Major Depressive DisorderNCT05024149
Assessing the Impact of Electroacupuncture on Facial Thermal Characteristics of Major Depressive Disorder Patients Based on Infrared Thermal Imaging Technology
A study testing infrared thermography (IRT) in people with Major Depressive Disorder and Infrared Thermography, run by Zhejiang Chinese Medical University at 1 site in China.
Trial summary
Three groups of subjects will be included: 20 subjects in the healthy control group, 20 subjects in the MDD electroacupuncture (EA) intervention group, and 20 subjects in the MDD waiting-list group (participants will receive no treatment within 4 weeks). 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, Infrared Thermography
- What is being tested?
- infrared thermography (IRT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Dec 2024
- 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
- Healthy subjects should provide a physical examination report within the last year, which could confirm they had not major systemic diseases, such as cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
- 18 ≤ age ≤ 60 years, both gender;
- Subjects have clear consciousness and could communicate with others normally;
- Subjects could understand the full study protocol and written informed consent is provided by themselves. Note: Subjects who meet the above four items will be included.
- Meeting the above diagnostic criteria for MDD;
- PHQ-9 score of 5 to 14, HAMD score of 21 to 35, and a diagnosis of mild or moderate depression by a specialist; (3)18 ≤ age ≤ 60 years, both gender;
- Patients have clear consciousness and could communicate with others normally; (5) Patients could understand the full study protocol and written informed consent is provided by themselves; (6) Those who did not use other therapies other than the basic treatment and this experimental therapy. The basic treatment refers to basic antidepressant medications under the supervision of a specialist. The basic antidepressant medications are Selective Serotonin Reuptake Inhibitors, Serotonin-Norepinephrine Reuptake Inhibitors, Norepinephrine-Dopamine Reuptake Inhibitors, Tricyclic antidepressants, Monoamine Oxidase Inhibitors. Note: Subjects who meet the above six items will be included.
Who cannot join
- Subjects suffering from mental illness, severe depression, alcohol dependence or a history of drug abuse;
- Subjects in pregnancy, lactation or menstrual period;
- Subjects have a fever;
- Subjects have visible skin damage or scars in the face;
- Subjects participating in other trials. Note: Subjects who meet any of the above will be excluded.
- Patients with bipolar disorder;
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- Patients with schizophrenia or other mental disorders;
- Patients with severe medical diseases, tumors or diseases of the central nervous system;
- Patients suffering from severe depressive episode with psychotic symptoms;
- Suicidal patients;
- Patients with seasonal depression;
- Patients with organic depression;
- Patients with alcohol or drug addicts;
- Patients using other therapies;
- Patients in pregnancy or lactation;
- Patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment;
- Patients with pacemakers;
- Patients who are not suitable for EA. Note: Subjects who meet any of the above will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Three groups of subjects will be included: 20 subjects in the healthy control group, 20 subjects in the MDD electroacupuncture (EA) intervention group, and 20 subjects in the MDD waiting-list group (participants will receive no treatment within 4 weeks). The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera. The average facial temperature and acupoints temperature will be analyzed and compared within 3 groups. In addition, the correlation between facial infrared radiation characteristics of MDD patients and emotional changes will be explored. Besides, the relative specificity of the two meridians will be investigated.
- Conditions
- Major Depressive Disorder, Infrared Thermography
- Being tested
- infrared thermography (IRT)
- 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 thermography (IRT)Other
The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Experimental | Subjects in this group will not undergo acupuncture intervention. For participants in the healthy control group, the IRT examination of the measurement sites will last for 3 minutes, with one thermal image taken every 10s. In the Healthy group, there will be two visits, and the first visit will be considered as the screening stage (i.e., demographic data recording, medical history taking, physical examination report review and recording on the day of enrollment) and the second visit will be considered as the detection stage (i.e., the day of enrollment). At the second visit, the subjects received the Self-rating depression scale (SDS), HAMD, and then the infrared thermographic images to be acquired. Receives: Other: infrared thermography (IRT) |
| MDD electroacupuncture intervention group | Experimental | Not described Receives: Other: infrared thermography (IRT) |
| MDD waiting-list group | Experimental | In this study, we used a waiting list control group. During the 4 weeks follow-up period, participants from the MDD waiting-list group had no contact with participants from the MDD EA intervention group and no access to the EA intervention. After the 4 weeks follow-up period, patients in the waiting list group received access to the EA intervention. Receives: Other: infrared thermography (IRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average facial temperature
Take the average facial temperature of 10 infrared images as the observation index, observe the change rule of the average temperature of MDD patient by comparing with healthy people.
