A Correlation Study of Cognitive Function in Patients With Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Near-infrared, Eye Movement and Depressive Symptoms in Patients With Depression Correlation Study of Cognitive Function: a Prospective Observational Cohort Study

Conditions
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Depression

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| First-onset of depressed patients<br>first attack | Other: No intervention<br>* No intervention<br>|
| Patients with recurrent depression<br>relapse | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Depression Scale (HAMD-17) | Scores ranging from 0-54, with higher scores indicating more severe symptoms | Baseline, the first month, the second month and the third month | 
| Change in Pittsburgh Sleep Quality Scale (PSQI) | Scores ranging from 0-21, with higher scores indicating more severe symptoms | Baseline, the first month, the second month and the third month | 
| Changes in Beck Suicidal Scale Inventory (BSI) | Scores ranging from 0-100, with higher scores indicating more severe symptoms | Baseline, the first month, the second month and the third month | 
| Changes in selective attention through eye-tracking task. | 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. | Baseline, the first month, the second month and the third month | 
| Changes in cerebral blood flow of left DLPFC through Near Infrared Spectroscopy (fNIRS) | Measuring the hemoglobin concentration of cerebral cortex during verbal fluency test and emotion recognition test. | Baseline, the first month, the second month and the third month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hamilton Anxiety Scale (HAMA) | Scores ranging from 0-56, with higher scores indicating more severe symptoms | Baseline, the first month, the second month and the third month | 
| Change in Young's Mania Scale (YMRS) | Scores ranging from 0-60, with higher scores indicating more severe symptoms | Baseline, the first month, the second month and the third month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, cognition function, Near-infrared, Eye movement