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| Name | Class |
|---|---|
| Federal Neuropsychiatric Hospital, Yaba | UNKNOWN |
| Federal Neuropsychiatric Hospital, Kaduna | UNKNOWN |
| Neuropsychiatric Hospital, Abeokuta | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| LAIA associated symptoms | To monitor LAIA side effects during and postpartum using the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) | From gestation week 28 to postpartum week 12 |
| Clinical improvement |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant and postpartum women, at least 18 years old receiving maintenance dose of long-acting injectable antipsychotics (LAIA).
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| Name | Affiliation | Role |
|---|---|---|
| Adeniyi Olagunju, PhD | University of Liverpool | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal Medical Centre | Makurdi | Benue State | Nigeria | |||
| Federal Neuropsychiatric Hospital |
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| Neuropsychiatric Specialist Hospital, Akure |
| UNKNOWN |
| Federal Medical Centre, Makurdi | UNKNOWN |
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Dried blood spots and dried breastmilk spots on protein saver cards
| 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 |
To monitor illness severity, improvement and LAIA efficacy during pregnancy and postpartum using the Clinical Global Impressions Scale.
| 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 | From gestation week 28 to postpartum week 12 |
| Kaduna |
| Kaduna State |
| Nigeria |
| Federal Neuropsychiatric Hospital | Yaba | Lagos | Nigeria |
| Neuropsychiatric Hospital | Abeokuta | Ogun State | Nigeria |
| Neuropsychiatric Specialist Hospital | Akure | Ondo State | Nigeria |
| Obafemi Awolowo University Teaching Hospital | Ile-Ife | Osun State | Nigeria |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D000087122 | Mania |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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