Recruiting

Antipsychotics vs. Other Medications

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06049953

Conditions

Antipsychotics

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antipsychotics

Non-antipsychotic medication

No Medication

Study Details

Brief 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

Study ID

NCT06049953

Start date

Sep 29, 2023

Status verified date

Jun, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

74 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Antipsychotics

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

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

No Medication

Non-psychotropic medications

Primary outcome measure

  • Mini-International Neuropsychiatric Interview [ Time Frame: through study completion, an average of 6 months postpartum ]
  • Finnegan Neonatal Abstinence Scoring System [ Time Frame: 24 hours postnatal ]
  • Ratio of auditory evoked potentials as measured by EEG [ Time Frame: 6 months postnatal ]

Central Contacts and Locations

Central contacts

Floriana Milazzo, MPH

(212) 659-1326floriana.milazzo@mssm.edu

Veerle Bergink, MD, PhD

2126591326veerle.bergink@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Thalia Robakis

2126598893thalia.robakis@mssm.edu

Luz Ospina

212-659-1326luz.ospina@mssm.edu

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-22.