Major DepressionNCT06750640

Acupoint Thermal Radiation Characteristics in Adolescents with MDD

An observational study of Major Depression, run by Xiaomei Shao 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 12 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Major Depression
What is being tested?: Infrared thermography
How many people: 100 participants
Where: 1 siteChina
Study dates: 5 Mar 2022to 30 Nov 2024
Phase: Observational
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 12 to 17 years
All sexes
Healthy volunteers accepted
Child

Study population: The diagnostic criteria of MDD were based on criteria proposed by the International Classification of Diseases 10th Edition (ICD-10). Healthy control participants were determined by a recent depression screening report for confirming their mental health conditions.

Who may be able to join

12years≤ age<18 years;
SDS score <53;
Adolescents with normal cognitive function can cooperate with the study;
Adolescents and guardians agree to the study plan and sign the informed consent form.
Inclusion criteria for the major depression disorder participants:
12years≤ age<18 years;

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Self-rating Depression Scale (SDS) score ≥ 53;
Language, cognition and communication ability are normal;
Patients and guardians agree to the study plan and sign the informed consent form.

Who cannot join

Exclusion criteria both for the healthy control participants and major depression disorder participants:
Severe anxiety, schizophrenia, or other serious mental illnesses;
There are pigmentation, redness, infection or scarring on the skin at the site of detection;
Patients with severe systemic diseases and their complications, serious infections, and major diseases of viscera, tissues, and systems;
Female patients who were pregnant or lactating;
Female patients who were during, or in proximity (±2 days) to their menstruation or ovulation;

Show all 9Show fewer

Patients with a body temperature ≥37.3°C;
Inability to cooperate during the examination;
Participating in any other clinical 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: Acupoint Thermal Radiation Characteristics in Adolescents with Major Depressive Disorder and Establishment of Diagnostic Model

Modern studies have confirmed that skin temperature changes at acupoints when the body is under pathological conditions. This suggests that changes in the thermal radiation characteristics of acupoints can objectively respond to the symptoms of a disease. In this study, the investigators first evaluated reproducibility of acupoint temperature measurement by IRT. Secondly, the investigators explored the thermal radiation characteristics of MDD-related acupoints, built the diagnostic model for adolescent depression severity and the diagnostic model for MDD in adolescents based on acupoint temperature. Our research findings will provide new ideas, methods and visualisations for early screening, auxiliary diagnosis and condition assessment of MDD in adolescents.

Read the detailed description

A total of 100 subjects were included, 60 adolescent with MDD (MDD group) and 40 healthy controls (HC group). All subjects accepted IRT detection.The random selection of 30 adolescent with MDD allowed the collection of the bilateral same name acupoint temperatures. Intra- and inter-observer reproducibility for the patients were examined in some randomly selected patients by 2 investigators and 2 investigators both made 2 independent measurements in a week. 30 MDD subjects were detected the bilateral same name acupoint temperatures.

Conditions: Major Depression
Being tested: Infrared thermography
Keywords: Major Depression Disorder, acupoint temperature, adolescent
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.

Infrared thermographyDiagnostic test
A thermograph (NEC InfRec R450, Avio Infrared Technologies Co., Ltd., Tokyo) was used to record thermal images. The infrared camera was fixed on a tripod 1 m away from the subject to ensure that no shaking movements or vibrations occurred during the recording of thermal images. MDD related acupoints on the inner and outer sides of the limbs were detected. Appropriate body position was selected according to the different parts to be detected. Using the automatic interval saving shooting mode, one thermal picture was taken at 10-s intervals, 3 pictures were taken for each subject.

Study groups in NCT06750640
Study group	Role	What they receive
Healthy Control group		There were 40 healthy control participants in the Healthy Control group. Receives: Diagnostic Test: Infrared thermography
Major Depression Disorder group		There were 60 MDD patients in the MDD group. All MDD adolescents received at least one IRT test. 26 MDD adolescents were detected by 2 investigators and 2 investigators both made 2 independent measurements in a week. 30 MDD subjects were detected the bilateral same name acupoint temperatures. Receives: Diagnostic Test: Infrared thermography

What is being measured

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

Acupoint emperature
Temperature of acupoints was measured by infrared thermography (IRT). IRT was not be performed on female subjects during their menstrual and ovulatory periods.
Measured: Baseline

Secondary outcomes (1)

The Self-Rating Depression Scale (SDS) Scores
The standard score is the total of all scores multiplied by 1.25 to the nearest whole number on this scale, which has 20 questions. A standard score below 53 is normal; 53-62 is mild depression; 63-72 is moderate depression; 72 or more is severe depression.
Measured: Baseline

Timeline

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

5 Mar 202230 Nov 2024

First posted27 Dec 2024
Study start5 Mar 2022
Primary completion30 Jun 2024
Study completion30 Nov 2024

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 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: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06750640
Sponsor's protocol ID: 2022ZX010-IRT
Status last verified: Dec 2024
First submitted: 20 Dec 2024
Last updated: 31 Dec 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Qu S, Tu M, Jin J, Wu X, Xiong S, Chen N, Yu Z, Fang J, Shao X. Acupoint temperature as a biomarker: infrared thermography in the diagnosis of adolescents with major depressive disorder. Front Psychiatry. 2026 Apr 29;17:1806676. doi: 10.3389/fpsyt.2026.1806676. eCollection 2026.
PubMed 42137538

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 Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupoint Thermal Radiation Characteristics in Adolescents with Major Depressive Disorder and Establishment of Diagnostic Model
ClinicalTrials.gov ID: NCT06750640
Acronym / sponsor ID: 2022ZX010-IRT
Conditions: Major Depression
Keywords: Major Depression Disorder, acupoint temperature, adolescent
Study type: Observational
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Xiaomei ShaoUniversity, hospital or other
Collaborators: Zhejiang Provincial Tongde Hospital, First People's Hospital of Hangzhou
Study start: 5 Mar 2022 (actual)
Primary completion: 30 Jun 2024 (actual)
Study completion: 30 Nov 2024 (actual)
First posted: 27 Dec 2024 (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

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Healthy Control group	–	Diagnostic Test: Infrared thermographyThere were 40 healthy control participants in the Healthy Control group.
Major Depression Disorder group	–	Diagnostic Test: Infrared thermographyThere were 60 MDD patients in the MDD group. All MDD adolescents received at least one IRT test. 26 MDD adolescents were detected by 2 investigators and 2 investigators both made 2 independent measurements in a week. 30 MDD subjects were detected the bilateral same name acupoint temperatures.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: The diagnostic criteria of MDD were based on criteria proposed by the International Classification of Diseases 10th Edition (ICD-10). Healthy control participants were determined by a recent depression screening report for confirming their mental health conditions.

Key inclusion criteria (9 listed)

12years≤ age<18 years;
SDS score <53;
Adolescents with normal cognitive function can cooperate with the study;
Adolescents and guardians agree to the study plan and sign the informed consent form.
12years≤ age<18 years;

Key exclusion criteria (9 listed)

Exclusion criteria both for the healthy control participants and major depression disorder participants:
Severe anxiety, schizophrenia, or other serious mental illnesses;
There are pigmentation, redness, infection or scarring on the skin at the site of detection;
Patients with severe systemic diseases and their complications, serious infections, and major diseases of viscera, tissues, and systems;
Female patients who were pregnant or lactating;

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
Infrared thermographyA thermograph (NEC InfRec R450, Avio Infrared Technologies Co., Ltd., Tokyo) was used to record thermal images. The infrared camera was fixed on a tripod 1 m away from the subject to ensure that no shaking movements or vibrations occurred during the recording of thermal images. MDD related acupoints on the inner and outer sides of the limbs were detected. Appropriate body position was selected according to the different parts to be detected. Using the automatic interval saving shooting mode, one thermal picture was taken at 10-s intervals, 3 pictures were taken for each subject.	Diagnostic test	Healthy Control group, Major Depression Disorder group

Primary outcome

Acupoint emperature
Time frame: Baseline
Temperature of acupoints was measured by infrared thermography (IRT). IRT was not be performed on female subjects during their menstrual and ovulatory periods.

1 secondary outcome

The Self-Rating Depression Scale (SDS) Scores
Time frame: Baseline

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 31 Dec 2024.
Derived from this study: PubMed 42137538Qu S, Tu M, Jin J, Wu X, Xiong S, Chen N, Yu Z, Fang J, Shao X. Acupoint temperature as a biomarker: infrared thermography in the diagnosis of adolescents with major depressive disorder. Front Psychiatry. 2026 Apr 29;17:1806676. doi: 10.3389/fpsyt.2026.1806676. eCollection 2026.
Individual participant dataSharing planned: No

Related trials for Major Depression

Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
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Not yet recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depression, run by Xiaomei Shao 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 9 inclusion and 9 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 31 Dec 2024. 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?

Acupoint emperature (time frame: Baseline). 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 NCT06750640, 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 31 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.