Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

This study has been completed.
Sponsor:
Collaborator:
Epilepsy Foundation
Information provided by (Responsible Party):
Northwell Health
ClinicalTrials.gov Identifier:
NCT01231646
First received: October 28, 2010
Last updated: October 23, 2015
Last verified: October 2015
  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 Intervention
Epilepsy
Psychiatric or Mood Diseases or Conditions
Other: No intervention

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 Northwell Health:

Primary Outcome Measures:
  • Levels of Folate Receptor Autoantibodies [ Time Frame: On the same day after informed consent was obtained ] [ Designated as safety issue: No ]
    ELISA assays using immobilized folate receptor protein were performed to determine the titers of immunoglobulin G, immunoglobulin M, and combined immunoglobulin G and immunoglobulin M to folate receptor in serum samples collected from both groups of women.


Enrollment: 38
Study Start Date: October 2010
Study Completion Date: July 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lamotrigine
No intervention
Other: No intervention
No intervention. This is a cross-sectional study.
Valproate
No intervention
Other: No intervention
No intervention. This is a cross-sectional study.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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
Northwell Health
Epilepsy Foundation
Investigators
Principal Investigator: Cynthia Harden, MD North Shore-Long Island Jewish Medical Center
  More Information

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01231646     History of Changes
Other Study ID Numbers: 10-266A 
Study First Received: October 28, 2010
Results First Received: August 24, 2015
Last Updated: October 23, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Northwell Health:
Folate Receptor Autoantibodies
Epilepsy
Psychiatric conditions

Additional relevant MeSH terms:
Disease
Epilepsy
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Folic Acid
Valproic Acid
Autoantibodies
Hematinics
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Immunologic Factors

ClinicalTrials.gov processed this record on August 23, 2016