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Maternal And Infant Antipsychotic Study

Recruitingn/aAges 18 Years - anyFemaleIcahn School of Medicine at Mount Sinai
NCT06049953 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 del

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📋 Eligibility rules (as published)
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
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What it tests

  • Antipsychotics
  • Non-antipsychotic medication
  • No Medication
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Where

1 site
Icahn School of Medicine at Mount Sinai
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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