Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum (LAMP)
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ClinicalTrials.gov Identifier: NCT05766007 |
Recruitment Status :
Recruiting
First Posted : March 13, 2023
Last Update Posted : December 27, 2023
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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.
Condition or disease |
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Schizophrenia Psychosis Mania Pregnancy Drug Exposure in Utero Drug Exposure Via Breast Milk Antipsychotic Agents Breastfeeding |
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.
Study Type : | Observational |
Estimated Enrollment : | 125 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum: An Observational Cohort Study |
Actual Study Start Date : | August 1, 2023 |
Estimated Primary Completion Date : | July 14, 2025 |
Estimated Study Completion Date : | August 2025 |
Group/Cohort |
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Risperidone
Pregnant or breastfeeding women receiving the long acting injectable form of Risperidone and their babies
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Paliperidone palmitate
Pregnant or breastfeeding women receiving Paliperidone palmitate and their babies
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Flupentixol decanoate
Pregnant or breastfeeding women receiving the Flupentixol decanoate and their babies
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Zuclopenthixol decanoate
Pregnant or breastfeeding women receiving the Zuclopenthixol decanoate and their babies
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Fluphenazine decanoate
Pregnant or breastfeeding women receiving the Fluphenazine decanoate and their babies
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- 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
- Minimum breastmilk drug concentration (Cmin) [ Time Frame: During weeks 9-12 weeks postpartum ]Determined from sampling at the end of a postpartum dosing interval
- 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
- Maximum breastmilk drug concentration (Cmin) [ Time Frame: During weeks 9-12 weeks postpartum ]Highest concentration during a postpartum dosing interval
- 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
- Area under the breastmilk concentration-time curve (AUC) [ Time Frame: During weeks 9-12 weeks postpartum ]For assessment of overall drug exposure in breastmilk
- 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
- 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
- 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)
- 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.
- 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
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05766007
Contact: Adeniyi Olagunju, BPharm MRes PhD | +44151 794 0418 | olagunju@liverpool.ac.uk |
Nigeria | |
Federal Medical Centre | Recruiting |
Makurdi, Benue State, Nigeria | |
Contact: Fetus Ighagbon, MBChB FMCPsych ighagbonfestus@gmail.com | |
Federal Neuropsychiatric Hospital | Recruiting |
Kaduna, Kaduna State, Nigeria | |
Contact: Omeiza Beida, MBBS FMCPsych omeizabeida@gmail.com | |
Federal Neuropsychiatric Hospital | Recruiting |
Yaba, Lagos State, Nigeria | |
Contact: Dapo Adegbaju, MBBS FMCPsych dapsydawaj1@yahoo.com | |
Neuropsychiatric Hospital | Recruiting |
Abeokuta, Ogun State, Nigeria | |
Contact: Olorunfemi Ogunwobi, MBBS FWACP Psych olorunfemi.ogunwobi@bowen.edu.ng | |
Neuropsychiatric Specialist Hospital | Recruiting |
Akure, Ondo State, Nigeria | |
Contact: Akinwumi Akinnuoye, MBBS FMCPsych akinnuoyeakinwumi01@gmail.com | |
Obafemi Awolowo University Teaching Hospital | Not yet recruiting |
Ile-Ife, Osun State, Nigeria | |
Contact: Sanmi Akinsulore, MBChB FMCPsych sanmilore@oauife.edu.ng |
Study Chair: | Adeniyi Olagunju, PhD | University of Liverpool |
Responsible Party: | University of Liverpool |
ClinicalTrials.gov Identifier: | NCT05766007 |
Other Study ID Numbers: |
UoL001749 |
First Posted: | March 13, 2023 Key Record Dates |
Last Update Posted: | December 27, 2023 |
Last Verified: | December 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
mental ill health pregnancy postpartum long-acting injectable antipsychotics Risperidone |
Paliperidone palmitate Fluphenazine decanoate Flupentixol decanoate Zuclopenthixol decanoate |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |