Actively Recruiting
Maternal And Infant Antipsychotic Study
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-09-29
200
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
E
Erasmus Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Maternal And Infant Antipsychotic Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant
- Diagnosis of severe mental illness, including psychotic disorder (affective and nonaffective) or bipolar disorder
- History of psychiatric hospitalization, regardless of diagnosis
- Able to complete study interviews and measures in English, Dutch, or Spanish
You will not qualify if you...
- Active substance use disorder during pregnancy
- Not sufficiently high-functioning to provide informed consent or participate in study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
F
Floriana Milazzo, MPH
CONTACT
V
Veerle Bergink, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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