CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Lamictaldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03774641
NCT03774641N/ACompleted
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A Pilot Study of Prophylactic Management of Lamotrigine for Bipolar Disorder in Pregnant Women

Johns Hopkins University·observational·Posted Dec 13, 2018·Updated Mar 5, 2025

In Brief

An observational study evaluating Lamictal for Bipolar Disorder and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder, Major Depressive Disorder, Schizo Affective Disorder
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 13, 2018
Enrollment StartDec 3, 2018
Primary CompletionApr 16, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 7.6 years ago

Interventions

Lamictaldrug

Blood-serum levels will be checked monthly during pregnancy and reference concentration will be maintained