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NCT02978534 · ClinicalTrials.gov registry record
Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 4
- Enrollment target
NCT02978534: Completed study, sponsored by Northwestern University.
NCT02978534 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02978534 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
Study Summary
The widespread and common use of quetiapine in childbearing and pregnant women demands more data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation Labeling Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior A, B, C, D, and X categories. Additionally, the PLLR will require information to aid prescribing decisions in three categories 1) Pregnancy (including labor and delivery), 2) Lactation, and 3) Females and Males of Reproductive Potential. The pregnancy category will include a subsection that will describe pharmacokinetic and pharmacodynamic characteristics of the medication in pregnancy, fetal risk, and data quality. The data collected in this study will update the FDA pregnancy pharmacokinetic section for quetiapine and inform physicians that prescribe to childbearing women.
Primary Outcome
For patients taking the immediate release formulation, plasma levels will be obtained beginning at time 0 and at hours, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16. For patients on the extended release formulation, plasma levels will be obtained at time 0 and at hours 0.5, 1, 1.5, 2, 2,5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, and 24.
Interventions
- DRUG Quetiapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-12 |
What the finished NCT02978534 record still lists
NCT02978534 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Quetiapine is the first listed.
NCT02978534 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02978534 about?
NCT02978534 is a clinical study titled "Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum". The widespread and common use of quetiapine in childbearing and pregnant women demands more data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation Labeling Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior A, B, C, D, and X categories. ...
What is the current status of trial NCT02978534?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2016-03. Estimated completion is 2020-12.
What interventions are being tested in trial NCT02978534?
The interventions under investigation include: Quetiapine (DRUG).
Who is sponsoring clinical trial NCT02978534?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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