Major Depressive DisorderNCT05106868
Acupuncture for Patients With Major Depressive Disorder
A study testing acupuncture in people with Major Depressive Disorder, run by Chengdu University of Traditional Chinese Medicine.
Trial summary
Several studies investigating acupuncture for major depressive disorder (MDD) have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of acupuncture for MDD. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 30 Jun 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed participants aged between 18 to 60 years;
- participants diagnosed with mild to moderate major depressive disorder(MDD), and meet the diagnostic criteria of mild to moderate MDD according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition (DSM-5);
- participants with score of HAMD-24 between 8 to 35;
- participants without anti-depressive medication more than 3 months;
- participants willing to comply with the study protocol;
- participants willing to sign informed consent form.
Who cannot join
- participants with severe medical visceral condition and chronic diseases, such as hypertension, coronary heart disease, hyperthyroidism, hypothyroidism or diabetes and other endocrine system diseases;
- participants with brain organic diseases: such as birth injury, trauma, encephalitis, tumor, etc.;
- participants with Peripheral nerve and muscular system diseases;
- participants with severe anxiety, obsessive-compulsive disorder, or a history of mania or hypomania;
- Recently taken drugs that may cause mood disorders;
- Severe bleeding tendency, allergic constitution and skin disease patients;
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- pregnant or lactation women;
- Persons with visual and hearing disabilities;
- Participants with pacemakers, deep brain stimulators, vagus nerve stimulators, metal internal fixators, etc
- participate in other clinical trials at the same time
Trial locations and contacts
No sites are listed yet.
Rongjiang Jin contact
About this study
Official title: Acupuncture for Patients With Major Depressive Disorder: Study Protocol of a Randomized Controlled Trial
Several studies investigating acupuncture for major depressive disorder (MDD) have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of acupuncture for MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- acupuncture
- Keywords
- acupuncture, major depressive disorder, randomized controlled trial
- 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.
acupunctureDevice
Acupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the acupoints on body to treat diseases.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | 5 sessions of acupuncture per week for 4 weeks. In each session, acupuncture will be applied bilaterally on acupoints. We will use transcutaneous electric acupoints stimulation (HANS; Han's acupoints nerve stimulator, HANS-200, Nanjing, China) to stimulate the acupoints. Each session will last 30 minutes. Receives: Device: acupuncture |
| sham acupuncture | Sham comparator | 5 sessions of sham acupuncture per week for 4 weeks. In each session, acupuncture will be applied bilaterally on non-acupoints. We will use transcutaneous electric acupoints stimulation (HANS; Han's acupoints nerve stimulator, HANS-200, Nanjing, China) to stimulate the non-acupoints. Each session will last 30 minutes. Receives: Device: acupuncture |
| waiting-list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
score of Hamilton Depression Rating Scale-24
Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on the Hamilton Depression Rating Scale (HAMD)-24
Measured: change from baseline to 4 weeks after intervention, after follow-up(4 week)
Secondary outcomes (11)
score of self-rating depression scale
Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on self-rating depression scale (SDS)
Measured: baseline, after intervention(4 week), after follow-up(4 week)
score of Hamilton Anxiety Rating Scale
Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on Hamilton Anxiety Rating Scale (HAMA)
Measured: baseline, after intervention(4 week) , after follow-up(4 week)
score of Social Disability Screening Schedule
change of score of Social Disability Screening Schedule (SDSS)
Measured: baseline, after intervention(4 week) , after follow-up(4 week)
score of Pittsburgh sleep quality index (PSQI)
change of score of Pittsburgh sleep quality index (PSQI)
Measured: baseline, after intervention(4 week) , after follow-up(4 week)
motor threshold (MT)
motor threshold (MT) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer
Measured: baseline, after intervention(4 week) , after follow-up(4 week)
Intra-cortical facilitation (ICF)
Intra-cortical facilitation (ICF) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer
Measured: baseline, after intervention(4 week) , after follow-up(4 week)
cortical resting period (CSP)
cortical resting period (CSP) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer [Time Frame: baseline, after intervention(4 week), after follow-up(4 week)]
Measured: baseline, after intervention(4 week) , after follow-up(4 week)
intra-cortical inhibition (ICI)
intra-cortical inhibition (ICI) measured by Brain Ultimate Combined with MEB-2312 EMG/evoked potentiometer
Measured: baseline, after intervention(4 week) , after follow-up(4 week)
IAPS Evoked Event-related Potentials (ERP)
IAPS Evoked Event-related Potentials (ERP)
Measured: baseline, after intervention(4 week), after follow-up(4 week)
Evoked Event-related Potentials (ERP) in TMS-EEG
Evoked Event-related Potentials (ERP) in TMS-EEG
Measured: baseline, after intervention(4 week), after follow-up(4 week)
Adverse events
Adverse events
Measured: during intervention(4 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Nov 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Qin, Chengdu University of Traditional Chinese Medicine
- Investigators
- Jian Huang, Study chair, Institute of Science and Technology Development, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106868
- Sponsor's protocol ID
- 2019-1273
- Status last verified
- Oct 2021
- First submitted
- 25 Oct 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Patients With Major Depressive Disorder: Study Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05106868
- Acronym / sponsor ID
- 2019-1273
- Conditions
- Major Depressive Disorder
- Keywords
- acupuncture, major depressive disorder, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 4 Nov 2021 (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.
