Last reviewed · How we verify
NCT05784116: PPDINFLAME
Immune/Inflammatory Biomarkers in Postpartum Depression
trial in Depression, Postpartum in 300 participants. Status unknown.
24 November 2024
Quick facts
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 April 2022 |
| Primary completion | 24 November 2024 |
| Estimated completion | 24 November 2024 |
| Sites | 1 location across Italy |
Conditions studied
- Depression, Postpartum — all drugs for Depression, Postpartum →
Sponsor
IRCCS San Raffaele — full company profile →
Who can join
Adults 18 to 45, female only, with Depression, Postpartum. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05784116
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Depression, Postpartum
Currently open trials in the same condition.
- NCT07047820 — A Study to Learn More About How Zuranolone Affects Postpartum Depression Symptoms in Participants Who Took it Within 1 Y · recruiting
- NCT06746337 — IMAGINE: Pilot Trial of a Digital Group Intervention to Prevent Perinatal Depression · NA · recruiting
- NCT06364488 — TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety · NA · recruiting
- NCT06772701 — Validation of the French Version of the Edinburgh Postnatal Depression Scale (EPDS) Postnatally in the Father · NA · recruiting
- NCT06469476 — Evaluation of Access to Screening for Post-partum Depression Via the Postnatal Interview Within 8 Weeks of Birth in Wome · recruiting
Other IRCCS San Raffaele trials
Trials by the same sponsor.
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- NCT07526298 — Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Ap · not yet recruiting
- NCT07426471 — Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections. · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05784116 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS San Raffaele
- Last refreshed: 24 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05784116.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing