servere mental illness psychotic disorders servere mental illness psychotic disorders
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Main study parameter is relapse with mood or psychotic episode as determined by MINI psychiatric interview during the peripartum period. | — |
Secondary
| Measure | Time 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
Erasmus MC, Universitair Medisch Centrum Rotterdam