Chicago, Illinois 60611


Purpose:

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 summary:

There is an increased risk of recurrence of Bipolar Disorder (BD) episodes or worsening symptoms in pregnancy after the discontinuation of mood stabilizers. Similarly, changes in medication concentration due to the physiological changes in pregnancy may effectively reduce the medication dose and thus its efficacy in pregnancy. Therapeutic dose monitoring has proven to have great utility in preventing seizure recurrence in women with epilepsy (WWE), specifically, dose monitoring of lamotrigine (LTG). Similar guidelines to that of women with epilepsy would benefit pregnant women with BD who are taking lamotrigine (LTG) in pregnancy. However, the pharmacokinetics as well as the utility of therapeutic dose monitoring of LTG in pregnant patients with Bipolar Disorder has not been well studied. This study is an observational protocol to explore the longitudinal pharmacokinetics (PK) of LTG during pregnancy and postpartum in 10 women with Bipolar Disorder. The correlation between changes in bioavailability and level-to-dose (L/D) ratios and increases in symptoms of depression, mania and anxiety and recurrence of syndromal BD episodes that fulfill Diagnostic and Statistics Manual of Mental Disorders (IV) (DSM4) criteria will be investigated. The primary aims of this study are 1.) To assess the impact of the dynamic physiology of pregnancy on the L/D ratio and bioavailability of LTG in women with BD. 2.) To evaluate the correlations between maternal and umbilical cord LTG serum levels. 3.) To explore the relationship between declining LTG L/D ratios during pregnancy, bioavailability and the increase in psychiatric symptoms and recurrence of syndromal BD. 4.) To explore the relationship between declining LTG L/D ratios during pregnancy, bioavailability and the recurrence of anxiety symptoms. Additionally this study will evaluate correlations between estradiol levels and change in LTG L/D ratios during pregnancy. To optimize the research yield from this investigation, participants will have the option to allow banking of cerebrospinal (CSF) fluid and DNA for future analyses.


Criteria:

Inclusion Criteria: - Age 18 or older - If Pregnant, equal to or less than 26 weeks - English-speaking - DSM-IV Bipolar Disorder, any subtype - Able to provide informed consent - Daily dosing of Lamictal Exclusion Criteria: - Active substance abuse within last 6 months and/or positive urine drug screen - Active suicidality - No obstetrical care - Antiepileptic drugs that affect metabolism of LTG - Medications in FDA categories F or X that are not antimanic drugs - Liver or kidney disease


NCT ID:

NCT01996293


Primary Contact:

Principal Investigator
Crystal T Clark, MD, MSc
Assistant Professor

Rebecca L Newmark, BA
Phone: 312-695-6010 ext. 56010
Email: rebecca.newmark@northwestern.edu


Backup Contact:

Email: crystal.clark@northwestern.edu
Crystal T Clark, MD, MSc
Phone: 312-695-8648


Location Contact:

Chicago, Illinois 60611
United States

Crystal T Clark, MD, MSc
Phone: 312-695-8648
Email: crystal.clark@northwestern.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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