Study on the effects of antipsychotic medications during pregnancy on mothers and infants
Developmental Effects of Antenatal Exposure to Antipsychotics
This study looks at how taking antipsychotic medications during pregnancy affects both mothers with severe mental illness and the development of their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06049953 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals diagnosed with severe mental illnesses such as psychotic disorders or bipolar disorder.
Not a fit: Patients with active substance use disorders during pregnancy or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and effects of antipsychotic medications during pregnancy, potentially guiding treatment decisions for pregnant individuals with severe mental illness.
How similar studies have performed: While limited data exists on developmental outcomes associated with antenatal exposure to antipsychotics, this study aims to fill a significant gap in understanding, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.