Immune/Inflammatory Biomarkers in Postpartum Depression (PPDINFLAME)

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.

Study Overview

• Status: Recruiting
• Conditions: Depression, Postpartum

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Francesco Benedetti, MD; Phone Number: 0039 02 26431; Email: benedetti.francesco@hsr.it
• Study Contact Backup: Name: Elisa MT Melloni, PhD; Email: melloni.elisa@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele
    • Contact: Francesco Benedetti, MD; Phone Number: 0039 02 26431; Email: benedetti.francesco@hsr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

-Signed informed consent, able to understand, speak and write the national language

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Collaborators: Ministry of Health, Italy
• Investigators: Principal Investigator: Francesco Benedetti, MD, IRCCS Ospedale San Raffaele, Milano

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): November 24, 2024
• Study Completion (Anticipated): November 24, 2024

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: RF-2019-12371066

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No