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
About this trial
This is an interventional treatment trial for Depression; Psychoneurotic
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
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
NCT ID
NCT03282110
First Posted
August 28, 2017
Last Updated
November 6, 2017
Sponsor
China Academy of Chinese Medical Sciences
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
Learn more about this trial
Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain
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