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Completed

NCT Number: NCT01996293

Pregnant Women Taking Lamictal for 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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamotrigine

Drug

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 names: Lamictal, Lamiktal, Labileno, Triazines

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women With Bipolar Disorder

Acronym: PK-LAPB

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2013
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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