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| Name | Class |
|---|---|
| Ministry of Health, Italy | OTHER_GOV |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Peripheral inflammation | peripheral markers of immune/inflammatory activation before/after delivery predicting pre- and post-partum depressive psychopathology | 9 months |
| Postpartum depression | condition of PPD in the six months following delivery | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 months |
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Inclusion Criteria:
-Signed informed consent, able to understand, speak and write the national language
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Benedetti, MD | Contact | 0039 02 26431 | benedetti.francesco@hsr.it | |
| Elisa MT Melloni, PhD | Contact | melloni.elisa@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Benedetti, MD | IRCCS Ospedale San Raffaele, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Plasma, Serum, Peripheral whole blood for gene expression, PBMC cells
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |