Pregnant Women Taking Lamictal for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

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.
    

Detailed description: 
      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.
    

Intervention name(s): lamotrigine
Intervention type(s): Drug
Intervention description(s): Lamotrigine will be observed in women who have already under the guidance of a physician decide to continue lamotrigine for the treatment of Bipolar Disorder
Other intervention name(s): Lamictal, Lamiktal, Labileno, Triazines
Intervention MeSH terms: Lamotrigine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited broadly from Northwestern clinical services including
        Internal Medicine, OB/GYN, Family Medicine, and Psychiatry, registries, and from the local
        Chicagoland community. Patients that sign consent, complete the evaluation and meet
        criteria for Bipolar Disorder, any subtype, will be enrolled into the study.
      
Biospecimen description: 
      Blood serum specimen will be obtained to measure lamotrigine and estradiol levels. Standard
      of care labs will be obtained on every participant that is eligible and signs informed
      consent. Participants will not have more than 50 ml of blood drawn every 8 weeks.
      Participants will also have the option to have blood drawn for DNA banking.

      Participants in the study that elect to receive analgesia for pain related to labor and have
      a spinal-epidural at Northwestern University will have CSF stored and banked for future
      analysis.
    
Keywords: pregnant; bipolar; lamotrigine; lamictal; women; female