Plain-English translation of NCT01246765 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This is a large research registry run by Massachusetts General Hospital that tracks pregnant women who are taking psychiatric medications — including antidepressants, ADHD medications, antipsychotics, and sleep aids. By collecting information from many women, researchers hope to learn whether these medications are safe during pregnancy and how they may affect newborn and child development.
Doctors often don't have enough reliable information to advise pregnant women about whether it's safe to continue psychiatric medications during pregnancy. This registry aims to fill that gap by gathering real-world data from hundreds of pregnant women so we can better understand the true risks and benefits.
You likely qualify if…
You likely don't qualify if…
You would share information about your pregnancy, your psychiatric medications, and your medical history over the phone with the research team. The registry will follow you during pregnancy and after your baby is born to track outcomes. Researchers may also ask about your baby's development in the first months and years of life to understand the long-term effects of prenatal medication exposure.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
United States
Alkermes, Inc., Eisai Inc.
Enrollment target
~5,000 participants
Started
November 2008
Primary completion
December 2033
Age range
18 Years – 45 Years
Sex
Female only
Last updated on clinicaltrials.gov in October 2025.
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Central contact
Bryn Rediger
Massachusetts General Hospital
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.