Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03282110|
Recruitment Status : Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression; Psychoneurotic Pain||Device: ta-VNS Other: Electro-acupuncture Drug: Citalopram||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study|
|Estimated Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: ta-VNS & Electro-acupuncture
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 Name: transcutaneous vagus nerve stimulation
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
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 Name: brand name：Cipramil, SFDA J20130028
- Montgomery-Asberg Depression Rating Scale Change [ Time Frame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks ]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.
- SF-McGill Pain Questionnaire [ Time Frame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks ]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
- SF-36 Health Survey Questionnaire [ Time Frame: Baseline and 4 weeks, baseline and 8 weeks ]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.
- Pittsburgh Sleep Quality Index [ Time Frame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks ]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
- Hamilton Anxiety Rating Scale(HAMA) [ Time Frame: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks ]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.
- Salivary cortisol levels [ Time Frame: baseline and 8 weeks ]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
- Physiological indexes [ Time Frame: baseline and 8 weeks ]Including blood pressure, ECG, respiration, pulse check, blood routine, blood biochemistry, urine analysis to see if there is any change during treatment
- Adverse events that are related to treatment [ Time Frame: baseline and 8 weeks ]Measure the incidence of adverse events of acupuncture such as fainting during acupuncture treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282110
|Contact: Peijing Rong, Dotorfirstname.lastname@example.org|
|Contact: Zhangjin Zhang, Dotor||+86 email@example.com|
|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|