Depression; PsychoneuroticEarly Phase 1NCT03282110
Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain
A Early Phase 1 study testing ta-VNS, Electro-acupuncture and Citalopram in people with Depression; Psychoneurotic and Pain, run by China Academy of Chinese Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Depression; Psychoneurotic, Pain
- What is being tested?
- ta-VNS, Electro-acupuncture and Citalopram
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2017to 30 Jun 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Depression; Psychoneurotic, Pain
- Being tested
- ta-VNS, Electro-acupuncture, Citalopram
- Medical subject headings
- Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ta-VNSDevice
Also called transcutaneous vagus nerve stimulation
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.
Electro-acupunctureOther
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.
CitalopramDrug
Also called brand name：Cipramil, SFDA J20130028
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline and 1 week,baseline and 2 weeks,baseline and 4 weeks,baseline and 6 weeks,baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start30 Nov 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression; PsychoneuroticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peijing Rong, China Academy of Chinese Medical Sciences
- Investigators
- Peijing Rong, Dotor, Study director, Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical SciencesZhangjing Zhang, Dotor, Study director, The School of Chinese Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03282110
- Sponsor's protocol ID
- ChinaACMS-3
- Status last verified
- Sep 2017
- First submitted
- 28 Aug 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Acupuncture for Depressive Disorder With Comorbid Psychogenic Pain: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03282110
- Acronym / sponsor ID
- ChinaACMS-3
- Conditions
- Depression; Psychoneurotic, Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 30 Nov 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 13 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ta-VNS & Electro-acupuncture | Experimental | Device: ta-VNS, Other: Electro-acupuncture1. 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 |
| Citalopram | Active comparator | Drug: Citalopramcitalopram 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ta-VNSAlso: transcutaneous vagus nerve stimulationThe 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. | Device | ta-VNS & Electro-acupuncture |
| Electro-acupunctureone 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. | Other | ta-VNS & Electro-acupuncture |
| CitalopramAlso: brand name：Cipramil, SFDA J20130028Citalopram 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. | Drug | Citalopram |
Primary outcome
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.
4 secondary outcomes
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
SF-36 Health Survey Questionnaire
Time frame: Baseline and 4 weeks, baseline and 8 weeks
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peijing Rong, Dotor study director
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
Zhangjing Zhang, Dotor study director
The School of Chinese Medicine, The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ta-VNS, Electro-acupuncture and Citalopram in people with Depression; Psychoneurotic and Pain, run by China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peijing Rong, Dotor (01064089301, drrongpj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.