Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

Pain Clinical Trial

Official title:

Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03282110
• Other study ID #: ChinaACMS-3
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression; Psychoneurotic
• Depressive Disorder
• Pain

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