Status:
RECRUITING
Maternal And Infant Antipsychotic Study
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
Erasmus Medical Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Antipsychotics
Pregnancy
Eligibility:
FEMALE
18+ years
Brief Summary
The goal of this observational study is to learn about maternal psychiatric course and infant development in pregnant individuals with severe mental illness, comparing those treated with antipsychotic...
Detailed Description
Antipsychotic (AP) medications are widely prescribed for a range of mental illnesses including bipolar disorder and nonaffective psychosis. These disorders usually onset in adolescence or early adulth...
Eligibility Criteria
Inclusion
- 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
- Active substance use disorder in pregnancy
- Insufficiently high-functioning to provide full informed consent and/or participate in study procedures
Key Trial Info
Start Date :
September 29 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06049953
Start Date
September 29 2023
End Date
December 1 2027
Last Update
September 29 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029