Developmental Effects of Antenatal Exposure to Antipsychotics
Icahn School of Medicine at Mount Sinai
Summary
The goal of this observational study is to learn about maternal psychiatric course and infant development in pregnant individuals with severe mental illness, comparing those treated with antipsychotics to those treated with other medications or without medication. The main questions it aims to answer are: 1. Is risk of psychiatric relapse different among individuals who take antipsychotic medication, other medication, or no medication? 2. Are pregnancy and neonatal health outcomes different among individuals who take antipsychotic medication, other medication, or no medication? 3. Do infant behavior and neurodevelopment differ among babies who were exposed to antipsychotic medication, other medication, or no medication in utero? Participants will * complete a psychiatric interview and questionnaires while pregnant; * donate blood from the mother and from the umbilical cord at delivery * have their babies participate in infant behavior evaluations and an EEG procedure. Researchers will compare these outcomes among individuals who were treated either with antipsychotic medication, with psychotropic medications of other classes, and with no medication, to see if psychiatric benefits for the mother and health outcomes for mother and child differ among these three types of treatment.
Description
Antipsychotic (AP) medications are widely prescribed for a range of mental illnesses including bipolar disorder and nonaffective psychosis. These disorders usually onset in adolescence or early adulthood; thus, women of childbearing age are among those prescribed APs. The number of pregnancies exposed to APs has been increasing over time. Yet their efficacy has never been definitively demonstrated in this population. APs cross the placenta and block dopamine (DA) D2 receptors, which are functional in the developing fetus, including influencing the proliferation and differentiation of neural p…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Pregnant * Severe mental illness, including: * Psychotic disorder (affective and nonaffective) * Bipolar disorder * History of psychiatric hospitalization, regardless of diagnosis * Able to complete study interviews and measures in English, Dutch, or Spanish Exclusion Criteria: * Active substance use disorder in pregnancy * Insufficiently high-functioning to provide full informed consent and/or participate in study procedures
Interventions
- DrugAntipsychotics
Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.
- DrugNon-antipsychotic medication
Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and/or insomnia.
- OtherNo Medication
Non-psychotropic medications
Location
- Icahn School of Medicine at Mount SinaiNew York, New York