Clinical trial NCT05766007: Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum
Official title: Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia
Psychosis
Mania
Pregnancy
Drug Exposure in Utero
Drug Exposure Via Breast Milk
Antipsychotic Agents
Breastfeeding
Keywords: mental ill health
pregnancy
postpartum
long-acting injectable antipsychotics
Risperidone
Paliperidone palmitate
Fluphenazine decanoate
Flupentixol decanoate
Zuclopenthixol decanoate
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Federal Neuropsychiatric Hospital, Yaba
name: Federal Neuropsychiatric Hospital, Kaduna
name: Neuropsychiatric Hospital, Abeokuta
name: Neuropsychiatric Specialist Hospital, Akure
name: Obafemi Awolowo University Teaching Hospital
name: Federal Medical Centre, Makurdi
First posted: 2023-03-13
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant and postpartum women, at least 18 years old receiving maintenance dose of long-acting injectable antipsychotics (LAIA).

Brief summary: 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.

Detailed 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.

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

Primary outcomes:
measure: Minimum plasma drug concentration (Cmin) during pregnancy and postpartum
timeFrame: During gestation weeks 33-36 and weeks 9-12 weeks postpartum
measure: Minimum breastmilk drug concentration (Cmin)
timeFrame: During weeks 9-12 weeks postpartum
measure: Maximum plasma drug concentration (Cmin) during pregnancy and postpartum
timeFrame: During gestation weeks 33-36 and weeks 9-12 weeks postpartum
measure: Maximum breastmilk drug concentration (Cmin)
timeFrame: During weeks 9-12 weeks postpartum
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: During gestation weeks 33-36 and weeks 9-12 weeks postpartum
measure: Area under the breastmilk concentration-time curve (AUC)
timeFrame: During weeks 9-12 weeks postpartum
measure: Breastfed infant to maternal plasma LAIA concentration ratio
timeFrame: During weeks 9-12 weeks postpartum
measure: Newborn to maternal plasma LAIA concentration ratio
timeFrame: As soon as possible after delivery
Secondary outcomes:
measure: LAIA associated symptoms
timeFrame: From gestation week 28 to postpartum week 12
measure: Clinical improvement
timeFrame: From gestation week 28 to postpartum week 12
measure: Single nucleotide polymorphisms in drug disposition genes
timeFrame: From gestation week 28 to postpartum week 12
Other outcomes:
Locations:
city: Makurdi
country: Nigeria
facility: Federal Medical Centre
state: Benue State
city: Kaduna
country: Nigeria
facility: Federal Neuropsychiatric Hospital
state: Kaduna State
city: Yaba
country: Nigeria
facility: Federal Neuropsychiatric Hospital
state: Lagos State
city: Abeokuta
country: Nigeria
facility: Neuropsychiatric Hospital
state: Ogun State
city: Akure
country: Nigeria
facility: Neuropsychiatric Specialist Hospital
state: Ondo State
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospital
state: Osun State
Study officials:
affiliation: University of Liverpool
name: Adeniyi Olagunju, PhD
role: STUDY_CHAIR
References: