NCT05951738

Brief Summary

The study aims at identifying:

  1. 1.specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
  2. 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. 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;

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3.4 years

First QC Date

July 3, 2023

Last Update Submit

July 10, 2023

Conditions

Perinatal Depression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Rate and profile of DNA methylation

    25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.

  • Cortisol levels

    25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.

  • Immune-related factors levels

    25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.

  • Smartphone app utility

    From 25th of gestation to 12 months postpartum

Study Arms (3)

Depressed

OTHER
Procedure: Blood and saliva collectionBehavioral: Psychometric scalesOther: Smartphone app

At high risk

OTHER
Procedure: Blood and saliva collectionBehavioral: Psychometric scalesOther: Smartphone app

Control

OTHER
Procedure: Blood and saliva collectionBehavioral: Psychometric scalesOther: Smartphone app

Interventions

Blood and saliva collectionPROCEDURE

Blood and saliva samples from pregnant women; saliva samples from babies.

At high riskControlDepressed
Psychometric scalesBEHAVIORAL

A battery of psychometric scales and questionnaires.

At high riskControlDepressed
Smartphone appOTHER

A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.

At high riskControlDepressed

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women of a singleton pregnancy
  • Age ≥ 18 years

You may not qualify if:

  • Uterine anomalies and obstetric complications
  • Comorbidity with severe or chronic diseases
  • Substance abuse
  • Language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Brescia, 25125, Italy

ACTIVE NOT RECRUITING

Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco

Milan, Italy

NOT YET RECRUITING

Ospedale San Raffaele

Milan, Italy

NOT YET RECRUITING

ASST Bergamo ovest

Treviglio, Italy

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Annamaria Cattaneo

CONTACT

+390303501361acattaneo@fatebenefratelli.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Biological Psichiatry unit

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 19, 2023

Study Start

February 11, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 19, 2023

Record last verified: 2023-07

Locations

IT(4)