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

Schizophrenia Clinical Trial

— LAMP  

Official title:

Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum: An Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766007
• Other study ID #: UoL001749
• Status: Recruiting
• Start date: August 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: December 2023
• Source: University of Liverpool
• Contact: Adeniyi Olagunju, BPharm MRes PhD
• Phone: +44151 794 0418
• Email: olagunju[@]liverpool.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: August 2025
• Est. primary completion date: July 14, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Antipsychotic Agents
• Breastfeeding
• Mania
• Pregnancy
• Psychosis
• Schizophrenia

Locations

Country	Name	City	State
Nigeria	Neuropsychiatric Hospital	Abeokuta	Ogun State
Nigeria	Neuropsychiatric Specialist Hospital	Akure	Ondo State
Nigeria	Obafemi Awolowo University Teaching Hospital	Ile-Ife	Osun State
Nigeria	Federal Neuropsychiatric Hospital	Kaduna	Kaduna State
Nigeria	Federal Medical Centre	Makurdi	Benue State
Nigeria	Federal Neuropsychiatric Hospital	Yaba	Lagos State

Sponsors (7)

Lead Sponsor	Collaborator
University of Liverpool	Federal Medical Centre, Makurdi, Federal Neuropsychiatric Hospital, Kaduna, Federal Neuropsychiatric Hospital, Yaba, Neuropsychiatric Hospital, Abeokuta, Neuropsychiatric Specialist Hospital, Akure, Obafemi Awolowo University Teaching Hospital

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum plasma drug concentration (Cmin) during pregnancy and postpartum	Determined from sampling at the end of a dosing interval during pregnancy, and postpartum	During gestation weeks 33-36 and weeks 9-12 weeks postpartum
Primary	Minimum breastmilk drug concentration (Cmin)	Determined from sampling at the end of a postpartum dosing interval	During weeks 9-12 weeks postpartum
Primary	Maximum plasma drug concentration (Cmin) during pregnancy and postpartum	Highest concentration during a dosing interval during pregnancy, and postpartum	During gestation weeks 33-36 and weeks 9-12 weeks postpartum
Primary	Maximum breastmilk drug concentration (Cmin)	Highest concentration during a postpartum dosing interval	During weeks 9-12 weeks postpartum
Primary	Area under the plasma concentration-time curve (AUC)	For assessment of overall drug exposure in plasma	During gestation weeks 33-36 and weeks 9-12 weeks postpartum
Primary	Area under the breastmilk concentration-time curve (AUC)	For assessment of overall drug exposure in breastmilk	During weeks 9-12 weeks postpartum
Primary	Breastfed infant to maternal plasma LAIA concentration ratio	To determine the level of breastfed infant LAIA exposure and elimination	During weeks 9-12 weeks postpartum
Primary	Newborn to maternal plasma LAIA concentration ratio	To determine the extent of in utero fetal drug exposure and elimination	As soon as possible after delivery
Secondary	LAIA associated symptoms	To monitor LAIA side effects during and postpartum using the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS)	From gestation week 28 to postpartum week 12
Secondary	Clinical improvement	To monitor illness severity, improvement and LAIA efficacy during pregnancy and postpartum using the Clinical Global Impressions Scale.	From gestation week 28 to postpartum week 12
Secondary	Single nucleotide polymorphisms in drug disposition genes	To explore genetic sources of interindividual variability in maternal and fetal/breastfed infant drug exposure	From gestation week 28 to postpartum week 12