Study on the effects of antipsychotic medications during pregnancy on mothers and infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the psychiatric course of pregnant individuals with severe mental illness and the developmental outcomes of their infants. It compares those treated with antipsychotics to those receiving other medications or no medication at all. Participants will undergo psychiatric interviews, complete questionnaires, and provide blood samples at delivery, while their infants will be evaluated for behavior and undergo EEG procedures. The study seeks to understand the risks of psychiatric relapse and differences in pregnancy and neonatal health outcomes based on medication exposure.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Thalia Robakis, MD, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Floriana Milazzo, MPH
• Email: floriana.milazzo@mssm.edu
• Phone: (212) 659-1326

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.