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MAIA

Developmental Effects of Antenatal Exposure to Antipsychotics - MAIA

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56645
Enrollment
100
Registered
2023-06-19
Start date
2024-03-24
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

servere mental illness psychotic disorders servere mental illness psychotic disorders

Interventions

none

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: - Pregnant - Severe mental illness • Psychotic disorder (affective and non-affective) • Bipolar disorder • History of psychiatric hospitalization, regardless of diagnosis. - Able to complete study interviews and measures in Dutch or EnglishInclusion criteria healthy control: - Psychiatrically healthy mother of infants under six months Written informed consent - Able to complete study interviews and measures in Dutch or English

Exclusion criteria

Exclusion criteria: - Acute psychotic or bipolar episode - Active substance use disorder in pregnancy - Insufficiently high-functioning to provide full informed consent and/or  participate in study procedures Exclusion criteria healthy control:Active substance use disorder in pregnancyinsufficiently high-functioning to provide full informed consent and/or participate in study procedures

Design outcomes

Primary

MeasureTime frame
Main study parameter is relapse with mood or psychotic episode as determined by MINI psychiatric interview during the peripartum period.

Secondary

MeasureTime frame
Secondary parameters for adverse pregnancy outcomes are total weight gain in pregnancy and body size measurements at 20 weeks* gestation and delivery. Medication concentrations in maternal blood at 6 months postpartum. Neonatal adaptation in neonates will be assessed using Finnegan scale in hospital after delivery. At six months of age sensory gating (P50) from EEG measurements will be measured. Infant development will be measured by Bayley Infant Development and Vineland Adaptive Behavior scales. Investigate how biological and (epi-)genetic factors in parents and offspring influence development in offspring.

Countries

Netherlands, United States

Contacts

Public ContactA.M. Kamperman

Erasmus MC, Universitair Medisch Centrum Rotterdam

a.kamperman@erasmusmc.nl0631145015

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026