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A Multicentre Clinical Study

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07062666
Enrollment
2250
Registered
2025-07-14
Start date
2025-07-30
Completion date
2025-08-31
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

the Objective Diagnosis of Depression

Brief 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, 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.

Interventions

DRUGSSRIs

take SSRIs for 2 weeks

DEVICEfNIRS

All subjects receive fNIRS examination.

Sponsors

Zhongda Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
fNIRS2024~2025Sensitivity and specificity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026