A Multicentre Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-30

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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the Objective Diagnosis of Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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depressive patients

SSRIs

Intervention Type DRUG

take SSRIs for 2 weeks

fNIRS

Intervention Type DEVICE

All subjects receive fNIRS examination.

controls

fNIRS

Intervention Type DEVICE

All subjects receive fNIRS examination.

Interventions

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SSRIs

take SSRIs for 2 weeks

Intervention Type DRUG

fNIRS

All subjects receive fNIRS examination.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes