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Search / Trial NCT06049953

Maternal And Infant Antipsychotic Study

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Sep 16, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Antipsychotic Pregnancy Severe Mental Illness Neonatal Adaptation Syndrome Neurodevelopment

ClinConnect Summary

The Maternal And Infant Antipsychotic Study is designed to understand how different treatments affect pregnant individuals with severe mental illnesses, such as bipolar disorder or psychotic disorders. The study compares those who take antipsychotic medications to those who use other types of medications or none at all. Researchers want to find out if taking these medications makes a difference in the mother's mental health, the health of the baby during pregnancy and after birth, and how the baby develops behaviorally and neurologically.

To qualify for this study, participants must be pregnant and have a severe mental illness, and they should be able to communicate in English, Dutch, or Spanish. During the study, participants will undergo interviews, provide blood samples at delivery, and have their babies evaluated for behavior and brain activity. This research aims to help improve treatment options for pregnant individuals dealing with severe mental health issues, ensuring better outcomes for both mothers and their babies.

Gender

FEMALE

Eligibility 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

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Thalia Robakis, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported