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Maternal And Infant Antipsychotic Study

NCT06049953 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-09-29

No results posted yet for this study

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.

Conditions

  • Antipsychotics
  • Pregnancy

Interventions

DRUG

Antipsychotics

Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.

DRUG

Non-antipsychotic medication

Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and/or insomnia.

OTHER

No Medication

Non-psychotropic medications

Sponsors & Collaborators

Principal Investigators

  • Thalia Robakis, MD, PhD · Icahn School of Medicine at Mount Sinai

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2027-06-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06049953 on ClinicalTrials.gov