Measured: Change from Baseline average facial temperature at 4 weeks
Secondary outcomes (2)
Infrared thermal images
Direct contrast comparisons of the approximate distribution area of the high temperature and low temperature zone of the face between healthy subjects versus MDD patients will be done using software analyses.
Measured: Change from Baseline average facial temperature at 4 weeks
Hamilton depression scale (HAMD)
This scale is performed by two trained raters to perform a Hamilton depression scale (HAMD), usually in the form of conversation and observation. After the examination, the two raters will score independently. HAMD score of 21 to 35 values, and higher scores mean a worse outcome.
Measured: HAMD will be performed in the first week, the second week and the fourth week to evaluate the severity of the disease and the treatment effect.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Jul 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Xiaoyu Li, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024149
- Sponsor's protocol ID
- 2020YKJ04
- Status last verified
- Jan 2023
- First submitted
- 12 Aug 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Electroacupuncture on Facial Thermal Characteristics of Major Depressive Disorder Patients Based on Infrared Thermal Imaging Technology
- ClinicalTrials.gov ID
- NCT05024149
- Acronym / sponsor ID
- 2020YKJ04
- Conditions
- Major Depressive Disorder, Infrared Thermography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 27 Aug 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.
Three groups of subjects will be included: 20 subjects in the healthy control group, 20 subjects in the MDD electroacupuncture (EA) intervention group, and 20 subjects in the MDD waiting-list group (participants will receive no treatment within 4 weeks). The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera. The average facial temperature and acupoints temperature will be analyzed and compared within 3 groups. In addition, the correlation between facial infrared radiation characteristics of MDD patients and emotional changes will be explored. Besides, the relative specificity of the two meridians will be investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group | Experimental | Other: infrared thermography (IRT)Subjects in this group will not undergo acupuncture intervention. For participants in the healthy control group, the IRT examination of the measurement sites will last for 3 minutes, with one thermal image taken every 10s. In the Healthy group, there will be two visits, and the first visit will be considered as the screening stage (i.e., demographic data recording, medical history taking, physical examination report review and recording on the day of enrollment) and the second visit will be considered as the detection stage (i.e., the day of enrollment). At the second visit, the subjects received the Self-rating depression scale (SDS), HAMD, and then the infrared thermographic images to be acquired. |
| MDD electroacupuncture intervention group | Experimental | Other: infrared thermography (IRT) |
| MDD waiting-list group | Experimental | Other: infrared thermography (IRT)In this study, we used a waiting list control group. During the 4 weeks follow-up period, participants from the MDD waiting-list group had no contact with participants from the MDD EA intervention group and no access to the EA intervention. After the 4 weeks follow-up period, patients in the waiting list group received access to the EA intervention. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy subjects should provide a physical examination report within the last year, which could confirm they had not major systemic diseases, such as cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
- 18 ≤ age ≤ 60 years, both gender;
- Subjects have clear consciousness and could communicate with others normally;
- Subjects could understand the full study protocol and written informed consent is provided by themselves. Note: Subjects who meet the above four items will be included.
- Meeting the above diagnostic criteria for MDD;
Key exclusion criteria (18 listed)
- Subjects suffering from mental illness, severe depression, alcohol dependence or a history of drug abuse;
- Subjects in pregnancy, lactation or menstrual period;
- Subjects have a fever;
- Subjects have visible skin damage or scars in the face;
- Subjects participating in other trials. Note: Subjects who meet any of the above will be excluded.
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 thermography (IRT)The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera. | Other | Healthy group, MDD electroacupuncture intervention group, MDD waiting-list group |
Primary outcome
Average facial temperature
Time frame: Change from Baseline average facial temperature at 4 weeks
Take the average facial temperature of 10 infrared images as the observation index, observe the change rule of the average temperature of MDD patient by comparing with healthy people.
2 secondary outcomes
Infrared thermal images
Time frame: Change from Baseline average facial temperature at 4 weeks
Hamilton depression scale (HAMD)
Time frame: HAMD will be performed in the first week, the second week and the fourth week to evaluate the severity of the disease and the treatment effect.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: Yes
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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?
A study testing infrared thermography (IRT) in people with Major Depressive Disorder and Infrared Thermography, run by 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 7 inclusion and 18 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 31 Jan 2023. 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?
Results are not available in the source record.
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?
Average facial temperature (time frame: Change from Baseline average facial temperature at 4 weeks). 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 31 Jan 2023.