Pregnant Women Taking Lamictal for Bipolar Disorder

ClinicalTrials.gov ID: NCT01996293

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Official title

Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women With Bipolar Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01996293
Recruitment status: Completed
Study type: Observational
Phase: Not listed
Lead sponsor: Northwestern University; Other
Enrollment: 30 participants

Conditions and interventions

Conditions

Bipolar Disorder

Interventions

lamotrigine Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 45 Years
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2013 (Type not available)
Primary completion: Aug 2020 (Actual)
Completion: Dec 2020 (Actual)
Last update posted: Sep 28, 2022

2013 – 2020

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Northwestern Memorial Hospital	Chicago	Illinois	60611	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01996293, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 28, 2022 · Synced Nov 14, 2026