Pregnant Women Taking Lamictal for Bipolar Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | September 2017 |
| Contact: | Rebecca L Newmark, BA |
| Email: | rebecca.newmark@northwestern.edu |
| Phone: | 312-695-6010 |
Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women With 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 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.
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.
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.
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.
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
We found this trial at
1
site
251 E Huron St
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 926-2000
Principal Investigator: Crystal T Clark, MD, MSc
Phone: 312-695-8648
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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