Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum (LAMP)

University of Liverpool

Status: Enrolling

Conditions: Antipsychotic Agents; Drug Exposure in Utero; Psychosis; Schizophrenia; Breastfeeding; Mania; Drug Exposure Via Breast Milk; Pregnancy

Study type: Observational

Funder types: Other

Identifiers

NCT05766007

UoL001749

Details and patient eligibility

About

The goal of this observational study is to learn about how long-acting injectable antipsychotic (LAIA) medications are affected by the changes that take place in the body during pregnancy, and how much an unborn baby is exposed to. The investigators are also interested in the amount of these drugs that enters into breastmilk and taken by babies during breastfeeding.

In addition to their regular clinic visits to receive long-acting mental health medicine injection, participants will be invited for up to four study visits between day 2 and 14 after the injection. This will happen only once during pregnancy, and once during the breastfeeding period to collect a few drops of blood on special filter paper card from the finger using safety lancet. A few drops of breastmilk will also be collected. Immediately after delivery, a few drops of blood will be collected from the mother, umbilical cord and the baby heel.

The investigators will use these samples to determine the amount of the drug in the body during pregnancy and compare this to the amount during the breastfeeding period. Additionally, every month during the third trimester, and during the first 3 months postpartum, participants will complete a questionnaire (using the Liverpool University Neuroleptic Side Effect Scale) to document how they are feeling. Clinical improvement will be documented by the primary care provider using the Clinical Global Impressions Scale.

Findings from this study are expected to help healthcare providers to understand these drugs better so that they can make informed decisions about if and how to use these drugs in women who become pregnant or are breastfeeding.

Full description

Primary Objectives

1. To determine the magnitude of changes (if any) in the pharmacokinetics of selected LAIAs during pregnancy and assess the extent of fetal exposure at delivery.
2. To describe breastmilk pharmacokinetics of selected LAIAs and the extent of breastfed infant exposure.

Secondary Objectives

1. To assess safety and clinical outcomes following LAIA use during pregnancy and postpartum.
2. To explore sources of variability in maternal and fetal/breastfed infant LAIA exposure.

Enrollment: 125 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

125 participants in 5 patient groups

Risperidone

Description:

Pregnant or breastfeeding women receiving the long acting injectable form of Risperidone and their babies

Paliperidone palmitate

Description:

Pregnant or breastfeeding women receiving Paliperidone palmitate and their babies

Flupentixol decanoate

Description:

Pregnant or breastfeeding women receiving the Flupentixol decanoate and their babies

Zuclopenthixol decanoate

Description:

Pregnant or breastfeeding women receiving the Zuclopenthixol decanoate and their babies

Fluphenazine decanoate

Description:

Pregnant or breastfeeding women receiving the Fluphenazine decanoate and their babies