DepressionEarly Phase 1NCT03607331
Auricular Concha Electro-acupuncture for the Treatment of Depression
A Early Phase 1 study testing Auricular vagus nerve stimulation and Citalopram in people with Depression and Depressive Symptom, run by China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The objective of this study was to compare the therapeutic effects of Auricular Concha Electro-acupuncture and Citalopram on patients with major depressive disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Depressive Symptom, Depressive Disorder
- What is being tested?
- Auricular vagus nerve stimulation 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
- 106 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2018to 1 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis is consistent with DSM-V diagnostic criteria for mild-to- moderate depression;
- Patients with the first onset or recurrence of the disease have not been treated with antidepressant or without antidepressant treatment before treatment for 3 months;
- Age from 18 to 65 years old, with no gender;
- Outpatient;
- 17 Item Hamilton Depression Rating Scale (HAMD-17) score > 7, and <24;
- Signed informed consent.
Who cannot join
- In addition to depression, it conforms to the diagnostic criteria of any psychiatric disease;
- Patients with a history of schizophrenia or other mental illness;
- Patients with cognitive impairment or personality disorder;
- In the past 6 months, patients who have met the DSM-V criteria for substance related and addictive disorders;
- Before entering the group, any other antidepressant treatment is being accepted;
- Patients with serious body disease, such as heart disease (namely Ⅱ and Ⅱ above cardiac function) , obvious abnormalities of liver and kidney function (Biomarkers more than 3 times normal);
- Serious suicidal ideation or suicidal behavior.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Acupuncture and Moxibustion
Beijing, Beijing Municipality
Yufeng Zhao, PhD, 86 13651115411, snowmanzhao@163.com
About this study
Official title: Auricular Concha Electro-acupuncture for the Treatment of Mild to Moderate Depression: A Randomized Controlled Trial
The objective of this study was to compare the therapeutic effects of Auricular Concha Electro-acupuncture and Citalopram on patients with major depressive disorder (MDD).
Read the detailed description
In this study, 106 patients with MDD were randomly divided into the auricular concha electro-acupuncture group and the citalopram group by the evaluation blind method and randomized control design, and were treated for 8 weeks and 4 weeks follow-up. In No. 0, 2, 4, 6, 8, 10, 12 Weekend, Hamilton Rating Scale for Depression-17 Item (HAM-D17) and Hamilton Anxiety Rating Scale (Ham-A) were performed for all patients. During the No. 0/8 weekend, patients were tested and analyzed for peripheral blood NE, 5-HT, DA, Cortisol, ACTH, GABA, glutamic acid, BDNF and BFGF, and the brain is also examined and analyzed by fMRI.
- Conditions
- Depression, Depressive Symptom, Depressive Disorder
- Being tested
- Auricular vagus nerve stimulation, Citalopram
- Keywords
- depression, electro-acupuncture, auricular concha
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular vagus nerve stimulationDevice
Also called vagus nerve stimulation at auricular concha
Auricular vagus nerve stimulation is a typical representative of TCM modernization.
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 |
|---|---|---|
| Auricular vagus nerve stimulation | Experimental | Auricular Concha Electro-acupuncture: twice a day at home as required, once in the morning and once in the evening, with 5 consecutive days per week for two months Receives: Device: Auricular vagus nerve stimulation |
| 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.
17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change
The Hamilton Depression Rating Scale has proven useful for determining the level of depression before, during, and after treatment. It is based on the clinician's interview with the patient and probes symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss. The interview and scoring takes about 15 minutes. The rater enters a number for each symptom construct that ranges from 0 (not present) to 4 (extreme symptoms). The higher the total score is, the worse it is.The total score of 17HAMD more than 24 is defined as major depression, more than 17 but less than 24 is mild or moderate depression, and less than 7 is no depression.
Measured: Baseline and 1 week,baseline and 2th weeks,baseline and 4th weeks,baseline and 6th weeks,baseline and 8th weeks, baseline and 10th weeks after treatment, baseline and 12th weeks after treatment
Secondary outcomes (10)
14 Item Hamilton Anxiety Scale (HAMA-14) Score Change
This widely-used interview scale measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. The higher the total score is, the worse it is. The total score of HAMA-14 more than 29 is defined as severe anxiety, more than 21 but less than 29 is obvious anxiety, more than 14 but less than 21 is certain anxiety, more than 7 but less than 14 is likely to be anxiety, and less than 6 is no anxiety.
