Maternal And Infant Antipsychotic Study

ID#: NCT06049953

Age: 18 years - 66+

Gender: Female

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: September 29, 2023

End Date: August 01, 2027

Contact Information:
Thalia Robakis, MD, PhD
2126598893
Veerle Bergink, MD, PhD
2126591326
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 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.
Eligibility:

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
Find a Clinical Trial