Near-infrared, Eye Movement and Depressive Symptoms in Patients With Depression Correlation Study of Cognitive Function: a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in Beck Suicidal Scale Inventory (BSI)
研究概览
简要总结
Many studies have shown that patients with depression had weak brain region connections and low levels of activation of the prefrontal lobe when brain activity was active and that patients with depression have a negative attentional bias, and the patient's abnormal attentional allocation may stem from a loss of attention avoidance of negative cues and a loss of attention preference for positive cues. Here use the near-infrared, eye movement to evaluate the cognitive function in patients with depression. The purpose of the study is to explore the correlation between depressed symptom and cognition function among the depression patients and the difference between first-onset of depressed patients and those is recurrent.
详细描述
This study will comprise 200 patients with depression disorder. All participants will be assessed and clinically examined at baseline, and all patients are encouraged to follow up at week 12. Baseline assessments will include demographics, menstrual records for female, comprehensive medical history, physical examination, near-infrared, eye movement and laboratory work (e.g., hormones). The follow-up of patients will include laboratory work, near-infrared, eye movement. Clinical symptoms will be assessed by HAMD-17,HamiltonAnxietyScale, and Young Mania Rating Scale. The cognitive function will be assessed at baseline and week 12 .The primary outcomes will be the near-infrared , eye movement . Secondary outcomes will include overall psychiatric symptomatology, cognitive function, and other biological data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depressive disorders
- •Age 18-60 years, gender aside, at least 1 guardian to monitor the patient for 2 months
- •Obtain informed consent from patients and guardians, sign informed consent forms, and be able to comply with planned visits, laboratory tests, and other research procedures
- •It is expected that there will be no problems such as relocation of residence, inconvenience of transportation, and difficulty in obtaining medical treatment throughout the study process
- •There is sufficient audiovisual level to complete the necessary examinations for the study
排除标准
- •Presence of any other medical disorder affecting reproductive endocrine function; Abusers of psychoactive substances or substances such as alcohol
- •People with severe physical disabilities who are unable to complete follow-up
- •Have been diagnosed or have had other severe psychiatric disorders that meet the diagnostic criteria for DSM-5, mental retardation, dementia, severe cognitive dysfunction, etc
- •Previously or currently suffering from any major physical disease, neurological disorder, brain trauma, etc. that affect the structure or function of the brain
- •Suicidal or uncooperative
- •Pregnant or lactating women
- •There is significant anxiety, HAMA ≥ 21 points
结局指标
主要结局
Changes in Beck Suicidal Scale Inventory (BSI)
时间窗: Baseline, the first month, the second month and the third month
Scores ranging from 0-100, with higher scores indicating more severe symptoms
Changes in selective attention through eye-tracking task.
时间窗: Baseline, the first month, the second month and the third month
Eye-tracking task was performed using the free-viewing paradigm. By presenting images of irritable, threatening,positive, and neutral emotional scenes, the subject's selective attention was measured.
Change in Hamilton Depression Scale (HAMD-17)
时间窗: Baseline, the first month, the second month and the third month
Scores ranging from 0-54, with higher scores indicating more severe symptoms
Change in Pittsburgh Sleep Quality Scale (PSQI)
时间窗: Baseline, the first month, the second month and the third month
Scores ranging from 0-21, with higher scores indicating more severe symptoms
Changes in cerebral blood flow of left DLPFC through Near Infrared Spectroscopy (fNIRS)
时间窗: Baseline, the first month, the second month and the third month
Measuring the hemoglobin concentration of cerebral cortex during verbal fluency test and emotion recognition test.
次要结局
- Change in Young's Mania Scale (YMRS)(Baseline, the first month, the second month and the third month)
- Change in Hamilton Anxiety Scale (HAMA)(Baseline, the first month, the second month and the third month)
研究者
Renrong Wu
Professor
Central South University