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

NCT05766007 | Recruiting

• 1 other identifier: UoL001749
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 6

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.

Conditions

Psychosis; Mania; Pregnancy; Drug Exposure in Utero; Drug Exposure Via Breast Milk; Antipsychotic Agents; Breastfeeding; Schizophrenia

Keywords

mental ill health; pregnancy; postpartum; long-acting injectable antipsychotics; Risperidone; Paliperidone palmitate; Fluphenazine decanoate; Flupentixol decanoate; Zuclopenthixol decanoate

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• LAIA associated symptoms

  From gestation week 28 to postpartum week 12

• Clinical improvement

  From gestation week 28 to postpartum week 12

• Single nucleotide polymorphisms in drug disposition genes

  From gestation week 28 to postpartum week 12

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Liverpool: lead
• Federal Neuropsychiatric Hospital, Yaba: collaborator
• Federal Neuropsychiatric Hospital, Kaduna: collaborator
• Neuropsychiatric Hospital, Abeokuta: collaborator
• Neuropsychiatric Specialist Hospital, Akure: collaborator
• Obafemi Awolowo University Teaching Hospital: collaborator
• Federal Medical Centre, Makurdi: collaborator

Study Sites (6)

Federal Medical Centre

Makurdi, Benue State, Nigeria

RECRUITING

Federal Neuropsychiatric Hospital

Kaduna, Kaduna State, Nigeria

RECRUITING

Federal Neuropsychiatric Hospital

Yaba, Lagos, Nigeria

RECRUITING

Neuropsychiatric Hospital

Abeokuta, Ogun State, Nigeria

RECRUITING

Neuropsychiatric Specialist Hospital

Akure, Ondo State, Nigeria

RECRUITING

Obafemi Awolowo University Teaching Hospital

Ile-Ife, Osun State, Nigeria

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Dried blood spots and dried breastmilk spots on protein saver cards

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Mania; Breast Feeding

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Adeniyi Olagunju, PhD

  University of Liverpool

  STUDY CHAIR

Central Study Contacts

Adeniyi Olagunju, BPharm MRes PhD

CONTACT

+44151 794 0418; olagunju@liverpool.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 13, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2025-02

Locations

NG (6)