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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03282110
Other study ID # ChinaACMS-3
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received August 28, 2017
Last updated November 6, 2017
Start date November 30, 2017
Est. completion date June 30, 2019

Study information

Verified date September 2017
Source China Academy of Chinese Medical Sciences
Contact Peijing Rong, Dotor
Phone 01064089301
Email drrongpj@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 30, 2019
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China Academy of Chinese Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Other Salivary cortisol levels 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 baseline and 8 weeks
Other Physiological indexes Including blood pressure, ECG, respiration, pulse check, blood routine, blood biochemistry, urine analysis to see if there is any change during treatment baseline and 8 weeks
Other Adverse events that are related to treatment Measure the incidence of adverse events of acupuncture such as fainting during acupuncture treatment. baseline and 8 weeks
Primary 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. Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
Secondary 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 Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
Secondary 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. Baseline and 4 weeks, baseline and 8 weeks
Secondary 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 Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
Secondary 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. Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
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