Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

Overview

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.

Full Title of Study: “Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2018

Interventions

  • Device: 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.
  • Other: 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.
  • Drug: 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Montgomery-Asberg Depression Rating Scale Change
    • Time Frame: 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 Measures

  • SF-McGill Pain Questionnaire
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China Academy of Chinese Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Peijing Rong, The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences – China Academy of Chinese Medical Sciences
  • Overall Official(s)
    • Peijing Rong, Dotor, Study Director, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
    • Zhangjing Zhang, Dotor, Study Director, The School of Chinese Medicine, The University of Hong Kong
  • Overall Contact(s)
    • Peijing Rong, Dotor, 01064089301, drrongpj@163.com

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