Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies — PRESeNT  

Perinatal Depression Clinical Trial

Official title: Exposures to PRenatal and Postnatal Adverse Stressful Experiences: Multimodal Omics Signatures Underlying Stress Vulnerability and Resilience and as Novel Targets for Preventive Strategies.

Status Recruiting

Clinical Trial Summary

The study aims at identifying:

1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.

2. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk;

3. whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women;

In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum.

Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health.

Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses.

Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses.

Clinical and psychological data will be collected from women at all timepoints.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Depression
• Perinatal Depression

• NCT number: NCT05951738
• Study type: Interventional
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Contact: Annamaria Cattaneo
• Phone: +390303501361
• Email: acattaneo@fatebenefratelli.eu
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2022
• Completion date: July 2025