Depression, PostpartumPPDINFLAMENCT05784116
Immune/Inflammatory Biomarkers in Postpartum Depression
An observational study of Depression, Postpartum, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Postpartum
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2022to 24 Nov 2024
- Phase
- Observational
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 150 pregnant women will be recruited in each center. We expect 15-30 women per group to develop PPD and be matched with HC in a 1:2 ratio, yielding a sample of 30-60 PPD patients and 60-120 HC. Patients will be recruited at the Department of Obstetrics and Ginecology of Ospedale San Raffaele and at the Department of Woman, Children and Newborn (Clinica Mangiagalli), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. Patients will be recruited at the 20th week of gestation when patients fulfilling the inclusion criteria will be offered the possibility to participate to the study.
Who may be able to join
- -Signed informed consent, able to understand, speak and write the national language
Who cannot join
- History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis NOS; anorexia or bulimia nervosa;
- Taking following medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants
- Active infection requiring antibiotics therapy;
- Immunosuppressed patient
- Other chronic diseases
- Signs of active infection requiring treatment
Show all 12Show fewer
- Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder. - - Forbidden treatment: corticosteroids, NSAD, immunosuppressant IV-Ig based treatment
- Ongoing fever, infection treated by antibiotics or uncontrolled diabetes type I or II;
- Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer);
- Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere e with the conduct of the trial;
- Abuse of drugs or alcohol in the past 6 months
- Presence of chromosomal disorders
Trial locations and contacts
1 site in 1 country.
Elisa MT Melloni, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele
Milan, 20132
Francesco Benedetti, MD, 0039 02 26431, benedetti.francesco@hsr.it
About this study
Official title: Immune/Inflammatory Biomarkers in Postpartum Depression: Pathogenetic Mechanisms, MRI Endophenotypes, and Predictive Biomarkers
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
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral inflammation
peripheral markers of immune/inflammatory activation before/after delivery predicting pre- and post-partum depressive psychopathology
Measured: 9 months
Postpartum depression
condition of PPD in the six months following delivery
Measured: 9 months
Secondary outcomes (1)
Multimodal MRI
To correlate peripheral markers of immune/inflammatory activation with multimodal MRI measures of WM and GM integrity, functional connectivity, 1H-MRS spectroscopy, and with measures of cognitive functions in PPD
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Apr 2022
- Primary completion24 Nov 2024 (estimated)
- Study completion24 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Principal investigator, Francesco Benedetti, IRCCS San Raffaele
- Investigators
- Francesco Benedetti, MD, Principal investigator, IRCCS Ospedale San Raffaele, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784116
- Sponsor's protocol ID
- RF-2019-12371066
- Acronym
- PPDINFLAME
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune/Inflammatory Biomarkers in Postpartum Depression: Pathogenetic Mechanisms, MRI Endophenotypes, and Predictive Biomarkers
- ClinicalTrials.gov ID
- NCT05784116
- Acronym / sponsor ID
- PPDINFLAME / RF-2019-12371066
- Conditions
- Depression, Postpartum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 24 Nov 2024 (estimated)
- Study completion
- 24 Nov 2024 (estimated)
- First posted
- 24 Mar 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 150 pregnant women will be recruited in each center. We expect 15-30 women per group to develop PPD and be matched with HC in a 1:2 ratio, yielding a sample of 30-60 PPD patients and 60-120 HC. Patients will be recruited at the Department of Obstetrics and Ginecology of Ospedale San Raffaele and at the Department of Woman, Children and Newborn (Clinica Mangiagalli), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico. Patients will be recruited at the 20th week of gestation when patients fulfilling the inclusion criteria will be offered the possibility to participate to the study.
Key inclusion criteria (1 listed)
- -Signed informed consent, able to understand, speak and write the national language
Key exclusion criteria (12 listed)
- History of bipolar disorder, schizophrenia, schizoaffective disorder, psychosis NOS; anorexia or bulimia nervosa;
- Taking following medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants
- Active infection requiring antibiotics therapy;
- Immunosuppressed patient
- Other chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral inflammation
Time frame: 9 months
peripheral markers of immune/inflammatory activation before/after delivery predicting pre- and post-partum depressive psychopathology
Postpartum depression
Time frame: 9 months
condition of PPD in the six months following delivery
1 secondary outcome
Multimodal MRI
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
Elisa MT Melloni, PhD contact
Francesco Benedetti, MD principal investigator
IRCCS Ospedale San Raffaele, Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Postpartum, run by IRCCS San Raffaele at 1 site 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 1 inclusion and 12 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 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Francesco Benedetti, MD (0039 02 26431, benedetti.francesco@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral inflammation (time frame: 9 months). The study lists 2 primary outcomes in all. 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 24 Mar 2023.