Antipsychotic use during pregnancy and baby development

Developmental effects of antenatal exposure to antipsychotics

NIH-funded research Icahn School of Medicine at Mount Sinai · NIH-11322639

Researchers will follow pregnant people with severe mental illness and their babies to compare outcomes for those who take antipsychotics, other psychiatric medicines, or no medication, tracking maternal relapse, infant brain activity, and early behavior.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionIcahn School of Medicine at Mount Sinai NIH-funded
Lab location1 site (New York, United States)
Project IDNIH-11322639 on NIH RePORTER

What this research studies

If you are pregnant and have a severe mental illness, the team will follow you through pregnancy and after birth to track your symptoms and treatments. They will compare outcomes for people who take antipsychotics, those who take other psychiatric medications, and those who use no medication. Your baby would have a noninvasive EEG at 6 months and a behavioral and social development check at 18 months, and the researchers will record any psychiatric relapse in you. The goal is to provide clearer information about how antipsychotic use in pregnancy relates to maternal health and early brain and behavioral signs in children.

Who could benefit from this research

Good fit: Ideal participants are pregnant people with severe mental illness (including bipolar disorder) who are willing to share treatment and health information and bring their infants for EEG and follow-up visits.

Not a fit: People who are not pregnant, who cannot attend clinic visits in New York, or who are unwilling to have their infant undergo follow-up assessments are unlikely to be able to participate or benefit directly.

Why it matters

Potential benefit: If successful, the findings could help pregnant people with serious mental illness and their clinicians make safer, more informed medication decisions and monitor infants for early signs of problems.

How similar studies have performed: Previous observational studies have suggested possible neonatal and developmental effects of prenatal antipsychotic exposure, but prospective studies using infant EEG and longer follow-up are limited.

Where this research is happening

New York, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Bipolar Disorder
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.