Several studies investigating acupuncture for major depressive disorder (MDD) have been carried out. However, investigators found the results were in high heterogeneity and poor methodological quality. Thus, investigators intend to provide high quality of the effectiveness and safety of acupuncture for MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Device: acupuncture5 sessions of acupuncture per week for 4 weeks. In each session, acupuncture will be applied bilaterally on acupoints. We will use transcutaneous electric acupoints stimulation (HANS; Han's acupoints nerve stimulator, HANS-200, Nanjing, China) to stimulate the acupoints. Each session will last 30 minutes. |
| sham acupuncture | Sham comparator | Device: acupuncture5 sessions of sham acupuncture per week for 4 weeks. In each session, acupuncture will be applied bilaterally on non-acupoints. We will use transcutaneous electric acupoints stimulation (HANS; Han's acupoints nerve stimulator, HANS-200, Nanjing, China) to stimulate the non-acupoints. Each session will last 30 minutes. |
| waiting-list | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Right-handed participants aged between 18 to 60 years;
- participants diagnosed with mild to moderate major depressive disorder(MDD), and meet the diagnostic criteria of mild to moderate MDD according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition (DSM-5);
- participants with score of HAMD-24 between 8 to 35;
- participants without anti-depressive medication more than 3 months;
- participants willing to comply with the study protocol;
Key exclusion criteria (10 listed)
- participants with severe medical visceral condition and chronic diseases, such as hypertension, coronary heart disease, hyperthyroidism, hypothyroidism or diabetes and other endocrine system diseases;
- participants with brain organic diseases: such as birth injury, trauma, encephalitis, tumor, etc.;
- participants with Peripheral nerve and muscular system diseases;
- participants with severe anxiety, obsessive-compulsive disorder, or a history of mania or hypomania;
- Recently taken drugs that may cause mood 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 |
|---|---|---|
| acupunctureAcupuncture is a form of alternative medicine and a component of traditional Chinese medicine (TCM) in which thin needles are inserted into the acupoints on body to treat diseases. | Device | acupuncture, sham acupuncture |
Primary outcome
score of Hamilton Depression Rating Scale-24
Time frame: change from baseline to 4 weeks after intervention, after follow-up(4 week)
Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on the Hamilton Depression Rating Scale (HAMD)-24
11 secondary outcomes
score of self-rating depression scale
Time frame: baseline, after intervention(4 week), after follow-up(4 week)
score of Hamilton Anxiety Rating Scale
Time frame: baseline, after intervention(4 week) , after follow-up(4 week)
score of Social Disability Screening Schedule
Time frame: baseline, after intervention(4 week) , after follow-up(4 week)
score of Pittsburgh sleep quality index (PSQI)
Time frame: baseline, after intervention(4 week) , after follow-up(4 week)
motor threshold (MT)
Time frame: baseline, after intervention(4 week) , after follow-up(4 week)
Intra-cortical facilitation (ICF)
Time frame: baseline, after intervention(4 week) , after follow-up(4 week)
cortical resting period (CSP)
Time frame: baseline, after intervention(4 week) , after follow-up(4 week)
intra-cortical inhibition (ICI)
Time frame: baseline, after intervention(4 week) , after follow-up(4 week)
IAPS Evoked Event-related Potentials (ERP)
Time frame: baseline, after intervention(4 week), after follow-up(4 week)
Evoked Event-related Potentials (ERP) in TMS-EEG
Time frame: baseline, after intervention(4 week), after follow-up(4 week)
Adverse events
Time frame: during intervention(4 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Rongjiang Jin contact
Jian Huang study chair
Institute of Science and Technology Development, Sichuan University
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Major Depressive Disorder, run by Chengdu University of Traditional Chinese Medicine.
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 10 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 4 Nov 2021. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Zhong Zheng, PhD (18980601861, zhengzhong1963@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
score of Hamilton Depression Rating Scale-24 (time frame: change from baseline to 4 weeks after intervention, after follow-up(4 week)). 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 4 Nov 2021.