Status:
COMPLETED
A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Bipolar Disorder
Major Depressive Disorder
Eligibility:
FEMALE
18+ years
Brief 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 Dru...
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 moo...
Eligibility Criteria
Inclusion
- 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
- suicidal/clinically unstable
- alcohol, marijuana, or other drug dependence in last 90 days
Key Trial Info
Start Date :
December 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 16 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03774641
Start Date
December 3 2018
End Date
April 16 2024
Last Update
March 5 2025
Active Locations (1)
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1
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Baltimore, Maryland, United States, 21205