Long-acting injectable antipsychotics for mental health during pregnancy and postpartum
Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum: An Observational Cohort Study
This study looks at how long-acting injectable antipsychotic medications affect pregnant and postpartum women, their unborn babies, and breastfeeding infants to see if they are safe during this time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | University of Liverpool Academic / other |
| Locations | 6 sites (Makurdi, Benue State and 5 other locations) |
| Trial ID | NCT05766007 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how long-acting injectable antipsychotic medications are influenced by physiological changes during pregnancy and their effects on unborn babies. It will also assess the transfer of these medications into breastmilk and the exposure of breastfeeding infants. Participants will undergo regular clinic visits for injections and additional study visits to collect blood and breastmilk samples for analysis. The study focuses on understanding pharmacokinetics and safety outcomes related to these medications in pregnant and postpartum women.
Who should consider this trial
Good fit: Ideal candidates include pregnant or breastfeeding women diagnosed with schizophrenia, mania, or other psychoses who are prescribed long-acting injectable antipsychotics.
Not a fit: Patients who are not currently pregnant or breastfeeding, or those with severe pregnancy-related complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safety and pharmacokinetics of antipsychotic medications during pregnancy and breastfeeding, potentially improving treatment protocols for affected women.
How similar studies have performed: While there is limited data on this specific approach, similar studies have explored pharmacokinetics in pregnancy, indicating potential for valuable findings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Makurdi, Benue State and 5 other locations
- Federal Medical Centre — Makurdi, Benue State, Nigeria (Recruiting)
- Federal Neuropsychiatric Hospital — Kaduna, Kaduna State, Nigeria (Recruiting)
- Federal Neuropsychiatric Hospital — Yaba, Lagos State, 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)
Study contacts
- Study coordinator: Adeniyi Olagunju, BPharm MRes PhD
- Email: olagunju@liverpool.ac.uk
- Phone: +44151 794 0418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.