Immune/Inflammatory Biomarkers in Postpartum Depression

NCT05784116 | Unknown DMC

• 1 other identifier: RF-2019-12371066
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Multimodal MRI

  9 months

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, Peripheral whole blood for gene expression, PBMC cells

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Francesco Benedetti, MD

  IRCCS Ospedale San Raffaele, Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Benedetti, MD

CONTACT

0039 02 26431; benedetti.francesco@hsr.it

Elisa MT Melloni, PhD

CONTACT

melloni.elisa@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Group Leader

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: April 1, 2022
• Primary Completion: November 24, 2024
• Study Completion: November 24, 2024
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

IT (1)