Depressive Disorder, MajorPhase 2ACUfNIRSNCT04272476
The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy
A Phase 2 study testing acupuncture and moxibustion and Fluoxetine in people with Depressive Disorder, Major, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study evaluates the activation on prefrontal cortex with acupuncture and moxibustion for major depressive disorder.Half of participants will receive the treatment of acupuncture and moxibustion, while the other participants will receive the fluoxetine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- acupuncture and moxibustion and Fluoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2019
- Phase
- Phase 2
- 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
- diagnostic criteria of CCMD-3 and DSM-4 depression;
- the score of PHQ-9 should be equal to or more than 15 points; the score of Hamilton Depression Rating Scale should be more than 18 points;
- without any drug treatment over the past 3 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 610000
About this study
Official title: The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy (ACUfNIRS)
This study evaluates the activation on prefrontal cortex with acupuncture and moxibustion for major depressive disorder.Half of participants will receive the treatment of acupuncture and moxibustion, while the other participants will receive the fluoxetine.
Read the detailed description
Major depressive disorder (MDD) is a psychiatric condition with high morbidity, disability, suicide and recurrence rate and become the hot and difficult topics in the medical study. Given the unsatisfactory response rates of many FDA-approved antidepressants, acupuncture is increasingly considered an important alternative therapy. A large number of clinical trials have confirmed that acupuncture is a generally safe, effective, and well-tolerated therapy for depression, but for MDD, the acupuncture clinical trials were only reported out of China. According to the clinical symptoms in patients with MDD, the chief TCM patterns are liver qi constraint and heart yang insufficiency, and the secondary TCM patterns are blood stasis, qi and blood deficiency. So we propose to combine acupuncture with moxibustion and select Baihui (DU20), shenting(DU24), Neiguan (PC6), Hegu (LI4), Taichong (LV3), Zusanli(ST36), Zhongwan (RN 12) and Gaunyuan (RN4) to Soothe the Liver, regulating the heart, warm the yang qi, boost qi and invigorate blood for MDD. We hypothesize that the acupuncture's antidepressant effect is based on the neural network reconstructing mechanism through studying the cerebral cortex function, hippocampal synaptic plasticity, Neurons electrophysiological change. We will employ multi-disciplinary methods in neuropsychology, neuroimaging, computer science, and electrophysiology to explore the important mechanism underlying acupuncture and moxibustion treating MDD.
- Conditions
- Depressive Disorder, Major
- Being tested
- acupuncture and moxibustion, Fluoxetine
- Keywords
- Acupuncture, Moxibustion, Major Depressive Disorder, MDD, Neural Network Reconstruction, cerebral function, functional near infrared spectroscopy (fNIRS) imaging
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupuncture and moxibustionOther
FluoxetineDrug
Also called Prozac
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture and moxibustion | Experimental | Acupuncture points: Baihui(GV 20), Mingmen(GV 4), Bilateral Neiguan(PC 6), Bilateral Shenmen(HT 7), Bilateral Hegu(LI 4), Bilateral Zusanli(ST 36), Bilateral Taichong(LR 3). Each treatment takes about thirty minutes,3 times a week(treatment on Monday, Wednesday and Friday) for 8 weeks. Receives: Other: acupuncture and moxibustion |
| Western medicine | Active comparator | Fluoxetine 20 mg capsule by mouth every day for 8 weeks. Receives: Drug: Fluoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hamilton score as a measure of depressive degree
Evaluating the patient's depressive degree
Measured: 1, 2, 4, 6, 8 weeks after treatment
The fNIRS score as a measure of prefrontal oxyhemoglobin
Evaluating the patient's prefrontal oxyhemoglobin
Measured: 1, 2, 4, 6, 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study startJan 2014
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Principal investigator, Li ying, Chengdu University of Traditional Chinese Medicine
- Investigators
- Wu Junmei, Doctor, Principal investigator, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272476
- Sponsor's protocol ID
- ChengduUTCM
- Acronym
- ACUfNIRS
- Status last verified
- Feb 2020
- First submitted
- 31 Mar 2015
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Activation on Prefrontal Cortex With Acupuncture and Moxibustion for Major Depressive Disorder: A Study of Functional Near Infrared Spectroscopy (ACUfNIRS)
- ClinicalTrials.gov ID
- NCT04272476
- Acronym / sponsor ID
- ACUfNIRS / ChengduUTCM
- Conditions
- Depressive Disorder, Major
- Keywords
- Acupuncture, Moxibustion, Major Depressive Disorder, MDD, Neural Network Reconstruction, cerebral function, functional near infrared spectroscopy (fNIRS) imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 17 Feb 2020 (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.
