Clinical trial NCT03282110: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Depression; Psychoneurotic
Pain
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale Change
timeFrame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
Secondary outcomes:
measure: SF-McGill Pain Questionnaire
timeFrame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
measure: SF-36 Health Survey Questionnaire
timeFrame: Baseline and 4 weeks, baseline and 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
measure: Hamilton Anxiety Rating Scale(HAMA)
timeFrame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
Other outcomes:
measure: Salivary cortisol levels
timeFrame: baseline and 8 weeks
measure: Physiological indexes
timeFrame: baseline and 8 weeks
measure: Adverse events that are related to treatment
timeFrame: baseline and 8 weeks
Locations:
Study officials:
affiliation: Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
name: Peijing Rong, Dotor
role: STUDY_DIRECTOR
affiliation: The School of Chinese Medicine, The University of Hong Kong
name: Zhangjing Zhang, Dotor
role: STUDY_DIRECTOR
References: