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PANDA-study - Prenatal And Neonatal Development: An offspring study of severe mental illness

PANDA-study - Prenatal And Neonatal Development: An offspring study of severe mental illness - PANDA-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56412
Enrollment
145
Registered
2023-04-19
Start date
2023-11-03
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

psychotic disorder

Interventions

Venapunction and MRI

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
No minimum to 64 Years

Inclusion criteria

Inclusion criteria: All pregnant women and their partners: • At least 18 years old • Ability to provide informed consent • Singleton pregnancy • Biological parent of the fetus/neonate Pregnant women and their partners with at least one (future) parent with SMI: • At least one (future) parent with SMI in the mood-psychosis spectrum diagnosed before current pregnancy, i.e., schizophrenia, bipolar disorder, severe MDD (i.e., with high recurrence rate and/or hospitalizations), psychosis NOS, single psychosis

Exclusion criteria

Exclusion criteria: All pregnant women: • Contraindication for MRI (including claustrophobia, a cardiac implantable  electronic device, ferromagnetic metal implants, piercing (in some cases),  tattoos (in some cases)) (Ghadimi & Sapra, 2022). • Postpartum psychosis (after a prior pregnancy) • Not willing to be informed about incidental findings following MRI assessment All pregnant women and their partners: • Substance use disorder (alcohol, drugs), active < six months pre pregnancy as  assessed with R4U or current addiction treatment such as methadone or  buprenorphine • Not willing to be informed about neonate*s incidental findings following MRI  assessment All fetuses/neonates: • Preeclampsia or fetal growth restriction at time of inclusion • Neurological illness or structural brain abnormalities • Suspected congenital anomalies or syndromes known to affect neurodevelopment • Chromosomal abnormalities • Genetic abnormalities known to impact neurodevelopment • Premature birth (< 37 weeks) Pregnant women and their partners without SMI: • A lifetime diagnosis of SMI in the mood-psychosis spectrum as assessed with  the Mini-International Neuropsychiatric Interview (M.I.N.I.; Sheehan et al.,  1998) • An SMI in the mood-psychosis spectrum in their first degree relatives • Use of neurotrophic medication In all (future) parents, (co)morbidity with other psychiatric diagnoses is not  an exclusion criterion.

Design outcomes

Primary

MeasureTime frame
Feasibility: The percentage of (future) parents participating in all three visits using MRI assessments. The study will be considered feasible when >=30% of invited couples participates in at least one visit including MRI assessment. Differences between neurodevelopmental trajectories of fetuses/neonates from parents with vs. without severe mental illness, as measured by: - Brain volume, cortical folding, cortical thickness, and cortical surface (global measures and local regions) from T1 and T2 weighted images. - Fractional anisotrophy (FA), mean diffusivity, axial diffusivity, radial diffusivity (per fiber and voxel based) from diffusion MRI (dMRI) images. - Brain activation during resting state (per region and voxel based) from resting-state fMRI (rs-fMRI) images. - Graph theory metrics from FA (via dMRI) and rs-fMRI. - Measurements of fetal growth and development, such as: biparietal diameter (BPD), transverse cerebellar diameter (TCD), head circumference (HC), thalamus, femur length (FL), and abdominal circumference (AC), estimated fetal weight, insula depth, Sylvian fissure depth, and parietal-occipital fissures (POF) depth, using 2D and 3D fetal ultrasound. - Doppler fetal hemodynamics, such as: umbilical artery (UA), middle cerebral artery (MCA), and estimated cerebro-placental ratio (CPR).

Secondary

MeasureTime frame
- Clinical features, i.e. parental psychosis, depression, or mania diagnoses and symptoms, age of onset parental disorder, number of episodes, number of hospitalizations, GAF score - Parental bonding - Polygenic risk scores for psychiatric traits - Cortisol levels - Development of the offspring

Countries

Netherlands

Contacts

Public ContactM.I. Broer

Erasmus MC, Universitair Medisch Centrum Rotterdam

m.broer@erasmusmc.nl010-70 32085

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)