Study on the Mechanism of Immune Inflammation in Cognitive Impairment of Depression

NCT06100302 | Unknown

• 1 other identifier: XJTU1AF2022LSK-249
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The patients with depression were observed and followed up to evaluate the changes of symptoms and cognitive function in patients with depression at different time points before and after drug treatment. At the same time, immunometabolism indicators in serum, urine and stool were detected to screen out immunoinflammatory markers related to cognitive function and treatment response in patients with depression, hoping to provide a new strategy for optimal treatment of depression.

Conditions

Depression

Keywords

depression; Immune metabolism; Cognitive function

Outcome Measures

Primary Outcomes (4)

• Scores of Hamilton Depression Scale

  Using to assess depressive symptoms. With higher scores associated with more severe depression symptoms. Total scores \<7 is normal; Mild depression with total scores of 7～17; Moderate depression with total scores of 18～24; Total scores \>24 for severe depression.

  baseline、2weeks、8weeks、12weeks、24weeks

• Scores of Hamilton Anxiety Scale

  Using to assess anxiety symptoms. With higher scores associated with more severe anxiety symptoms. Total scores\< 7 indicates no anxiety; Total scores≥7 indicates possible anxiety; Total scores≥14 indicates anxiety; Total scores≥21 indicates obvious anxiety; Total scores≥29 points indicates serious anxiety.

  baseline、2weeks、8weeks、12weeks、24weeks

• Patient Health Questionnaire-9

  Using to assess depression symptoms, scores range from 0～27, With higher scores associated with more severe depression symptoms. Total scores 0～4 indicates no depression; Total scores 5～9 indicates mild depression; Total scores 10～14 indicates moderate depression; Total scores 15～19 indicate moderate to severe depression; Total scores 20～27 indicates major depression.

  baseline、2weeks、8weeks、12weeks、24weeks

• Generalized self-rating anxiety Scale

  Using to assess anxiety symptoms, scores range from 0～21. With higher scores associated with more severe anxiety symptoms. Total scores 5～9 indicates mild anxiety; Total scores 10～14 scores indicate moderate anxiety; Total scores 15～21 scores indicate severe anxiety.

  baseline、2weeks、8weeks、12weeks、24weeks

Secondary Outcomes (4)

• Thinc-it cognitive function test

  basline、12weeks、24weeks

• Sheehan Disability Scale

  basline、12weeks、24weeks

• Pittsburgh Sleep Quality Index

  baseline、2weeks、8weeks、12weeks、24weeks

• Gastrointestinal function scale

  baseline、2weeks、8weeks、12weeks、24weeks

Other Outcomes (2)

• Serum metabolites

  baseline、2weeks、8weeks、12weeks、24weeks

• Shotgun Metagenomic Sequencing and Metagenome-Wide Intestinal macrogene

  baseline、2weeks、8weeks、12weeks、24weeks

Study Arms (2)

MD group

Patients with depression who met the inclusion criteria

Other: no-intervention

HC group

Healthy subjects meeting enrollment criteria

Other: no-intervention

Interventions

no-intervention OTHER

no-intervention

HC group; MD group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Meet the diagnostic criteria for depression in the International Classification of Diseases-10 (ICD-10), and the Hamilton Depression Scale (HAMD) score ≥18 points

You may qualify if:

• Age 18-60 years old, male or female;
• Meet the diagnostic criteria for depression in the International Classification of Diseases-10 (ICD-10), and the Hamilton Depression Scale (HAMD) score ≥18 points;
• Junior high school education and above, can cooperate with the completion of relevant scales and sample collection;
• did not receive antidepressant therapy at admission or took medication for less than 14 days; And the duration of drug withdrawal ≥3 months;
• No history of infection and taking hormones, antibiotics or anti-inflammatory drugs in the past 1 month;
• History of physical diseases such as centerless, liver, kidney and gastrointestinal tract, active infection, active or chronic inflammation, autoimmune diseases, etc.

You may not qualify if:

• Pregnant and lactating women;
• Clinically significant or unstable medical conditions, including congestive heart failure, liver and kidney failure, cancer, immune and metabolic endocrine diseases;
• Patients with acute or chronic infection, taking anti-inflammatory drugs, cortisol hormones, and receiving antibiotics for 3 consecutive days in the past 1 month;
• Patients with neuropsychiatric diseases other than depression.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

277 Yanta West Road

Xi'an, Yanta, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Ma x c

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Jia M

CONTACT

02985324575; tsooung@163.com

Ma q y

CONTACT

02985324575; mqy910413@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2023
• First Posted: October 25, 2023
• Study Start: July 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: February 1, 2025
• Last Updated: October 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)