Major Depressive DisorderNCT05524519

Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder

A study testing Basic treatment, PSA and TSA in people with Major Depressive Disorder, run by The Third Affiliated hospital of Zhejiang Chinese Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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?: Basic treatment, PSA and TSA
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteChina
Study dates: 1 Nov 2022to 31 Dec 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

HC who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
18 ≤ age ≤60 years, male or female;
Participants have clear consciousness and could communicate with others normally;
Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves.
Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for MDD;
18 ≤ age ≤60, male or female;
Participants have clear consciousness and could communicate with others normally;
Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves.

Who cannot join

Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
Participants have a mental illness, alcohol dependence, or a history of drug abuse;
Pregnant or lactating participants;
Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
The skin at the test site of participants has scars, hyperpigmentation, red and swollen;

Show all 15Show fewer

Participants are participating in other trials.
Participants with serious primary diseases of cardiovascular, respiratory, digestive, urinary, hematological, endocrine, neurological disease, and other serious primary diseases, and the disease cannot be effectively controlled clinically;
MDD caused by organic mental disorders, schizophrenia, bipolar disorder, psychoactive substances, and non-addictive substances;
Participants with suicidal tendencies;
Pregnant or lactating participants;
Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;
The skin at the test site of participants has scars, hyperpigmentation, red and swollen. IRT is not be performed on female subjects during their menstrual and ovulatory periods;
Participants are participating in other trials.

Trial locations and contacts

1 site in 1 country.

China1 site

the Third affiliated hospital of Zhejiang Chinese Medical university
Hangzhou, Zhejiang

Other trials in China

About this study

Official title: Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder: a Prospective, Multicentre, Randomized, Controlled Trial

Acupoints are the stimulus points and reactive points for acupuncture to treat diseases. Therefore, this study is designed to detect the pain threshold and temperature of biological specificities of acupoints in healthy control (HC) participants and major depressive disorder (MDD) participants by using pressure pain threshold gauge (PTG) and infrared thermography (IRT). Based on the results of the PTG and IRT tests, the potentially superior acupoints for the treatment of MDD will be selected separately. Then, different acupoint groups selected based on different biological specificities tests will be used for clinical treatment to evaluate the clinical efficacy of intradermal acupuncture (IA) for MDD based on changes in the biological specificities of acupoints.

Read the detailed description

Part 1: This study will include 50 patients with MDD (MDD group) and 50 HC participants (HC group). PTG and IRT, respectively, will be adopted to assess 2 kinds of biological specificity of MDD-related acupoints: pain sensitivity specificity and thermal specificity. Based on the results of the PTG and IRT tests, the potentially superior acupoints for the treatment of MDD will be selected separately. After statistical analysis of the data from PTG and IRT tests, 4 pressure pain threshold strong response acupoints (PSA) and 4 temperature strong response acupoints (TSA) will be selected, respectively. This part of the trial began on January 10, 2022, and its registration number is NCT06114342.

Part 2: A total of 160 participants with MDD who meet the inclusion criteria will be included in the study. Patients with MDD who met the criteria will be randomly divided 1:1:1:1 into 4 groups: wait-listed treatment (WL) group, clinical common acupoint (CCA) group, TSA group, and PSA group. All participants received basic therapeutic medication for the use of one or more antidepressants. Dosing and dosage will be adjusted by a specialist. The Patient Health Questionnaire-9 (PHQ-9) and the MOS item short form health survey (SF-36) will be used as clinical efficacy outcome indicators, and each group's incidence of adverse effects will be observed. This study will investigate the effectiveness and safety of IA based on changes in the biological specificity of acupoints for MDD.

Conditions: Major Depressive Disorder
Being tested: Basic treatment, PSA, TSA, CCA
Keywords: Major depressive disorder, Intradermal acupuncture, Biological specificity
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.

Basic treatmentDrug
Also called Health education and medication
1. Health education: Properly explain the causes and precautions of the patient and instruct the patient to rest regularly. In addition, care should be enhanced to avoid accidents.
2. The basic therapeutic drug is the use of one or more antidepressants, such as oral 5-hydroxytryptamine reuptake inhibitors, dual inhibitors of pentraxin and norepinephrine reuptake, noradrenergic and specific pentraxinergic antidepressants, pentraxin receptor balance antagonists, tricyclic antidepressants, etc. If there is significant sleep disturbance, benzodiazepines may be added temporarily. Dosing and dosage will be adjusted by a specialist.
PSAProcedure or surgery
Also called Intradermal acupuncture in PSA
Four PSA selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.20*1.5m or φ0.20*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.
TSAProcedure or surgery
Also called Intradermal acupuncture in TSA
Four TSA selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.20*1.5m or φ0.20*1.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.
CCAProcedure or surgery
Also called Intradermal acupuncture in CCA
Acupoints: LR3 (Taichong), PC6 (Neiguan), SP6 (Sanyinjiao), and HT7 (Shengmen). PC6 and HT7 will use φ0.20*1.2mm acupuncture needle. LR3 and SP6 will use φ0.20*1.5m acupuncture needles. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.

Study groups in NCT05524519
Study group	Role	What they receive
WL group	Active comparator	This group will include 40 patients with MDD. Patients in this group will not receive IA treatment during the study period. When the study is over, they will receive 6 weeks of the same IA treatment as in the CCA group. Receives: Drug: Basic treatment
CCA group	Experimental	This group will include 40 patients with MDD who will be treated with basic treatment and IA. LR3, PC6, SP6, and HT7 will be selected for IA. Receives: Drug: Basic treatment; Procedure: CCA
TSA group	Experimental	This group will include 40 patients with MDD who will be treated with basic treatment and IA. TSA selected in the first part of the study will be stimulated. Receives: Drug: Basic treatment; Procedure: TSA
PSA group	Experimental	This group will include 40 patients with MDD who will be treated with basic treatment and IA. PSA selected in the first part of the study will be stimulated. Receives: Drug: Basic treatment; Procedure: PSA

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Patient Health Questionaire-9 Items (PHQ -9)
The PHQ-9 scale has a total of 9 questions, each with a score of 0-3 (none: 0; a few days: 1; more than half of the time: 2; almost every day: 3), with a total score of 0-27.
Measured: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.

Secondary outcomes (4)

Change in the MOS item short form health survey (SF-36)
The SF-36 scale evaluates the quality of healthy life into 8 dimensions, which are divided into two categories: physical health and mental health, namely physical function (PF), role physical (RP), body pain (BP), general health (GH), vitality (VT), social function (SF), role emotional (RE), mental health (MH).
Measured: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Temperature change of relevant sites
NEC R450 Infrared thermography will be used to record baseline temperature and the temperature change of relevant sites. The average temperature value of relevant sites in the six infrared thermograms is its base temperature.
Measured: Baseline, 6 weeks after treatment.
Pain sensitivity change of relevant sites
A pressure pain threshold gauge will be used to measure the local pain threshold (PT). The probe of the pain gauge will be placed vertically on the relevant test site, and the pressure will be applied slowly and steadily, and when the participant feels pain, the pressure will stop and the reading on the gauge is the PT. The average value of the PT of the same relevant test sites will be calculated as their base PT.
Measured: Baseline, 6 weeks after treatment.
Adverse Events
The adverse events that occurred during the study will be recorded, including symptoms, signs, the time of appearance, duration, degree of severity, treatment measures, and the course of treatment, and their correlation with the treatment will be evaluated.
Incidence of adverse events = number of cases of adverse events /total number of cases in the study.
Measured: through study completion (up to 10 weeks).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202231 Dec 2023

First posted1 Sep 2022
Study start1 Nov 2022
Primary completion31 Dec 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05524519
Sponsor's protocol ID: 2022ZX010-BIA
Status last verified: Aug 2025
First submitted: 30 Aug 2022
Last updated: 22 Aug 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tu M, Wu X, Qu S, Jin J, Chen N, Xiong S, Pei S, Li X, Shi Y, Hu H, Li X, Fang J, Shao X. The effective on intradermal acupuncture based on changes in biological specificity of acupoints for major depressive disorder: study protocol of a prospective, multicenter, randomized, controlled trial. Front Psychiatry. 2023 Jun 9;14:1183127. doi: 10.3389/fpsyt.2023.1183127. eCollection 2023.
PubMed 37441145

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intradermal Acupuncture Based on Changes in Biological Specificity of Acupoints for Major Depressive Disorder: a Prospective, Multicentre, Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT05524519
Acronym / sponsor ID: 2022ZX010-BIA
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder, Intradermal acupuncture, Biological specificity
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
Collaborators: Zhejiang Provincial Tongde Hospital, First People's Hospital of Hangzhou
Study start: 1 Nov 2022 (actual)
Primary completion: 31 Dec 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 1 Sep 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
WL group	Active comparator	Drug: Basic treatmentThis group will include 40 patients with MDD. Patients in this group will not receive IA treatment during the study period. When the study is over, they will receive 6 weeks of the same IA treatment as in the CCA group.
CCA group	Experimental	Drug: Basic treatment, Procedure: CCAThis group will include 40 patients with MDD who will be treated with basic treatment and IA. LR3, PC6, SP6, and HT7 will be selected for IA.
TSA group	Experimental	Drug: Basic treatment, Procedure: TSAThis group will include 40 patients with MDD who will be treated with basic treatment and IA. TSA selected in the first part of the study will be stimulated.
PSA group	Experimental	Drug: Basic treatment, Procedure: PSAThis group will include 40 patients with MDD who will be treated with basic treatment and IA. PSA selected in the first part of the study will be stimulated.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