Measured: Baseline and 1 week,baseline and 2th weeks,baseline and 4th weeks,baseline and 6th weeks,baseline and 8th weeks, baseline and 10th weeks after treatment, baseline and 12th weeks after treatment
NE(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
5-HT(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
DA(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
Cortisol(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
ACTH(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
GABA(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
Glutamate(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
BDNF(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
bFGF(ng/L)
Biochemical indicators of peripheral blood
Measured: Baseline and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start17 Sep 2018
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 106 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607331
- Sponsor's protocol ID
- ChinaACMS-5
- Status last verified
- Apr 2019
- First submitted
- 15 May 2018
- Last updated
- 22 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Concha Electro-acupuncture for the Treatment of Mild to Moderate Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03607331
- Acronym / sponsor ID
- ChinaACMS-5
- Conditions
- Depression, Depressive Symptom, Depressive Disorder
- Keywords
- depression, electro-acupuncture, auricular concha
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 31 Jul 2018 (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.
The objective of this study was to compare the therapeutic effects of Auricular Concha Electro-acupuncture and Citalopram on patients with major depressive disorder (MDD).
Detailed description
In this study, 106 patients with MDD were randomly divided into the auricular concha electro-acupuncture group and the citalopram group by the evaluation blind method and randomized control design, and were treated for 8 weeks and 4 weeks follow-up. In No. 0, 2, 4, 6, 8, 10, 12 Weekend, Hamilton Rating Scale for Depression-17 Item (HAM-D17) and Hamilton Anxiety Rating Scale (Ham-A) were performed for all patients. During the No. 0/8 weekend, patients were tested and analyzed for peripheral blood NE, 5-HT, DA, Cortisol, ACTH, GABA, glutamic acid, BDNF and BFGF, and the brain is also examined and analyzed by fMRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular vagus nerve stimulation | Experimental | Device: Auricular vagus nerve stimulationAuricular Concha Electro-acupuncture: twice a day at home as required, once in the morning and once in the evening, with 5 consecutive days per week 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 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The diagnosis is consistent with DSM-V diagnostic criteria for mild-to- moderate depression;
- Patients with the first onset or recurrence of the disease have not been treated with antidepressant or without antidepressant treatment before treatment for 3 months;
- Age from 18 to 65 years old, with no gender;
- Outpatient;
- 17 Item Hamilton Depression Rating Scale (HAMD-17) score > 7, and <24;
Key exclusion criteria (7 listed)
- In addition to depression, it conforms to the diagnostic criteria of any psychiatric disease;
- Patients with a history of schizophrenia or other mental illness;
- Patients with cognitive impairment or personality disorder;
- In the past 6 months, patients who have met the DSM-V criteria for substance related and addictive disorders;
- Before entering the group, any other antidepressant treatment is being accepted;
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 |
|---|---|---|
| Auricular vagus nerve stimulationAlso: vagus nerve stimulation at auricular conchaAuricular vagus nerve stimulation is a typical representative of TCM modernization. | Device | Auricular vagus nerve stimulation |
| 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
17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change
Time frame: Baseline and 1 week,baseline and 2th weeks,baseline and 4th weeks,baseline and 6th weeks,baseline and 8th weeks, baseline and 10th weeks after treatment, baseline and 12th weeks after treatment
The Hamilton Depression Rating Scale has proven useful for determining the level of depression before, during, and after treatment. It is based on the clinician's interview with the patient and probes symptoms such as depressed mood, guilty feelings, suicide, sleep disturbances, anxiety levels and weight loss. The interview and scoring takes about 15 minutes. The rater enters a number for each symptom construct that ranges from 0 (not present) to 4 (extreme symptoms). The higher the total score is, the worse it is.The total score of 17HAMD more than 24 is defined as major depression, more than 17 but less than 24 is mild or moderate depression, and less than 7 is no depression.
10 secondary outcomes
14 Item Hamilton Anxiety Scale (HAMA-14) Score Change
Time frame: Baseline and 1 week,baseline and 2th weeks,baseline and 4th weeks,baseline and 6th weeks,baseline and 8th weeks, baseline and 10th weeks after treatment, baseline and 12th weeks after treatment
NE(ng/L)
Time frame: Baseline and 8th week
5-HT(ng/L)
Time frame: Baseline and 8th week
DA(ng/L)
Time frame: Baseline and 8th week
Cortisol(ng/L)
Time frame: Baseline and 8th week
ACTH(ng/L)
Time frame: Baseline and 8th week
GABA(ng/L)
Time frame: Baseline and 8th week
Glutamate(ng/L)
Time frame: Baseline and 8th week
BDNF(ng/L)
Time frame: Baseline and 8th week
bFGF(ng/L)
Time frame: Baseline and 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Auricular vagus nerve stimulation and Citalopram in people with Depression and Depressive Symptom, run by China Academy of Chinese Medical Sciences at 1 site in China.
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 7 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 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17 Item Hamilton Depression Rating Scale (HAMD-17) Score Change (time frame: Baseline and 1 week,baseline and 2th weeks,baseline and 4th weeks,baseline and 6th weeks,baseline and 8th weeks, baseline and 10th weeks after treatment, baseline and 12th weeks after treatment). 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 22 Apr 2019.