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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
  Purpose
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.

Condition Intervention Phase
Depression; Psychoneurotic Pain Device: ta-VNS Other: Electro-acupuncture Drug: Citalopram Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Peijing Rong, China Academy of Chinese Medical Sciences:

Primary Outcome 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 Outcome 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 60
Anticipated Study Start Date: November 30, 2017
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.
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
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282110


Contacts
Contact: Peijing Rong, Dotor 01064089301 drrongpj@163.com
Contact: Zhangjin Zhang, Dotor +86 18307556273 zhangzj@hku.hk

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
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
  More Information

Responsible Party: Peijing Rong, The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03282110     History of Changes
Other Study ID Numbers: ChinaACMS-3
First Submitted: August 28, 2017
First Posted: September 13, 2017
Last Update Posted: November 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents