Maternal And Infant Antipsychotic Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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 criteria

Qualifiers

Pregnant

Psychotic disorder (affective and nonaffective)

Bipolar disorder

History of psychiatric hospitalization, regardless of diagnosis

Disqualifiers

Active substance use disorder in pregnancy

Insufficiently high-functioning to provide full informed consent and/or participate in study procedures

Trial design

Treatments tested in this trial

  • Antipsychotics
  • Non-antipsychotic medication
  • No Medication

Treatment groups

74 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Icahn School of Medicine at Mount Sinai

Lead sponsor

Erasmus Medical Center

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator