Immune/Inflammatory Biomarkers in Postpartum Depression

Recruiting

• Conditions: Depression, Postpartum

• Registration Number: NCT05784116
• Lead Sponsor: IRCCS San Raffaele

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-24
• Last Update Posted: 2023-03-24
• Primary Completion: 2024-11-24
• Study Completion: 2024-11-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral inflammation	9 months	peripheral markers of immune/inflammatory activation before/after delivery predicting pre- and post-partum depressive psychopathology
Postpartum depression	9 months	condition of PPD in the six months following delivery

Secondary Outcome Measures

Name	Time	Method
Multimodal MRI	9 months	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

Trial Locations

Locations (1)

Ospedale San Raffaele; 🇮🇹 Milano, Italy