NIH-funded research R01 grant

Antipsychotic use during pregnancy and infant development

Official title: Developmental effects of antenatal exposure to antipsychotics

Funded at Icahn School of Medicine at Mount Sinai · NIH-11530214 · Data updated 2026-11-12

This project follows pregnant women with severe mental illness to see how taking antipsychotics during pregnancy affects maternal health, baby health at birth, and child development in the first 6 months.

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 startJune 1, 2023
Project endApril 30, 2028
Funding year2026
Award (this year)$180,187
NIH project number3R01HD111117-04S1
Project IDNIH-11530214 on NIH RePORTER

Who could benefit from this research

Could help

Pregnant women with severe mental illness who are considering or receiving antipsychotic treatment.

Less likely to help

Pregnant women with severe mental illness not using antipsychotics and those without the condition may not experience direct benefits from this study.

What this research studies

If you are pregnant and have a serious mental illness, this study will observe your psychiatric course and look at how medications, including antipsychotics, influence outcomes for you and your baby. Researchers will compare those who take antipsychotics with those who take other medications or no medication, using careful matching to reduce confounding. They will collect detailed information about home environment, relationships, and health to understand factors that could impact outcomes and will analyze infant development at 6 months. The goal is to understand whether antipsychotics are effective for pregnant women with severe illness and whether they have any measurable effects on the newborn and early development.

Why it matters

Potential benefit: If successful, the study could clarify safety and effectiveness of antipsychotics in pregnancy, guiding safer treatment decisions for mothers and healthier development for babies.

How similar studies have gone: This approach builds on observational methods used in perinatal psychiatry and has shown value in understanding medication safety and outcomes.

Where this research is happening

  • Icahn School of Medicine at Mount Sinai
    New York, United States
    Active

Researchers

  • Principal investigator: Robakis, Thalia K — Icahn School of Medicine at Mount Sinai
  • Study coordinator: Robakis, Thalia K

Related research

Other NIH-funded projects on the same topics.

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.
Last reviewed 2026-11-14 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.