Epilepsy, Psychiatric or Mood Diseases or Conditions
Conditions
Keywords
Folate Receptor Autoantibodies, Epilepsy, Psychiatric conditions
Brief summary
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.
Interventions
OTHERNo intervention
No intervention. This is a cross-sectional study.
Sponsors
Epilepsy Foundation
Northwell Health
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Folate Receptor Autoantibodies | On the same day after informed consent was obtained | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lamotrigine Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate. | 28 |
| Valproate Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine. | 10 |
| Total | 38 |
Baseline characteristics
| Characteristic | Lamotrigine | Valproate | Total |
|---|---|---|---|
| Age, Continuous | 33 years STANDARD_DEVIATION 10.22 | 39.1 years STANDARD_DEVIATION 7.77 | 34.7 years STANDARD_DEVIATION 9.89 |
| BMI | 24.95 kg/m^2 STANDARD_DEVIATION 4.3 | 30.47 kg/m^2 STANDARD_DEVIATION 7.2 | 26.44 kg/m^2 STANDARD_DEVIATION 5.77 |
| Sex: Female, Male Female | 28 Participants | 10 Participants | 38 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Levels of Folate Receptor Autoantibodies
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.
Time frame: On the same day after informed consent was obtained
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lamotrigine | Levels of Folate Receptor Autoantibodies | Immunoglobulin G | 35.33 ug/mL | Standard Deviation 27.14 |
| Lamotrigine | Levels of Folate Receptor Autoantibodies | Immunoglobulin M | 44.3 ug/mL | Standard Deviation 34.18 |
| Lamotrigine | Levels of Folate Receptor Autoantibodies | Immunoglobulin G and Immunoglobulin M | 79.62 ug/mL | Standard Deviation 50.12 |
| Valproate | Levels of Folate Receptor Autoantibodies | Immunoglobulin G | 35.21 ug/mL | Standard Deviation 20.57 |
| Valproate | Levels of Folate Receptor Autoantibodies | Immunoglobulin M | 41.81 ug/mL | Standard Deviation 33.13 |
| Valproate | Levels of Folate Receptor Autoantibodies | Immunoglobulin G and Immunoglobulin M | 77.06 ug/mL | Standard Deviation 46 |