RECRUITING

Maternal And Infant Antipsychotic Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Developmental Effects of Antenatal Exposure to Antipsychotics

Quick Facts

Study Start:2023-09-29
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06049953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant
  2. * Severe mental illness, including:
  3. * Psychotic disorder (affective and nonaffective)
  4. * Bipolar disorder
  5. * History of psychiatric hospitalization, regardless of diagnosis
  6. * Able to complete study interviews and measures in English, Dutch, or Spanish
  1. * Active substance use disorder in pregnancy
  2. * Insufficiently high-functioning to provide full informed consent and/or participate in study procedures

Contacts and Locations

Study Contact

Floriana Milazzo, MS
CONTACT
(212) 659-1326
floriana.milazzo@mssm.edu
Veerle Bergink, MD, PhD
CONTACT
2126591326
veerle.bergink@mssm.edu

Principal Investigator

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

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-29
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2023-09-29
Study Completion Date2027-12-01

Terms related to this study

Keywords Provided by Researchers

  • antipsychotic
  • pregnancy
  • severe mental illness
  • neonatal adaptation syndrome
  • neurodevelopment

Additional Relevant MeSH Terms

  • Antipsychotics
  • Pregnancy