Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

Early Phase 1

• Conditions: Depression; Psychoneurotic; Pain
• Interventions: Device: ta-VNS; Drug: Citalopram; Other: Electro-acupuncture

• Registration Number: NCT03282110
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2017-08-28
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-11
• Study First Posted: 2017-09-13
• Last Update Submitted: 2017-11-06
• Last Update Posted: 2017-11-07
• Study Start: 2017-11-30
• Primary Completion: 2018-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ta-VNS & Electro-acupuncture	ta-VNS	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
ta-VNS & Electro-acupuncture	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
Citalopram	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

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale Change	Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks	Measure the severity of depressive episodes in patients with mood disorders, It contents ten items, and each item is scored 0-6.(0=no depression,6=depression as bad as can be), yielding a total between 0 and 60.

Secondary Outcome Measures

Name	Time	Method
SF-McGill Pain Questionnaire	Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks	Measure pain in 3 ways:1)pain rating indexes: pain intensity from feeling and emotional aspects, it includes fifteen items and each item is scored 0-3(0=no pain 3=severe) 2)present pain intensity, scored 0-5(0=no pain, 5=intense pain) 3)VAS: visual analog scale
SF-36 Health Survey Questionnaire	Baseline and 4 weeks, baseline and 8 weeks	Measure the self-reported living quality.It has eight sections:the physiological function, physiological function, the body pain, general health, energy, social function, emotional function and mental health.It consists of eight scaled scores, which are the weighted sums of the questions in their section.
Pittsburgh Sleep Quality Index	Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks	A self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating seven components that produce one global score
Hamilton Anxiety Rating Scale(HAMA)	Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks	A psychological questionnaire used by clinicians to rate the severity of a patient's anxiety.Each of the 14 items contains some symptoms, and each group of symptoms is rated on a scale of zero to four, with four being the most severe.