Perinatal DepressionPRESeNTNCT05951738
Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies
A study testing Blood and saliva collection, Psychometric scales and Smartphone app in people with Perinatal Depression, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 4 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Blood and saliva collection, Psychometric scales and Smartphone app
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesItaly
- Study dates
- 11 Feb 2022to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women of a singleton pregnancy
- Age ≥ 18 years
Who cannot join
- Uterine anomalies and obstetric complications
- Comorbidity with severe or chronic diseases
- Substance abuse
- Language barrier
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 3 recruiting
- Active, not recruiting
IRCCS Centro San Giovanni di Dio Fatebenefratelli
Brescia, 25125
- Not yet recruiting
Centro Psiche Donna - Ospedale Macedonio Melloni - ASST Fatebenefratelli Sacco
Milan
Roberta Anniverno
- Not yet recruiting
Ospedale San Raffaele
Milan
Francesco Benedetti
- Recruiting
ASST Bergamo ovest
Treviglio
Marina Cattaneo
About this study
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.
The study aims at identifying:
- specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
- 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;
- 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;
Read more
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.
- Conditions
- Perinatal Depression
- Being tested
- Blood and saliva collection, Psychometric scales, Smartphone app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and saliva collectionProcedure or surgery
Blood and saliva samples from pregnant women; saliva samples from babies.
Psychometric scalesBehavioural
A battery of psychometric scales and questionnaires.
Smartphone appOther
A smartphone application has been developed in the context of the study as a potential preventive and screening strategy.
| Study group | Role | What they receive |
|---|---|---|
| Depressed | Other | Not described Receives: Procedure: Blood and saliva collection; Behavioral: Psychometric scales; Other: Smartphone app |
| At high risk | Other | Not described Receives: Procedure: Blood and saliva collection; Behavioral: Psychometric scales; Other: Smartphone app |
| Control | Other | Not described Receives: Procedure: Blood and saliva collection; Behavioral: Psychometric scales; Other: Smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentially expressed genes and biological pathways modulation
Measured: 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
Measured: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Cortisol levels
Measured: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Immune-related factors levels
Measured: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Smartphone app utility
Measured: From 25th of gestation to 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start11 Feb 2022
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro San Giovanni di Dio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annamaria Cattaneo, IRCCS Centro San Giovanni di Dio Fatebenefratelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951738
- Sponsor's protocol ID
- PRESeNT
- Other IDs
- 1749118
- Acronym
- PRESeNT
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05951738
- Acronym / sponsor ID
- PRESeNT / PRESeNT
- Conditions
- Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- IRCCS Centro San Giovanni di Dio FatebenefratelliUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims at identifying:
- specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
- 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;
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depressed | Other | Procedure: Blood and saliva collection, Behavioral: Psychometric scales, Other: Smartphone app |
| At high risk | Other | Procedure: Blood and saliva collection, Behavioral: Psychometric scales, Other: Smartphone app |
| Control | Other | Procedure: Blood and saliva collection, Behavioral: Psychometric scales, Other: Smartphone app |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women of a singleton pregnancy
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Uterine anomalies and obstetric complications
- Comorbidity with severe or chronic diseases
- Substance abuse
- Language barrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and saliva collectionBlood and saliva samples from pregnant women; saliva samples from babies. | Procedure or surgery | At high risk, Control, Depressed |
| Psychometric scalesA battery of psychometric scales and questionnaires. | Behavioural | At high risk, Control, Depressed |
| Smartphone appA smartphone application has been developed in the context of the study as a potential preventive and screening strategy. | Other | At high risk, Control, Depressed |
Primary outcome
Differentially expressed genes and biological pathways modulation
Time frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
4 secondary outcomes
Rate and profile of DNA methylation
Time frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Cortisol levels
Time frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Immune-related factors levels
Time frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.
Smartphone app utility
Time frame: From 25th of gestation to 12 months postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and saliva collection, Psychometric scales and Smartphone app in people with Perinatal Depression, run by IRCCS Centro San Giovanni di Dio Fatebenefratelli at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annamaria Cattaneo (+390303501361, acattaneo@fatebenefratelli.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentially expressed genes and biological pathways modulation (time frame: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.