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NCT01996293 · ClinicalTrials.gov registry record
Pregnant Women Taking Lamictal for Bipolar Disorder
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 30
- Enrollment target
NCT01996293: Completed study, sponsored by Northwestern University.
NCT01996293 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01996293 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during pregnancy for women with Bipolar Disorder. The investigators predict that the concentration of Lamictal in women's blood will decrease during pregnancy, and increase after postpartum. Because the concentration of the medication is likely to decrease during pregnancy, it is important for doctors to know how much they should increase a patient's dose in order to prevent worsening of Bipolar symptoms. In this study, the investigators will ask that participants complete up to five overnight visits to our clinical research unit where their blood will be drawn every couple of hours, through an IV catheter, to measure how the concentration of lamotrigine (Lamictal) changes over time. Participants will be compensated for their time.
Primary Outcome
For patients on 1x day dosing, serum levels will be obtained beginning at time 0 and at hours, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24 and L/D ratio will be determined at each time point. This series of serum levels will be completed an average of every 10 weeks across pregnancy, and postpartum. For patients on 2x dosing, serum levels will be obtained at hours 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 13.5, 14.5, and 16 hours.
Interventions
- DRUG lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-09 |
| Est. Completion | 2020-12 |
What the finished NCT01996293 record still lists
NCT01996293 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which lamotrigine is the first listed.
NCT01996293 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01996293 about?
NCT01996293 is a clinical study titled "Pregnant Women Taking Lamictal for Bipolar Disorder". This study seeks to examine how the dose of lamotrigine (Lamictal) should be adjusted during pregnancy for women with Bipolar Disorder. The investigators predict that the concentration of Lamictal in women's blood will decrease during pregnancy, and increase after postpartum. Because the concentrati...
What is the current status of trial NCT01996293?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2013-09. Estimated completion is 2020-12.
What interventions are being tested in trial NCT01996293?
The interventions under investigation include: lamotrigine (DRUG).
Who is sponsoring clinical trial NCT01996293?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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