This trial is active, not recruiting.

Conditions epilepsy, psychiatric or mood diseases or conditions
Sponsor North Shore Long Island Jewish Health System
Collaborator Epilepsy Foundation
Start date October 2010
End date April 2013
Trial size 200 participants
Trial identifier NCT01231646, 10-266A


Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional

Primary Outcomes

To examine association between levels of folate receptor autoantibodies and therapy (VPA, LTG) in women
time frame: n/a (cross-sectional study)

Eligibility Criteria

Female participants from 18 years up to 50 years old.

Inclusion Criteria: - Women ages 18-50 years inclusive who are taking valproate or lamotrigine for neurologic or psychiatric conditions - Valproate of lamotrigine must be used as monotherapy at stable doses for 6 weeks prior to the study for the neurologic or psychiatric illness; medications taken for other reasons are not excluded. Exclusion Criteria: - Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.

Additional Information

Official title Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?
Principal investigator Cynthia Harden, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by North Shore Long Island Jewish Health System.