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A Correlation Study of Cognitive Function in Patients With Depression

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ClinicalTrials.gov Identifier: NCT05396989
Recruitment Status : Not yet recruiting
First Posted : May 31, 2022
Last Update Posted : July 3, 2023
Sponsor:
Information provided by (Responsible Party):
Renrong Wu, Central South University

Study Description
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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.

Condition or disease Intervention/treatment
Depression Other: No intervention

Detailed 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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Near-infrared, Eye Movement and Depressive Symptoms in Patients With Depression Correlation Study of Cognitive Function: a Prospective Observational Cohort Study
Estimated Study Start Date : May 6, 2024
Estimated Primary Completion Date : May 28, 2028
Estimated Study Completion Date : May 28, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
First-onset of depressed patients
first attack
 Other: No intervention
No intervention
Patients with recurrent depression
relapse
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
blood sample and fecal sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
First-onset of depressed patients and patients with recurrent depression
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05396989


Contacts
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Contact: Renrong H Wu, M.D. Ph.D +8615874149855 wurenrong@csu.edu.cn
Contact: Jing Huang, Ph.D +8615874290980 jinghuangserena001@csu.edu.cn

Locations
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China, Hunan
Mental Health Institute of 2nd Xiangya Hospital,CSU
Changsha, Hunan, China, 410001
Contact: Renrong Wu, M.D. Ph.D    +8615874149855    wurenrong@csu.edu.cn   
Contact: Jing Huang, M.D. Ph.D    +8615874290980    jinghuangserena001@csu.edu.cn   
Sponsors and Collaborators
Central South University
More Information
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Responsible Party: Renrong Wu, Professor, Central South University
ClinicalTrials.gov Identifier: NCT05396989    
Other Study ID Numbers: JHW20220506
First Posted: May 31, 2022    Key Record Dates
Last Update Posted: July 3, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Renrong Wu, Central South University:
Depression
cognition function
Near-infrared
Eye movement
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders