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

Perinatal Depression Clinical Trial

— PRESeNT  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05951738
• Other study ID #: PRESeNT
• Secondary ID: 1749118
• Status: Recruiting
• Phase: N/A
• Start date: February 11, 2022
• Est. completion date: July 2025

Study information

• Verified date: July 2023
• Source: IRCCS Centro San Giovanni di Dio Fatebenefratelli
• Contact: Annamaria Cattaneo
• Phone: +390303501361
• Email: acattaneo[@]fatebenefratelli.eu
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women of a singleton pregnancy

• Age = 18 years

Exclusion Criteria:

• Uterine anomalies and obstetric complications

• Comorbidity with severe or chronic diseases

• Substance abuse

• Language barrier

Related Conditions & MeSH terms

• Depression
• Perinatal Depression

Intervention

Procedure:
• Blood and saliva collection
Blood and saliva samples from pregnant women; saliva samples from babies.

Behavioral:
• Psychometric scales
A battery of psychometric scales and questionnaires.

Other:
• Smartphone app
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.

Locations

Country	Name	City	State
Italy	IRCCS Centro San Giovanni di Dio Fatebenefratelli	Brescia
Italy	Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco	Milano
Italy	Ospedale San Raffaele	Milano
Italy	ASST Bergamo ovest	Treviglio

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro San Giovanni di Dio Fatebenefratelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differentially expressed genes and biological pathways modulation		25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Secondary	Rate and profile of DNA methylation		25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Secondary	Cortisol levels		25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Secondary	Immune-related factors levels		25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Secondary	Smartphone app utility		From 25th of gestation to 12 months postpartum