HC who could provide a recent depression screening report, and confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine, or neurological disease;
18 ≤ age ≤60 years, male or female;
Participants have clear consciousness and could communicate with others normally;
Participants could understand the full study protocol and have high adherence. Written informed consent is signed by themselves.
Patients should meet the diagnostic criteria of the International Classification of Diseases 10th Edition (ICD-10) diagnostic criteria for MDD;

Key exclusion criteria (15 listed)

Participants with serious primary diseases of cardiovascular diseases, liver diseases, kidney diseases, urinary diseases, and hematological diseases;
Participants have a mental illness, alcohol dependence, or a history of drug abuse;
Pregnant or lactating participants;
Participants with intellectual disabilities who cannot cooperate with the questionnaire survey;
Participants with bleeding tendency, skin disease, allergic constitution, and allergic to adhesive tape;

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
Basic treatmentAlso: Health education and medication1. Health education: Properly explain the causes and precautions of the patient and instruct the patient to rest regularly. In addition, care should be enhanced to avoid accidents. 2. The basic therapeutic drug is the use of one or more antidepressants, such as oral 5-hydroxytryptamine reuptake inhibitors, dual inhibitors of pentraxin and norepinephrine reuptake, noradrenergic and specific pentraxinergic antidepressants, pentraxin receptor balance antagonists, tricyclic antidepressants, etc. If there is significant sleep disturbance, benzodiazepines may be added temporarily. Dosing and dosage will be adjusted by a specialist.	Drug	CCA group, PSA group, TSA group, WL group
PSAAlso: Intradermal acupuncture in PSAFour PSA selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.201.5m or φ0.201.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.	Procedure or surgery	PSA group
TSAAlso: Intradermal acupuncture in TSAFour TSA selected in the first part of the study will be stimulated. According to the position of the acupoints, choose a needle of φ0.201.5m or φ0.201.2mm. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.	Procedure or surgery	TSA group
CCAAlso: Intradermal acupuncture in CCAAcupoints: LR3 (Taichong), PC6 (Neiguan), SP6 (Sanyinjiao), and HT7 (Shengmen). PC6 and HT7 will use φ0.201.2mm acupuncture needle. LR3 and SP6 will use φ0.201.5m acupuncture needles. Press the needle to insert the acupoint vertically and retain it in the skin. After the intervention, the needle will be retained for 72 hours with a day of rest after removal. During needle retention, participants will be instructed to press the acupoints 3-4 times a day for about 1 minute each time, with the amount of stimulation as much as the patient can tolerate, at an interval of about 4 hours. A total of 10 treatment sessions will be performed for 6 weeks.	Procedure or surgery	CCA group

Primary outcome

Change in the Patient Health Questionaire-9 Items (PHQ -9)
Time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
The PHQ-9 scale has a total of 9 questions, each with a score of 0-3 (none: 0; a few days: 1; more than half of the time: 2; almost every day: 3), with a total score of 0-27.

4 secondary outcomes

Change in the MOS item short form health survey (SF-36)
Time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.
Temperature change of relevant sites
Time frame: Baseline, 6 weeks after treatment.
Pain sensitivity change of relevant sites
Time frame: Baseline, 6 weeks after treatment.
Adverse Events
Time frame: through study completion (up to 10 weeks).

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 22 Aug 2025.
Derived from this study: PubMed 37441145Tu M, Wu X, Qu S, Jin J, Chen N, Xiong S, Pei S, Li X, Shi Y, Hu H, Li X, Fang J, Shao X. The effective on intradermal acupuncture based on changes in biological specificity of acupoints for major depressive disorder: study protocol of a prospective, multicenter, randomized, controlled trial. Front Psychiatry. 2023 Jun 9;14:1183127. doi: 10.3389/fpsyt.2023.1183127. eCollection 2023.
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.

Xiaomei Shao, Ph.D principal investigator

The Third Affiliated hospital of Zhejiang Chinese Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Basic treatment, PSA and TSA in people with Major Depressive Disorder, run by The Third Affiliated hospital of Zhejiang Chinese Medical University 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 8 inclusion and 15 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 22 Aug 2025. 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.

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?

Change in the Patient Health Questionaire-9 Items (PHQ -9) (time frame: Baseline, 3 weeks after treatment, 6 weeks after treatment, at 4-week follow-up.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05524519, which also lists 1 linked publication.

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 Aug 2025.