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Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

This study is not yet open for participant recruitment.
Verified September 2017 by Peijing Rong, China Academy of Chinese Medical Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT03282110
First Posted: September 13, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Peijing Rong, China Academy of Chinese Medical Sciences
August 28, 2017
September 13, 2017
November 7, 2017
November 30, 2017
June 30, 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03282110 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
  • Salivary cortisol levels [ Time Frame: baseline and 8 weeks ]
    Serum cortisol levels positively correlated with the severity of depression, so that the saliva should be collected before and after treatment. Acquisition time of saliva: 7:30~8:30 am and 3:00-4:00 p.m
  • Physiological indexes [ Time Frame: baseline and 8 weeks ]
    Including blood pressure, ECG, respiration, pulse check, blood routine, blood biochemistry, urine analysis to see if there is any change during treatment
  • Adverse events that are related to treatment [ Time Frame: baseline and 8 weeks ]
    Measure the incidence of adverse events of acupuncture such as fainting during acupuncture treatment.
Same as current
 
Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain
Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study
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.
Not Provided
Interventional
Early Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Depression; Psychoneurotic
  • Pain
  • 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 Name: transcutaneous vagus nerve stimulation
  • 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.
    Other Name: brand name:Cipramil, SFDA J20130028
  • Experimental: 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
    Interventions:
    • Device: ta-VNS
    • Other: Electro-acupuncture
  • 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
    Intervention: Drug: Citalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
June 30, 2019
June 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact: Peijing Rong, Dotor 01064089301 drrongpj@163.com
Contact: Zhangjin Zhang, Dotor +86 18307556273 zhangzj@hku.hk
Not Provided
 
 
NCT03282110
ChinaACMS-3
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Peijing Rong, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
Not Provided
Study Director: Peijing Rong, Dotor Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Study Director: Zhangjing Zhang, Dotor The School of Chinese Medicine, The University of Hong Kong
China Academy of Chinese Medical Sciences
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP