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Maternal And Infant Antipsychotic Study
Developmental Effects of Antenatal Exposure to Antipsychotics
Who can join
Ages 18 and older · Women
Full eligibility criteria
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
About the study
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.
What is being tested
- Antipsychotics (drug)
- Non-antipsychotic medication (drug)
- No Medication (other)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 74 · Started: Sep 29, 2023
Contact the study team
- Floriana Milazzo, MPH · Phone: (212) 659-1326
- Veerle Bergink, MD, PhD · Phone: 2126591326
Official record on ClinicalTrials.gov — NCT06049953
Locations in the U.S.
| New York | Icahn School of Medicine at Mount Sinai, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.