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

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 49
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Nigeria
Neuropsychiatric Hospital
RECRUITING
Abeokuta
Neuropsychiatric Specialist Hospital
RECRUITING
Akure
Obafemi Awolowo University Teaching Hospital
NOT_YET_RECRUITING
Ile-ife
Federal Neuropsychiatric Hospital
RECRUITING
Kaduna
Federal Medical Centre
RECRUITING
Makurdi
Federal Neuropsychiatric Hospital
RECRUITING
Yaba
Contact Information
Primary
Adeniyi Olagunju, BPharm MRes PhD
olagunju@liverpool.ac.uk
+44151 794 0418
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 125
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Federal Neuropsychiatric Hospital, Kaduna, Federal Medical Centre, Makurdi, Federal Neuropsychiatric Hospital, Yaba, Obafemi Awolowo University Teaching Hospital, Neuropsychiatric Specialist Hospital, Akure, Neuropsychiatric Hospital, Abeokuta
Leads: University of Liverpool

This content was sourced from clinicaltrials.gov

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