Maternal And Infant Antipsychotic Study

Recruiting now

Conditions studied: Antipsychotics, Pregnancy

In brief

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 antipsychotics to those treated with other medications or without medication. The main questions it aims to answer are: 1. Is risk of psychiatric relapse different among individuals who take antipsychotic medication, other medication, or no medication? 2. Are pregnancy and neonatal health outcomes different among individuals who take antipsychotic medication, other medication, or no medication? 3. Do infant behavior and neurodevelopment differ among babies who were exposed to antipsychotic medication, other medication, or no medication in utero? Participants will * complete a psychiatric interview and questionnaires while pregnant; * donate blood from the mother and from the umbilical cord at delivery * have their babies participate in infant behavior evaluations and an EEG procedure. Researchers will compare these outcomes among individuals who were treated either with antipsychotic medication, with psychotropic medications of other classes, and with no medication, to see if psychiatric benefits for the mother and health outcomes for mother and child differ among these three types of treatment.

Key facts

Study ID

NCT06049953

Run by

Icahn School of Medicine at Mount Sinai

People needed

74

Starts

2023-09-29

Expected to finish

2028-01-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Active substance use disorder in pregnancy
• Insufficiently high-functioning to provide full informed consent and/or participate in study procedures

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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