Immune/Inflammatory Biomarkers in Postpartum Depression

NCT ID: NCT05784116

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-11-24

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Italy

OTHER_GOV

Sponsor Role: collaborator

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Francesco Benedetti

Group Leader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesco Benedetti, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele, Milano

Locations

Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Benedetti, MD

Role: CONTACT

benedetti.francesco@hsr.it

0039 02 26431

Elisa MT Melloni, PhD

Role: CONTACT

melloni.elisa@hsr.it

Facility Contacts

Francesco Benedetti, MD

Role: primary

benedetti.francesco@hsr.it

0039 02 26431

Other Identifiers

RF-2019-12371066

Identifier Type: -

Identifier Source: org_study_id