Immune/Inflammatory Biomarkers in Postpartum Depression

Immune/Inflammatory Biomarkers in Postpartum Depression: Pathogenetic Mechanisms, MRI Endophenotypes, and Predictive Biomarkers

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05784116

Acronym

PPDINFLAME

Enrollment

300

Registered

2023-03-24

Start date

2022-04-01

Completion date

2024-11-24

Last updated

2023-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Postpartum

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactFrancesco Benedetti, MD

benedetti.francesco@hsr.it0039 02 26431

Backup ContactElisa MT Melloni, PhD

melloni.elisa@hsr.it

Outcome results