Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Epilepsy Foundation
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01231646
First received: October 28, 2010
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition
Epilepsy
Psychiatric or Mood Diseases or Conditions

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • To examine association between levels of folate receptor autoantibodies and therapy (VPA, LTG) in women [ Time Frame: n/a (cross-sectional study) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2010
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lamotrigine
Valproate

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in epilepsy and/or psychiatric clinics

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231646

Locations
United States, New York
North Shore Long Island Jewish Health System
Great Neck, New York, United States, 11021
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Epilepsy Foundation
Investigators
Principal Investigator: Cynthia Harden, MD North Shore-Long Island Jewish Medical Center
  More Information

No publications provided

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01231646     History of Changes
Other Study ID Numbers: 10-266A
Study First Received: October 28, 2010
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Folate Receptor Autoantibodies
Epilepsy
Psychiatric conditions

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014