Pregnant Women Taking Lamictal for Bipolar Disorder (PK-LAPB)
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|ClinicalTrials.gov Identifier: NCT01996293|
Recruitment Status : Recruiting
First Posted : November 27, 2013
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment|
|Bipolar Disorder||Drug: lamotrigine|
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.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women With Bipolar Disorder|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||September 2017|
Lamotrigine for Bipolar
antepartum and peripartum women taking lamotrigine for Bipolar Disorder
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 Name: Lamictal, Lamiktal, Labileno, Triazines
- Change in Serum concentration/elimination [ Time Frame: An average of every 10 weeks; Hours 0, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24, or 0, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 13.5, 14.5, and 16 ]For patients on 1x day dosing, serum levels will be obtained beginning at time 0 and at hours, 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 16, 20, 24 and L/D ratio will be determined at each time point. This series of serum levels will be completed an average of every 10 weeks across pregnancy, and postpartum. For patients on 2x dosing, serum levels will be obtained at hours 1, 2, 3, 3.5, 4, 5, 6, 7, 8, 10, 12, 13.5, 14.5, and 16 hours.
- Infant (umbilical cord)/Maternal ratio of LTG [ Time Frame: 30 min ]Ratio of umbilical cord (infant) LTG serum level to maternal LTG serum level will be determined at delivery.
- Scores on depression assessment, Inventory of Depression Symptomatology- Self Report (IDS-SR) [ Time Frame: Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum. ]To determine if there is a pattern of increasing scores on self-report depression assessment (IDS-SR) and declining L/D ratios. Increasing scores indicate worsening symptoms or depression episode recurrence.
- Scores on mania assessment, Young Mania Reporting Scale (YMRS) [ Time Frame: Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum. ]To determine if there is a pattern of increasing scores on clinician administered mania assessment (YMRS) and declining L/D ratios.
- Scores on anxiety scale, Generalized Anxiety Disorder (GAD-7) [ Time Frame: Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum. ]
- Percent increase in estradiol levels and their correlation to percent decrease in LTG L/D ratio [ Time Frame: Estradiol levels will be examined an average of every 10 weeks from the time the participant enters the study, up to 12 weeks postpartum. ]
Biospecimen Retention: Samples With DNA
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996293
|Contact: Rebecca L Newmark, BA||312-695-6010 ext firstname.lastname@example.org|
|Contact: Crystal T Clark, MD, MScemail@example.com|
|United States, Illinois|
|Northwestern Memorial Hospital||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Crystal T Clark, MD, MSc 312-695-8648 firstname.lastname@example.org|
|Principal Investigator: Crystal T Clark, MD, MSc|
|Principal Investigator:||Crystal T Clark, MD, MSc||Assistant Professor|