SchizophreniaLAMPNCT05766007
Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum
An observational study of Schizophrenia and Psychosis, run by University of Liverpool at 6 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Schizophrenia, Psychosis, Mania
- Type of treatment
- Injection or infusion
- How many people
- 168 participants
- Where
- 6 sitesNigeria
- Study dates
- 1 Aug 2023to 21 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant and postpartum women, at least 18 years old receiving maintenance dose of long-acting injectable antipsychotics (LAIA).
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Nigeria6 sites
Neuropsychiatric Hospital
Abeokuta, Ogun State
Neuropsychiatric Specialist Hospital
Akure, Ondo State
Obafemi Awolowo University Teaching Hospital
Ile-Ife, Osun State
Federal Neuropsychiatric Hospital
Kaduna, Kaduna State
Federal Medical Centre
Makurdi, Benue State
Federal Neuropsychiatric Hospital
Yaba, Lagos
About this study
Official title: Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum: An Observational Cohort Study
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.
Read more
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.
Read the detailed description
Primary Objectives
- 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.
- To describe breastmilk pharmacokinetics of selected LAIAs and the extent of breastfed infant exposure.
Secondary Objectives
- To assess safety and clinical outcomes following LAIA use during pregnancy and postpartum.
- To explore sources of variability in maternal and fetal/breastfed infant LAIA exposure.
- Conditions
- Schizophrenia, Psychosis, Mania, Pregnancy, Drug Exposure in Utero, Drug Exposure Via Breast Milk
- Keywords
- mental ill health, pregnancy, postpartum, long-acting injectable antipsychotics, Risperidone, Paliperidone palmitate, Fluphenazine decanoate, Flupentixol decanoate, Zuclopenthixol decanoate
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Mania, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum plasma drug concentration (Cmin) during pregnancy and postpartum
Determined from sampling at the end of a dosing interval during pregnancy, and postpartum
Measured: 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
Measured: 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
Measured: During gestation weeks 33-36 and weeks 9-12 weeks postpartum
Maximum breastmilk drug concentration (Cmin)
Highest concentration during a postpartum dosing interval
Measured: During weeks 9-12 weeks postpartum
Area under the plasma concentration-time curve (AUC)
For assessment of overall drug exposure in plasma
Measured: 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
Measured: 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
Measured: 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
Measured: As soon as possible after delivery
Secondary outcomes (3)
LAIA associated symptoms
To monitor LAIA side effects during and postpartum using the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS)
Measured: 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.
Measured: 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
Measured: From gestation week 28 to postpartum week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Aug 2023
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Neuropsychiatric Hospital, Yaba, Federal Neuropsychiatric Hospital, Kaduna, Neuropsychiatric Hospital, Abeokuta, Neuropsychiatric Specialist Hospital, Akure, Federal Medical Centre, Makurdi
- Responsible party
- Sponsor
- Investigators
- Adeniyi Olagunju, PhD, Study chair, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766007
- Sponsor's protocol ID
- UoL001749
- Acronym
- LAMP
- Status last verified
- Apr 2026
- First submitted
- 30 Jan 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-acting Injectable Antipsychotics for Mental Ill-Health in Pregnancy and Postpartum: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05766007
- Acronym / sponsor ID
- LAMP / UoL001749
- Conditions
- Schizophrenia, Psychosis, Mania, Pregnancy, Drug Exposure in Utero, Drug Exposure Via Breast Milk
- Keywords
- mental ill health, pregnancy, postpartum, long-acting injectable antipsychotics, Risperidone, Paliperidone palmitate, Fluphenazine decanoate, Flupentixol decanoate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Federal Neuropsychiatric Hospital, Yaba, Federal Neuropsychiatric Hospital, Kaduna, Neuropsychiatric Hospital, Abeokuta, Neuropsychiatric Specialist Hospital, Akure, Federal Medical Centre, Makurdi
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives
- 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.
- To describe breastmilk pharmacokinetics of selected LAIAs and the extent of breastfed infant exposure.
Secondary Objectives
- To assess safety and clinical outcomes following LAIA use during pregnancy and postpartum.
- To explore sources of variability in maternal and fetal/breastfed infant LAIA exposure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant and postpartum women, at least 18 years old receiving maintenance dose of long-acting injectable antipsychotics (LAIA).
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Minimum breastmilk drug concentration (Cmin)
Time frame: During weeks 9-12 weeks postpartum
Determined from sampling at the end of a postpartum dosing interval
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
Maximum breastmilk drug concentration (Cmin)
Time frame: During weeks 9-12 weeks postpartum
Highest concentration during a postpartum dosing interval
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
Area under the breastmilk concentration-time curve (AUC)
Time frame: During weeks 9-12 weeks postpartum
For assessment of overall drug exposure in breastmilk
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
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
3 secondary outcomes
LAIA associated symptoms
Time frame: From gestation week 28 to postpartum week 12
Clinical improvement
Time frame: From gestation week 28 to postpartum week 12
Single nucleotide polymorphisms in drug disposition genes
Time frame: From gestation week 28 to postpartum week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeniyi Olagunju, PhD study chair
University of Liverpool
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Psychosis, run by University of Liverpool at 6 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum plasma drug concentration (Cmin) during pregnancy and postpartum (time frame: During gestation weeks 33-36 and weeks 9-12 weeks postpartum). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.