Purpose

Pregnant women who are taking lamotrigine will be evaluated monthly during pregnancy including a clinical evaluation and a blood draw for lamotrigine levels at each visit. Based on the Therapeutic Drug Monitoring protocol, participant's lamotrigine dosing will be adjusted as needed based on participant's blood levels compared to the reference concentration that was obtained prior to pregnancy or early in pregnancy while clinically stable. After delivery participant and participant's infants will be assessed for mood and functioning at 1, 2, 4, and 6 weeks postpartum.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • pregnant, prior or 20 weeks - currently taking Lamotrigine and plan to continue throughout pregnancy - history of Bipolar Disorder, Major Depressive Disorder, Schizoaffective Disorder or other psychiatric illness, currently stable - may be taking other psychiatric medications

Exclusion Criteria

  • suicidal/clinically unstable - alcohol, marijuana, or other drug dependence in last 90 days

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Taking Lamotrigine Lamotrigine (Lamictal), dosage will be based on a reference concentration of blood-serum levels
  • Drug: Lamictal
    Blood-serum levels will be checked monthly during pregnancy and reference concentration will be maintained
    Other names:
    • Lamotrigine

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Kelsey Hannan
(443)583-4329
khannan1@jhmi.edu

Detailed Description

Studies have demonstrated that at least 80% of women who stop mood stabilizing medications for pregnancy relapse psychiatrically. However, relapse is also quite common in women who continue taking mood stabilizing medication with studies demonstrating approximately a 30-37% relapse rate-most with depressive episodes. One likely explanation for the high relapse rate of Bipolar Disorder during pregnancy despite continued mood stabilizing medication is decreasing blood levels of mood stabilizing medications during the course of pregnancy. Pregnancy induces both pharmacokinetic and pharmacodynamic changes, which can result in decreased serum blood levels and decreased treatment efficacy. Therapeutic drug monitoring is considered standard of care for a number of psychiatric medications. Therapeutic drug monitoring can be an especially crucial guide to clinical treatment during pregnancy, but remarkably, there are no established protocols for the monitoring of levels and dosing of psychiatric medications in pregnancy. Most pregnant psychiatric patients are therefore managed based on symptom recurrence. In contrast, there are established protocols for monitoring blood levels and prophylactic management of antiepileptic medications for epilepsy, including lamotrigine which is also a mood stabilizing medication. The investigators will collect pilot data on the psychiatric outcomes, adverse events, and obstetrical and infant outcomes of pregnant women with Bipolar Disorder who undergo prophylactic therapeutic drug monitoring for a commonly used mood stabilizing medication during pregnancy- lamotrigine. In the epilepsy literature, there is a published protocol for lamotrigine management before, during, and after pregnancy for seizure control; the investigators will use this protocol as a guide.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.