NCT06100302

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

The First Affiliated Hospital of Xi'an Jiaotong University

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: —

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.

Detailed description

1. Participants were included according to the inclusion and exclusion criteria, and demographic data of depressed patients and healthy controls were recorded, including age, sex, ethnicity, occupation, etc. Subjects in the depression group were treated with antidepressants (as recommended by the guidelines) and were followed up baseline, 2 weeks, 8 weeks, 12 weeks, and 24 weeks after treatment, respectively. At each follow-up point, symptoms were assessed using Hamilton Depression Scale (HAMD), Hamilton Anxiety Scale (HAMA), Depression Screening Scale (PHQ-9) and Generalized Anxiety Scale (GAD-7), and cognitive function was assessed using Thinc-it at three follow-up points: baseline, 12 weeks after treatment, and 24 weeks after treatment. General data were compared between patients with depression and healthy controls at baseline. 2. The depression group was followed up. Serum and fecal of patients with depression were collected at 5 follow-up points at baseline, 2 weeks, 8 weeks, 12weeks and 24 weeks after treatment, and serum metabolic indexes and fecal metagenome were detected.

Conditions

• Depression

Interventions

Type	Name	Description
OTHER	no-intervention	no-intervention

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-07-01
• Completion: 2025-02-01
• First posted: 2023-10-25
• Last updated: 2023-10-25

Locations

1 site across 1 country: China