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

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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Risperidone; Pregnant or breastfeeding women receiving the long acting injectable form of Risperidone and their babies
Paliperidone palmitate; Pregnant or breastfeeding women receiving Paliperidone palmitate and their babies
Flupentixol decanoate; Pregnant or breastfeeding women receiving the Flupentixol decanoate and their babies
Zuclopenthixol decanoate; Pregnant or breastfeeding women receiving the Zuclopenthixol decanoate and their babies
Fluphenazine decanoate; Pregnant or breastfeeding women receiving the Fluphenazine decanoate and their babies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Minimum breastmilk drug concentration (Cmin)	Determined from sampling at the end of a postpartum dosing interval	During weeks 9-12 weeks postpartum
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
Maximum breastmilk drug concentration (Cmin)	Highest concentration during a postpartum dosing interval	During weeks 9-12 weeks postpartum
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
Area under the breastmilk concentration-time curve (AUC)	For assessment of overall drug exposure in breastmilk	During weeks 9-12 weeks postpartum
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Liverpool
• Collaborators: Federal Medical Centre, Makurdi; Federal Neuropsychiatric Hospital, Yaba; Federal Neuropsychiatric Hospital, Kaduna; Neuropsychiatric Hospital, Abeokuta; Neuropsychiatric Specialist Hospital, Akure
• Investigators: Study Chair: Adeniyi Olagunju, PhD, University of Liverpool

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): November 21, 2025
• Study Completion (Actual): November 21, 2025

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; Risperidone; postpartum; Paliperidone palmitate; mental ill health; long-acting injectable antipsychotics; Fluphenazine decanoate; Flupentixol decanoate; Zuclopenthixol decanoate
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Feeding Behavior; Mania; Schizophrenia; Psychotic Disorders; Breast Feeding
• Other Study ID Numbers: UoL001749

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No