跳至主要内容
临床试验/NCT07062666
NCT07062666尚未招募不适用

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

Zhongda Hospital0 个研究点目标入组 2,250 人开始时间: 2025年7月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,250
主要终点
fNIRS

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

depressive patients

干预措施: SSRIs (Drug)

depressive patients

干预措施: fNIRS (Device)

controls

干预措施: fNIRS (Device)

结局指标

主要结局

fNIRS

时间窗: 2024~2025

Sensitivity and specificity

次要结局

未报告次要终点

研究者

发起方
Zhongda Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yonggui Yuan

Chairman of Scientific Committee

Zhongda Hospital

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