Immune/Inflammatory Biomarkers in Postpartum Depression

Depression, Postpartum Clinical Trial

— PPDINFLAME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784116
• Other study ID #: RF-2019-12371066
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: November 24, 2024

Study information

• Verified date: March 2023
• Source: IRCCS San Raffaele
• Contact: Francesco Benedetti, MD
• Phone: 0039 02 26431
• Email: benedetti.francesco[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 24, 2024
• Est. primary completion date: November 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral inflammation	peripheral markers of immune/inflammatory activation before/after delivery predicting pre- and post-partum depressive psychopathology	9 months
Primary	Postpartum depression	condition of PPD in the six months following delivery	9 months
Secondary	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