NCT07062666

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
• Phase: —
• Study type: Observational
• Enrollment: 2,250 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• the Objective Diagnosis of Depression

Interventions

Type	Name	Description
DRUG	SSRIs	take SSRIs for 2 weeks
DEVICE	fNIRS	All subjects receive fNIRS examination.

Timeline

• Start date: 2025-07-30
• Primary completion: 2025-08-01
• Completion: 2025-08-31
• First posted: 2025-07-14
• Last updated: 2025-07-14

Regulatory

• FDA-regulated drug study
• FDA-regulated device study