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

Launched by UNIVERSITY OF LIVERPOOL · Mar 9, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how long-acting injectable antipsychotic medications, which help manage conditions like schizophrenia and psychosis, affect women during pregnancy and breastfeeding. The researchers want to understand how these medications change in the body during pregnancy, how much the unborn baby might be exposed to, and how much of the medication passes into breast milk. This information will help doctors make better decisions about using these medications for women who are pregnant or breastfeeding.

To participate in the study, women must be at least 18 years old, currently pregnant or breastfeeding, and diagnosed with a mental health condition that requires long-acting injectable antipsychotics. During the trial, participants will attend up to four additional visits after receiving their medication injection, where small samples of blood and breast milk will be collected. They will also fill out questionnaires about how they are feeling each month during the later stages of pregnancy and the first few months after giving birth. The findings from this study are expected to improve understanding of these medications and support better care for women during this important time.

Gender

FEMALE

Eligibility criteria

• 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