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Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

Primary Purpose

Depression; Psychoneurotic, Pain

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
ta-VNS
Electro-acupuncture
Citalopram
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression; Psychoneurotic

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ta-VNS & Electro-acupuncture

    Citalopram

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Montgomery-Asberg Depression Rating Scale Change
    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
    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
    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
    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)
    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.

    Full Information

    First Posted
    August 28, 2017
    Last Updated
    November 6, 2017
    Sponsor
    China Academy of Chinese Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03282110
    Brief Title
    Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain
    Official Title
    Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 30, 2017 (Anticipated)
    Primary Completion Date
    June 30, 2018 (Anticipated)
    Study Completion Date
    June 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Academy of Chinese Medical Sciences

    4. Oversight

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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression; Psychoneurotic, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ta-VNS & Electro-acupuncture
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Citalopram
    Arm Type
    Active Comparator
    Arm 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
    Intervention Type
    Device
    Intervention Name(s)
    ta-VNS
    Other Intervention Name(s)
    transcutaneous vagus nerve stimulation
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Electro-acupuncture
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Citalopram
    Other Intervention Name(s)
    brand name：Cipramil, SFDA J20130028
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Montgomery-Asberg Depression Rating Scale Change
    Description
    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.
    Time Frame
    Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
    Secondary Outcome Measure Information:
    Title
    SF-McGill Pain Questionnaire
    Description
    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
    Time Frame
    Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
    Title
    SF-36 Health Survey Questionnaire
    Description
    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.
    Time Frame
    Baseline and 4 weeks, baseline and 8 weeks
    Title
    Pittsburgh Sleep Quality Index
    Description
    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
    Time Frame
    Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
    Title
    Hamilton Anxiety Rating Scale(HAMA)
    Description
    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.
    Time Frame
    Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
    Other Pre-specified Outcome Measures:
    Title
    Salivary cortisol levels
    Description
    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
    Time Frame
    baseline and 8 weeks
    Title
    Physiological indexes
    Description
    Including blood pressure, ECG, respiration, pulse check, blood routine, blood biochemistry, urine analysis to see if there is any change during treatment
    Time Frame
    baseline and 8 weeks
    Title
    Adverse events that are related to treatment
    Description
    Measure the incidence of adverse events of acupuncture such as fainting during acupuncture treatment.
    Time Frame
    baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Peijing Rong, Dotor
    Phone
    01064089301
    Email
    drrongpj@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhangjin Zhang, Dotor
    Phone
    +86 18307556273
    Email
    zhangzj@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peijing Rong, Dotor
    Organizational Affiliation
    Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Zhangjing Zhang, Dotor
    Organizational Affiliation
    The School of Chinese Medicine, The University of Hong Kong
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

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