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Maternal And Infant Antipsychotic Study
Sponsor: 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.
Official title: Developmental Effects of Antenatal Exposure to Antipsychotics
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2023-09-29
Completion Date
2027-12-01
Last Updated
2025-09-29
Healthy Volunteers
No
Conditions
Interventions
Antipsychotics
Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.
Non-antipsychotic medication
Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and/or insomnia.
No Medication
Non-psychotropic medications
Locations (1)
Icahn School of Medicine at Mount Sinai
New York, New York, United States