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NCT02490241 · ClinicalTrials.gov registry record
Lithium Therapy: Understanding Mothers, Metabolism and Mood
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 9
- Enrollment target
NCT02490241 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 9 participants.
The verdict
NCT02490241 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 9 participants
- Enrollment target
Study Summary
Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation to medication therapy for Major Depression, is commonly continued in pregnancy due to its therapeutic benefit and more recent data that suggests the teratogenic effects of lithium are less than historically believed. Due to the increased elimination of lithium during pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the risk for postpartum exacerbation of BD and psychosis. Our study will investigate the pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum. Twenty women taking lithium in pregnancy or planning to become pregnant and continue lithium will be invited to participate in a study to measure repeated blood levels of lithium at six time points between preconception and 3 months postpartum. The data collected will inform the dose, timing of dose, and frequency of dosing of lithium that will lead to fewer untoward effects for the mother and baby. Change in elimination clearance of lithium will be correlated with symptom worsening to develop a dosing algorithm that will help maintain wellness for pregnant women with mood disorders.
Interventions
- DRUG Lithium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2015-04 |
| Est. Completion | 2020-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02490241
The ClinicalTrials.gov registry entry for NCT02490241 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lithium is the first listed.
NCT02490241 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02490241 about?
NCT02490241 is a clinical study titled "Lithium Therapy: Understanding Mothers, Metabolism and Mood". Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation to medication therapy for Major Depression, is commonly continued in pregnancy due to its therapeutic benefit and more recent data that suggests the teratogenic effects of lithium are less than historically b...
What is the current status of trial NCT02490241?
This trial is currently completed. The enrollment target is 9 participants. The study started on 2015-04. Estimated completion is 2020-06.
What interventions are being tested in trial NCT02490241?
The interventions under investigation include: Lithium (DRUG).
Who is sponsoring clinical trial NCT02490241?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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