NCT06182722

Association of Peripheral Immune Cells With Antidepressant Treatment Response

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this observational study is discovering potential biomarkers to predict antidepressant treatment response in patients with major depressive disorder (MDD) while comparing the transcriptomic changes between patients with MDD and healthy controls as well as before and after antidepressant treatment. Eligible patients will be assessed at Week 1, Week 2, Week 4 and Week 8 while healthy normal volunteers will only be evaluated at baseline. Assessments will include the following: an interview about mental and physical health, a physical examination including drawing of venous blood samples and several psychiatric rating scales.

Detailed description

This study is focusing on evaluating the peripheral immune system of major depressive disorder (MDD) and the impact of antidepressants treatment. Single-cell RNA sequencing and single-cell VDJ sequencing will be performed on peripheral blood mononuclear cells to collect transcriptome information and immune repertoire of peripheral blood in patients with MDD. Bulk RNA sequencing and flow cytometry will be used to validate the clinical value of results. This is a biomarker study (antidepressants); treatment will be carried out according to physicians' orders.

Conditions

• Depressive Disorder
• Genetic Change

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Mental assessments	Patients will receive psychiatric rating scales evaluation every visit.

Timeline

• Start date: 2024-03-13
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-12-27
• Last updated: 2024-04-09

Locations

1 site across 1 country: China