A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women

Completed

Conditions studied: Bipolar Disorder, Major Depressive Disorder, Schizo Affective Disorder

In brief

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.

Key facts

Study ID

NCT03774641

Run by

Johns Hopkins University

People needed

10

Starts

2018-12-03

Expected to finish

2024-04-16

Last updated by the study team

2025-03-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• 550 N Broadway — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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