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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05766007
Recruitment Status : Recruiting
First Posted : March 13, 2023
Last Update Posted : December 27, 2023
Sponsor:
Collaborators:
Federal Neuropsychiatric Hospital, Yaba
Federal Neuropsychiatric Hospital, Kaduna
Neuropsychiatric Hospital, Abeokuta
Neuropsychiatric Specialist Hospital, Akure
Obafemi Awolowo University Teaching Hospital
Federal Medical Centre, Makurdi
Information provided by (Responsible Party):
University of Liverpool

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.


Condition or disease
Schizophrenia Psychosis Mania Pregnancy Drug Exposure in Utero Drug Exposure Via Breast Milk Antipsychotic Agents 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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

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



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Dried blood spots and dried breastmilk spots on protein saver cards


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
Pregnant and postpartum women, at least 18 years old receiving maintenance dose of long-acting injectable antipsychotics (LAIA).
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

Information from the National Library of Medicine

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


Contacts
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Contact: Adeniyi Olagunju, BPharm MRes PhD +44151 794 0418 olagunju@liverpool.ac.uk

Locations
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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   
Sponsors and Collaborators
University of Liverpool
Federal Neuropsychiatric Hospital, Yaba
Federal Neuropsychiatric Hospital, Kaduna
Neuropsychiatric Hospital, Abeokuta
Neuropsychiatric Specialist Hospital, Akure
Obafemi Awolowo University Teaching Hospital
Federal Medical Centre, Makurdi
Investigators
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Study Chair: Adeniyi Olagunju, PhD University of Liverpool
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Liverpool:
mental ill health
pregnancy
postpartum
long-acting injectable antipsychotics
Risperidone
Paliperidone palmitate
Fluphenazine decanoate
Flupentixol decanoate
Zuclopenthixol decanoate
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders