NCT05784116

Immune/Inflammatory Biomarkers in Postpartum Depression

Immune/Inflammatory Biomarkers in Postpartum Depression: Pathogenetic Mechanisms, MRI Endophenotypes, and Predictive Biomarkers

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This will be a very straightforward study assessing changes of immune/inflammatory peripheral biomarkers before/after delivery with postpartum mood and the psychopathological features of postpartum depression (PPD), and with MRI measures of functional and structural brain integrity. Multimodal assessment of peripheral cytokines, PBMC gene expression, FACS immunophenotyping, and IDO activation, will be validated with (a) clinical data about the presentation of PPD, (b) self- and observer ratings of psychopatology, (c) results coming from neuropsychological assessment of cognitive functions, and (d) multimodal brain imaging outcomes (WM integrity, functional connectivity, GM volumes). It is expected that worsening or stabilization of mood, and the diagnosis of PPD, will be paralleled by worsening or stabilization of these measures, thus providing new markers to estimate the susceptibility to the disorder, to identify targets for treatment, and to predict and monitor treatment efficacy.

Conditions

• Depression, Postpartum

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-11-24
• Completion: 2024-11-24
• First posted: 2023-03-24
• Last updated: 2023-03-24

Locations

1 site across 1 country: Italy