An observational study in Schizophrenia, Psychosis and Mania, sponsored by University of Liverpool. Completed at 6 sites in Nigeria. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by University of Liverpool · Observational
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.
Primary Objectives
Secondary Objectives
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's enrollment of 168 is close to the median of 178 across 506 observational studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.
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Pregnant and postpartum women, at least 18 years old receiving maintenance dose of long-acting injectable antipsychotics (LAIA).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant or breastfeeding women receiving the long acting injectable form of Risperidone and their babies
Pregnant or breastfeeding women receiving Paliperidone palmitate and their babies
Pregnant or breastfeeding women receiving the Flupentixol decanoate and their babies
Pregnant or breastfeeding women receiving the Zuclopenthixol decanoate and their babies
Pregnant or breastfeeding women receiving the Fluphenazine decanoate and their babies
Minimum plasma drug concentration (Cmin) during pregnancy and postpartum
Determined from sampling at the end of a dosing interval during pregnancy, and postpartum
Time frame: 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
Time frame: 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
Time frame: During gestation weeks 33-36 and weeks 9-12 weeks postpartum
Maximum breastmilk drug concentration (Cmin)
Highest concentration during a postpartum dosing interval
Time frame: During weeks 9-12 weeks postpartum
Area under the plasma concentration-time curve (AUC)
For assessment of overall drug exposure in plasma
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: As soon as possible after delivery
LAIA associated symptoms
To monitor LAIA side effects during and postpartum using the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS)
Time frame: From gestation week 28 to postpartum week 12
Clinical improvement
To monitor illness severity, improvement and LAIA efficacy during pregnancy and postpartum using the Clinical Global Impressions Scale.
Time frame: From gestation week 28 to postpartum week 12
Single nucleotide polymorphisms in drug disposition genes
To explore genetic sources of interindividual variability in maternal and fetal/breastfed infant drug exposure
Time frame: From gestation week 28 to postpartum week 12
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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University of Liverpool