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Imaging the neurodevelopmental consequences of intrauterine exposure to Antipsychotics and Lithium

Completed
Conditions
Concequences of intrauterine exposure to lithium or antipyschotics
10026908
10037173
Registration Number
NL-OMON47026
Lead Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
441
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.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>A Magnetic Resonance Imaging (MRI) brain scan will be performed in children<br /><br>aged 8 years or older at the research location. MR images are required on a 3<br /><br>Tesla scanner. The scanning protocol will contain a whole-brain structural MRI<br /><br>examination combined with Diffusion Tensor Imaging (DTI) and functional MRI<br /><br>(fMRI). Primary measures will include: intracranial volume, total brain<br /><br>volume, total gray and white matter, volumes of the four cortical lobes and<br /><br>subcortical structures, cerebellar volume, ventricular volume and cortical<br /><br>thickness. Maps of fractional anisotropy will be calculated (DTI). </p><br>
Secondary Outcome Measures
NameTimeMethod
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