the Objective Diagnosis of DepressionNCT07062666
A Multicentre Clinical Study
An observational study of the Objective Diagnosis of Depression, run by Zhongda Hospital.
Trial summary
This study intends to conduct a multi-center, large-sample clinical trial, aiming at using multi-channel near-infrared spectroscopy to detect the characteristics of brain Oxy-Hb changes over time during cognitive activation in patients with depression before treatment and in the gender - and age-matched control group… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- the Objective Diagnosis of Depression
- What is being tested?
- SSRIs and fNIRS
- Type of treatment
- Medical device
- How many people
- 2,250 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: depressive patients
Who may be able to join
- Aged 18-60 years old; ② Right-handed; ③ Meet the DSM-5 diagnostic criteria for depression; ④ The current course of disease (last onset) is at least 2 weeks; ⑤HAMD-17 score ≥17 points; ⑥ No electroconvulsive therapy was received in the first six months.
Who cannot join
- A combination of another mental illness; A history of alcohol/drug dependence or smoking > 10 cigarettes/day; ③ Serious physical diseases of the heart, liver, kidney, brain and hematopoietic system, central nervous system infection, head injury, epilepsy, multiple sclerosis, toxic metabolic diseases, Parkinson's disease or intracranial tumors; ④ Family history of hereditary diseases; ⑤Endocrine system diseases such as diabetes, hyperthyroidism or hypothyroidism; ⑥ Pregnant, lactating women or photosensitivities.
About this study
Official title: A Multicentre Clinical Study of Near Infrared Functional Brain Imaging Combined With Eye Tracking Technique for the Auxiliary Diagnosis and Treatment Effect Prediction of Depression
This study intends to conduct a multi-center, large-sample clinical trial, aiming at using multi-channel near-infrared spectroscopy to detect the characteristics of brain Oxy-Hb changes over time during cognitive activation in patients with depression before treatment and in the gender - and age-matched control group, and using eye tracking technology to detect the eye movement characteristics of patients with depression before treatment and in the gender - and age-matched control group. The sensitivity and specificity of fNIRS spectrum and eye movement index in objective diagnosis of patients with depressive disorder were calculated, and according to the HAMD reduction rate, depression patients after 2 weeks of treatment were divided into remission group and non-remission group. fNIRS imaging and eye movement indexes in depression group and normal control group were compared, fNIRS imaging and eye movement indexes in depression remission group before and after treatment, fNIRS imaging and eye movement indexes in depression remission group and non-remission group were compared at baseline to verify the biomarkers of fNIRS spectrum and eye movement indexes in predicting antidepressant efficacy. Finally, it provides reliable scientific evidence for the important role of fNIRS imaging and eye tracking technology in the diagnosis and treatment of depression.
- Conditions
- the Objective Diagnosis of Depression
- Being tested
- SSRIs, fNIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSRIsDrug
take SSRIs for 2 weeks
fNIRSDevice
All subjects receive fNIRS examination.
| Study group | Role | What they receive |
|---|---|---|
| depressive patients | Not described Receives: Drug: SSRIs; Device: fNIRS | |
| controls | Not described Receives: Device: fNIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
fNIRS
Sensitivity and specificity
Measured: 2024～2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Objective Diagnosis of 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
- Other
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonggui Yuan, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062666
- Sponsor's protocol ID
- MR-32-25-015243
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Clinical Study of Near Infrared Functional Brain Imaging Combined With Eye Tracking Technique for the Auxiliary Diagnosis and Treatment Effect Prediction of Depression
- ClinicalTrials.gov ID
- NCT07062666
- Acronym / sponsor ID
- MR-32-25-015243
- Conditions
- the Objective Diagnosis of Depression
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,250 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 14 Jul 2025 (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 intends to conduct a multi-center, large-sample clinical trial, aiming at using multi-channel near-infrared spectroscopy to detect the characteristics of brain Oxy-Hb changes over time during cognitive activation in patients with depression before treatment and in the gender - and age-matched control group, and using eye tracking technology to detect the eye movement characteristics of patients with depression before treatment and in the gender - and age-matched control group. The sensitivity and specificity of fNIRS spectrum and eye movement index in objective diagnosis of patients with depressive disorder were calculated, and according to the HAMD reduction rate, depression patients after 2 weeks of treatment were divided into remission group and non-remission group. fNIRS imaging and eye movement indexes in depression group and normal control group were compared, fNIRS imaging and eye movement indexes in depression remission group before and after treatment, fNIRS imaging and eye movement indexes in depression remission group and non-remission group were compared at baseline to verify the biomarkers of fNIRS spectrum and eye movement indexes in predicting antidepressant efficacy. Finally, it provides reliable scientific evidence for the important role of fNIRS imaging and eye tracking technology in the diagnosis and treatment of depression.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| depressive patients | – | Drug: SSRIs, Device: fNIRS |
| controls | – | Device: fNIRS |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- depressive patients
Key inclusion criteria (1 listed)
- Aged 18-60 years old; ② Right-handed; ③ Meet the DSM-5 diagnostic criteria for depression; ④ The current course of disease (last onset) is at least 2 weeks; ⑤HAMD-17 score ≥17 points; ⑥ No electroconvulsive therapy was received in the first six months.
Key exclusion criteria (1 listed)
- A combination of another mental illness; A history of alcohol/drug dependence or smoking > 10 cigarettes/day; ③ Serious physical diseases of the heart, liver, kidney, brain and hematopoietic system, central nervous system infection, head injury, epilepsy, multiple sclerosis, toxic metabolic diseases, Parkinson's disease or intracranial tumors; ④ Family history of hereditary diseases; ⑤Endocrine system diseases such as diabetes, hyperthyroidism or hypothyroidism; ⑥ Pregnant, lactating women or photosensitivities.
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 |
|---|---|---|
| SSRIstake SSRIs for 2 weeks | Drug | depressive patients |
| fNIRSAll subjects receive fNIRS examination. | Device | controls, depressive patients |
Primary outcome
fNIRS
Time frame: 2024～2025
Sensitivity and specificity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for the Objective Diagnosis of Depression
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of the Objective Diagnosis of Depression, run by Zhongda Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Jul 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
fNIRS (time frame: 2024～2025). 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 14 Jul 2025.