Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New study sheds light on antipsychotic safety during pregnancy and breastfeeding

NCT ID NCT05766007

Knowledge-focused Sponsor: University of Liverpool Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed observational study followed 168 pregnant or breastfeeding women with schizophrenia, psychosis, or mania who were already taking long-acting injectable antipsychotics. Researchers measured drug levels in the mother's blood, breastmilk, and the baby's blood to understand how pregnancy affects drug exposure. The goal is to help healthcare providers make informed decisions about using these medications during pregnancy and while breastfeeding.

What this could mean

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

Active substance
long-acting injectable antipsychotics (Risperidone, Paliperidone palmitate, Fluphenazine decanoate, Flupenthixol decanoate, Zuclopenthixol decanoate)
What this could lead to
If successful, this study could help doctors better understand how to safely use long-acting antipsychotics in pregnant and breastfeeding women, improving care for both mother and baby.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly test new therapies. Results may not apply to all women or all antipsychotics, and the small sample size limits how much we can conclude.

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

168 people

The number who actually took part.

Started

Aug 2023

Finished

Nov 2025

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 and postpartum women, at least 18 years old receiving maintenance dose of long-acting injectable antipsychotics (LAIA).

Ages

18 to 49 years

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: * Currently pregnant or breastfeeding. * If pregnant, plans to deliver within the facility. * Diagnosis of schizophrenia, mania or other psychoses. * Prescription of long-acting injectable antipsychotic (Risperidone, Paliperidone palmitate, Fluphenazine decanoate, Flupenthixol decanoate and Zuclopenthixol decanoate) as maintenance therapy started before study entry. * Scheduled to receive at least one injection before delivery (if pregnant) or before week 12 postpartum (if breastfeeding). * At least 18 of age at study entry. Exclusion Criteria: * Unable to understand study information. * Unable to provide written informed consent. * Known hypersensitivity to study medication. * Record of poor medication adherence. * Personal circumstances will not allow completion of the schedule of study activities. * Concurrent use of agents with known or uncertain interaction with study drug. * Currently experiencing severe pregnancy related complications

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Antipsychotic agents are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Breast Feeding Mania psychotic disorder Psychotic Disorders schizophrenia

As listed by the trial registrant

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

Antipsychotic agents Breastfeeding Drug exposure in utero Drug exposure via breast milk Mania Pregnancy Psychosis Schizophrenia

Contacts and locations

Locations

  • Federal Medical Centre

    Makurdi, Benue State, Nigeria

  • Federal Neuropsychiatric Hospital

    Kaduna, Kaduna State, Nigeria

  • Federal Neuropsychiatric Hospital

    Yaba, Lagos, Nigeria

  • Neuropsychiatric Hospital

    Abeokuta, Ogun State, Nigeria

  • Neuropsychiatric Specialist Hospital

    Akure, Ondo State, Nigeria

  • Obafemi Awolowo University Teaching Hospital

    Ile-Ife, Osun State, Nigeria

More trials for these conditions

Other studies related to the condition(s) this trial covers.