Maternal And Infant Antipsychotic Study

Conditions

• Antipsychotics
• Pregnancy

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Antipsychotics — DRUG
  Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.
• Non-antipsychotic medication — DRUG
  Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and/or insomnia.
• No Medication — OTHER
  Non-psychotropic medications

Study Details

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.

Key Dates

Start date

Sep 29, 2023

Status verified

Sep 2025

Primary completion

Jun 1, 2027

Completion

Dec 1, 2027

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: No medication
  Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are not treated with any psychotropic medications during pregnancy.
• Arm: Antipsychotic medication
  Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are treated with any of the following medications during pregnancy: Quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, lurasidone, haloperidol, or any other medication in the first- or second-generation antipsychotic class. All orally administered, with dosages titrated to clinical effect by the participant's primary psychiatrist.
• Arm: Non-antipsychotic medication
  Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are treated with any psychotropic medications during pregnancy other than those listed.

Primary Outcome Measure

Mini-International Neuropsychiatric Interview [ Time Frame: through study completion, an average of 6 months postpartum ]

Central Contacts

• Floriana Milazzo, MPH
  (212) 659-1326
  [email protected]
• Veerle Bergink, MD, PhD
  2126591326
  [email protected]

Locations (1)

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