions: Depression; Psychoneurotic; Pain

Treatments: Drug: Citalopram; Other: Electro-acupuncture; Device: ta-VNS

Study type: Interventional

Funder types: Other

Identifiers

NCT03282110

ChinaACMS-3

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

ta-VNS & Electro-acupuncture

Experimental group

Description:

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

Treatment:

Device: ta-VNS

Other: Electro-acupuncture

Citalopram

Active Comparator group

Description:

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

Treatment:

Drug: Citalopram