A Correlation Study of Cognitive Function in Patients With Depression

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05396989
• Other study ID #: JHW20220506
• Status: Not yet recruiting
• Start date: May 6, 2024
• Est. completion date: May 28, 2028

Study information

• Verified date: June 2023
• Source: Central South University
• Contact: Renrong H Wu, M.D. Ph.D
• Phone: +8615874149855
• Email: wurenrong[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 28, 2028
• Est. primary completion date: May 28, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Meets the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depressive disorders

2. Age 18-60 years, gender aside, at least 1 guardian to monitor the patient for 2 months

3. 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

4. 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

5. There is sufficient audiovisual level to complete the necessary examinations for the study

Exclusion Criteria:

1. Presence of any other medical disorder affecting reproductive endocrine function; Abusers of psychoactive substances or substances such as alcohol

2. People with severe physical disabilities who are unable to complete follow-up

3. 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

4. Previously or currently suffering from any major physical disease, neurological disorder, brain trauma, etc. that affect the structure or function of the brain

5. Suicidal or uncooperative

6. Pregnant or lactating women

7. There is significant anxiety, HAMA = 21 points

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Mental Health Institute of 2nd Xiangya Hospital,CSU	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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