Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Liverpool
With
Federal Neuropsychiatric Hospital, Yaba
Federal Neuropsychiatric Hospital, Kaduna
Neuropsychiatric Hospital, Abeokuta
Neuropsychiatric Specialist Hospital, Akure
Federal Medical Centre, Makurdi
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.
Age
18–49
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
