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NCT Number: NCT05766007

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

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.

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Key information

Conditions

Schizophrenia Antipsychotic Agents Behavior Breast Feeding Breastfeeding Drug Exposure Via Breast Milk Drug Exposure in Utero Feeding Behavior Mania Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Pregnancy Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Federal Medical Centre, Makurdi, Benue State, Nigeria

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About this study

Primary Objectives

  • 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.
  • To describe breastmilk pharmacokinetics of selected LAIAs and the extent of breastfed infant exposure.

Secondary Objectives

  • To assess safety and clinical outcomes following LAIA use during pregnancy and postpartum.
  • To explore sources of variability in maternal and fetal/breastfed infant LAIA exposure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Minimum plasma drug concentration (Cmin) during pregnancy and postpartum

    Time frame: During gestation weeks 33-36 and weeks 9-12 weeks postpartum

    Determined from sampling at the end of a dosing interval during pregnancy, and postpartum

  2. Minimum breastmilk drug concentration (Cmin)

    Time frame: During weeks 9-12 weeks postpartum

    Determined from sampling at the end of a postpartum dosing interval

  3. Maximum plasma drug concentration (Cmin) during pregnancy and postpartum

    Time frame: During gestation weeks 33-36 and weeks 9-12 weeks postpartum

    Highest concentration during a dosing interval during pregnancy, and postpartum

  4. Maximum breastmilk drug concentration (Cmin)

    Time frame: During weeks 9-12 weeks postpartum

    Highest concentration during a postpartum dosing interval

  5. Area under the plasma concentration-time curve (AUC)

    Time frame: During gestation weeks 33-36 and weeks 9-12 weeks postpartum

    For assessment of overall drug exposure in plasma

  6. Area under the breastmilk concentration-time curve (AUC)

    Time frame: During weeks 9-12 weeks postpartum

    For assessment of overall drug exposure in breastmilk

  7. Breastfed infant to maternal plasma LAIA concentration ratio

    Time frame: During weeks 9-12 weeks postpartum

    To determine the level of breastfed infant LAIA exposure and elimination

  8. Newborn to maternal plasma LAIA concentration ratio

    Time frame: As soon as possible after delivery

    To determine the extent of in utero fetal drug exposure and elimination

Secondary outcomes

  1. LAIA associated symptoms

    Time frame: From gestation week 28 to postpartum week 12

    To monitor LAIA side effects during and postpartum using the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS)

  2. Clinical improvement

    Time frame: From gestation week 28 to postpartum week 12

    To monitor illness severity, improvement and LAIA efficacy during pregnancy and postpartum using the Clinical Global Impressions Scale.

  3. Single nucleotide polymorphisms in drug disposition genes

    Time frame: From gestation week 28 to postpartum week 12

    To explore genetic sources of interindividual variability in maternal and fetal/breastfed infant drug exposure

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Federal Medical Centre, Makurdi
  • Federal Neuropsychiatric Hospital, Kaduna
  • Federal Neuropsychiatric Hospital, Yaba
  • Neuropsychiatric Hospital, Abeokuta
  • Neuropsychiatric Specialist Hospital, Akure

Registry information

Official study title

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

Acronym: LAMP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2023
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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