Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain

NCT03282110 | Unknown Early Phase 1

• 1 other identifier: ChinaACMS-3
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depression; Psychoneurotic; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• SF-McGill Pain Questionnaire

  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

  Baseline and 4 weeks, baseline and 8 weeks

• Pittsburgh Sleep Quality Index

  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)

  Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks

Other Outcomes (3)

• Salivary cortisol levels

  baseline and 8 weeks

• Physiological indexes

  baseline and 8 weeks

• Adverse events that are related to treatment

  baseline and 8 weeks

Study Arms (2)

ta-VNS & Electro-acupuncture

EXPERIMENTAL

1. Device:ta-VNS(transcutaneous vagus nerve stimulation):2 times per day,5 consecutive days per week for two months 2. Other:Electro-acupuncture:3 times per week, once every other day for two months

Device: ta-VNS; Other: Electro-acupuncture

Citalopram

ACTIVE COMPARATOR

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

Interventions

ta-VNS DEVICE

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.

Also known as: transcutaneous vagus nerve stimulation

ta-VNS & Electro-acupuncture

Electro-acupuncture OTHER

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.

ta-VNS & Electro-acupuncture

Citalopram DRUG

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.

Also known as: brand name：Cipramil, SFDA J20130028

Citalopram

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

MeSH Terms

Conditions

Depression; Pain

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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 DIRECTOR

Central Study Contacts

Peijing Rong, Dotor

CONTACT

01064089301; drrongpj@163.com

Zhangjin Zhang, Dotor

CONTACT

+86 18307556273; zhangzj@hku.hk

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The deputy director of Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 13, 2017
• Study Start: November 30, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2019
• Last Updated: November 7, 2017

Record last verified: 2017-09