This study evaluates the activation on prefrontal cortex with acupuncture and moxibustion for major depressive disorder.Half of participants will receive the treatment of acupuncture and moxibustion, while the other participants will receive the fluoxetine.
Detailed description
Major depressive disorder (MDD) is a psychiatric condition with high morbidity, disability, suicide and recurrence rate and become the hot and difficult topics in the medical study. Given the unsatisfactory response rates of many FDA-approved antidepressants, acupuncture is increasingly considered an important alternative therapy. A large number of clinical trials have confirmed that acupuncture is a generally safe, effective, and well-tolerated therapy for depression, but for MDD, the acupuncture clinical trials were only reported out of China. According to the clinical symptoms in patients with MDD, the chief TCM patterns are liver qi constraint and heart yang insufficiency, and the secondary TCM patterns are blood stasis, qi and blood deficiency. So we propose to combine acupuncture with moxibustion and select Baihui (DU20), shenting(DU24), Neiguan (PC6), Hegu (LI4), Taichong (LV3), Zusanli(ST36), Zhongwan (RN 12) and Gaunyuan (RN4) to Soothe the Liver, regulating the heart, warm the yang qi, boost qi and invigorate blood for MDD. We hypothesize that the acupuncture's antidepressant effect is based on the neural network reconstructing mechanism through studying the cerebral cortex function, hippocampal synaptic plasticity, Neurons electrophysiological change. We will employ multi-disciplinary methods in neuropsychology, neuroimaging, computer science, and electrophysiology to explore the important mechanism underlying acupuncture and moxibustion treating MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture and moxibustion | Experimental | Other: acupuncture and moxibustionAcupuncture points: Baihui(GV 20), Mingmen(GV 4), Bilateral Neiguan(PC 6), Bilateral Shenmen(HT 7), Bilateral Hegu(LI 4), Bilateral Zusanli(ST 36), Bilateral Taichong(LR 3). Each treatment takes about thirty minutes,3 times a week(treatment on Monday, Wednesday and Friday) for 8 weeks. |
| Western medicine | Active comparator | Drug: FluoxetineFluoxetine 20 mg capsule by mouth every day for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnostic criteria of CCMD-3 and DSM-4 depression;
- the score of PHQ-9 should be equal to or more than 15 points; the score of Hamilton Depression Rating Scale should be more than 18 points;
- without any drug treatment over the past 3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| acupuncture and moxibustion | Other | Acupuncture and moxibustion |
| FluoxetineAlso: Prozac | Drug | Western medicine |
Primary outcome
The Hamilton score as a measure of depressive degree
Time frame: 1, 2, 4, 6, 8 weeks after treatment
Evaluating the patient's depressive degree
The fNIRS score as a measure of prefrontal oxyhemoglobin
Time frame: 1, 2, 4, 6, 8 weeks after treatment
Evaluating the patient's prefrontal oxyhemoglobin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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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.
Wu Junmei, Doctor principal investigator
Chengdu University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing acupuncture and moxibustion and Fluoxetine in people with Depressive Disorder, Major, run by Chengdu University of Traditional Chinese Medicine 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 3 inclusion and 0 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: finished, as of the sponsor's last update on 17 Feb 2020. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hamilton score as a measure of depressive degree (time frame: 1, 2, 4, 6, 8 weeks after treatment). The study lists 2 primary outcomes in all. 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 17 Feb 2020.