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NCT Number: NCT05396989

A Correlation Study of Cognitive Function in Patients With Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Change in Hamilton Depression Scale (HAMD-17)

    Time frame: Baseline, the first month, the second month and the third month

    Scores ranging from 0-54, with higher scores indicating more severe symptoms

  2. Change in Pittsburgh Sleep Quality Scale (PSQI)

    Time frame: Baseline, the first month, the second month and the third month

    Scores ranging from 0-21, with higher scores indicating more severe symptoms

  3. Changes in Beck Suicidal Scale Inventory (BSI)

    Time frame: Baseline, the first month, the second month and the third month

    Scores ranging from 0-100, with higher scores indicating more severe symptoms

  4. Changes in selective attention through eye-tracking task.

    Time frame: 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.

  5. Changes in cerebral blood flow of left DLPFC through Near Infrared Spectroscopy (fNIRS)

    Time frame: 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.

Secondary outcomes

  1. Change in Hamilton Anxiety Scale (HAMA)

    Time frame: Baseline, the first month, the second month and the third month

    Scores ranging from 0-56, with higher scores indicating more severe symptoms

  2. Change in Young's Mania Scale (YMRS)

    Time frame: Baseline, the first month, the second month and the third month

    Scores ranging from 0-60, with higher scores indicating more severe symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Huang, Ph.D

CONTACT

[email protected]

+8615874290980

Renrong H Wu, M.D. Ph.D

CONTACT

[email protected]

+8615874149855

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 31, 2022
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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