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Imaging the neurodevelopmental consequences of intrauterine exposure to Antipsychotics and Lithium

Imaging the neurodevelopmental consequences of intrauterine exposure to Antipsychotics and Lithium - The Image_AL study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47026
Enrollment
441
Registered
2016-10-03
Start date
2017-02-12
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Concequences of intrauterine exposure to lithium or antipyschotics

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Children born between 2003-2012: - Children of mothers treated with antipsychotics or lithium during pregnancy - Children of mothers diagnosed with one of the following disorders during pregnancy: bipolar disorder, schizophrenia, schizoaffective disorder, psychosis NOS or borderline personality disorder. - Children of mothers who developed postpartum psychosis (PP) after childbirth. - Children of women who developed schizophrenia within five years postpartum.

Exclusion criteria

Exclusion criteria: Children will be excluded if they were exposed to both lithium and antipsychotics in utero, or if their mother used recreational drugs or antiepileptic medication during pregnancy.

Design outcomes

Primary

MeasureTime frame
A Magnetic Resonance Imaging (MRI) brain scan will be performed in children aged 8 years or older at the research location. MR images are required on a 3 Tesla scanner. The scanning protocol will contain a whole-brain structural MRI examination combined with Diffusion Tensor Imaging (DTI) and functional MRI (fMRI). Primary measures will include: intracranial volume, total brain volume, total gray and white matter, volumes of the four cortical lobes and subcortical structures, cerebellar volume, ventricular volume and cortical thickness. Maps of fractional anisotropy will be calculated (DTI).

Secondary

MeasureTime frame
fMRI: The fMRI session will include resting state MRI and the Sternberg Item Recognition Task (SIRT) for working memory. Neuropsychological testing (children from the age of 6 years old): To examine neuropsychological development of the child we use a selection of subtests from the NEPSY-II-NL assessment. Cognitive testing: Intelligence (IQ) of the children and the accompanying parent will be assessed by the Snijders-Oomen Niet-verbale intelligentie Test - Revisie (SON-R 6-40). Behavioural testing: For behavioural testing we use the Achenbach System of Empirically Based Assessment (ASEBA) including: - Child Behaviour Checklist/6-18 (CBCL) is a checklist completed by the parents or a caregiver to identify problem behaviour in the child. The checklist contains 120 questions. - Youth Self Report (YSR) is a self report checklist completed by the child from the age of 11 years old. The checklist contains questions about skills and emotional and behavioural problems. - Teacher*s Report Form/ 6-18 (TRF) is a questionnaire filled out by the teacher. It identifies behavioural problems viewed from a teacher*s perspective. The scores of the CBCL and the TRF will be combined into one total multi-informant score. - The Social Responsiveness Scale (SRS-2) is a screening instrument designed to assess symptoms of Autism Spectrum Disorders. This questionnaire will be completed by the parent. Additionally, the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID), a short structured diagnostic interview for DSM-IV and ICD-10 psychiatric disorders in children and adolescents, will be administered to all children. Hormone measurements in hair: A small string of hair will be obtained from all participants. This will be used to determine hormone levels (in particular cortisol) in the months prior to the time of obtainment. Long-term cortisol levels in hair provide a relatively easy and non-invasive measure of HPA-axis func

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)