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Pregnancy and mental health: new study investigates antipsychotic risks for mom and baby

NCT ID NCT06049953

Knowledge-focused Sponsor: Icahn School of Medicine at Mount Sinai Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This observational study follows 74 pregnant individuals with severe mental illness to see how taking antipsychotics (versus other medications or no medication) affects psychiatric stability and infant development. Participants complete psychiatric interviews, donate blood, and have their babies undergo behavior evaluations and brain activity tests. The goal is to better understand the trade-offs between treating maternal mental illness and potential risks to the child.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Antipsychotics
What this could lead to
If successful, this study could help doctors and pregnant individuals make more informed decisions about using antipsychotics during pregnancy, balancing maternal mental health with infant safety.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by underlying illness severity or other factors, and the small sample size limits generalizability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women with severe mental illness as defined in Eligibility Criteria

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bipolar disorder psychiatric disorder psychotic disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antipsychotics Pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

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