1. To investigate whether children exposed to lithium or antipsychotics in utero have subtle structural brain differences compared to non-exposed children at the age of 8-14 years old (primary objective).2. To investigate whether children exposed to…
ID
Source
Brief title
Condition
- Maternal complications of pregnancy
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 functioning.
Background summary
Patients with bipolar disorder and schizophrenia are usually treated with
lithium and/or antipsychotics. Both medications are often continued during
pregnancy as discontinuing may induce disease relapse. However, the
consequences for the development of the child remain uncertain. Several studies
showed minor consequences on pregnancy outcome and congenital malformations.
Less is known about the long-term neurodevelopmental consequences of
intrauterine exposure to lithium or antipsychotics. The current study will
investigate effects of intrauterine exposure to lithium or antipsychotics in
children of mothers who used these medications during pregnancy.
Study objective
1. To investigate whether children exposed to lithium or antipsychotics in
utero have subtle structural brain differences compared to non-exposed children
at the age of 8-14 years old (primary objective).
2. To investigate whether children exposed to lithium or antipsychotics in
utero have functional brain differences compared to non-exposed children at the
age of 8-14 years old (secondary objective).
3. To investigate whether children exposed to lithium or antipsychotics in
utero have cognitive, emotional or behavioural problems at the age of 6-14
years old (secondary objective).
Study design
Clinical cohort study examining neurodevelopment after intrauterine exposure to
lithium or antipsychotics by MRI and cognitive and behavioural tests.
Study burden and risks
To our knowledge there are no medical risks associated with an MRI-scan. Since
this study is conducted in children, the actual MRI scan will be preceded by a
practice session in a mock scanner. The scanning session should be as pleasant
as possible. During the practice session the child will be asked and may
indicate (verbal and non-verbal) whether he/she wants to participate in the
investigation. The investigation will immediately be ended if the child, the
parent or the investigator desires. Both during the practice-session and during
the scan, the child is able to watch movies. There are no risks associated with
the neuropsychological and cognitive tasks.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56845.078.16 |