A Correlation Study of Cognitive Function in Patients With Depression

NCT05396989 | Not Yet Recruiting

• 1 other identifier: JHW20220506
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Depression; cognition function; Near-infrared; Eye movement

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Change in Hamilton Anxiety Scale (HAMA)

  Baseline, the first month, the second month and the third month

• Change in Young's Mania Scale (YMRS)

  Baseline, the first month, the second month and the third month

Study Arms (2)

First-onset of depressed patients

first attack

Other: No intervention

Patients with recurrent depression

relapse

Other: No intervention

Interventions

No intervention OTHER

No intervention

First-onset of depressed patients; Patients with recurrent depression

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

First-onset of depressed patients and patients with recurrent depression

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Mental Health Institute of 2nd Xiangya Hospital,CSU

Changsha, Hunan, 410001, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample and fecal sample

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Renrong H Wu, M.D. Ph.D

CONTACT

+8615874149855; wurenrong@csu.edu.cn

Jing Huang, Ph.D

CONTACT

+8615874290980; jinghuangserena001@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 31, 2022
• Study Start: May 6, 2024
• Primary Completion (Estimated): May 28, 2028
• Study Completion (Estimated): May 28, 2028
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)