Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Depression; Psychoneurotic
• Intervention / Treatment: Device: ta-VNS; Other: Electro-acupuncture; Drug: Citalopram

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ta-VNS & Electro-acupuncture; 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	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 Names: 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 Names: brand name：Cipramil, SFDA J20130028

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Anticipated): November 30, 2017
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: ChinaACMS-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No