Epilepsy
Conditions
Keywords
epilepsy, lamotrigine, levetiracetam, carbamazepine, phenytoin, lamictal, keppra, tegretol, carbatrol, dilantin
Brief summary
This study is being done to determine if there are differences in mood during the menstrual cycle among women with epilepsy who take various different antiepileptic drugs and women without epilepsy.
Detailed description
Participants will be given informed consent during the initial study visit. We will gather information about their seizure disorder and medications and provide them with instructions and a form that they will complete daily for two months (two menstrual cycles). During the third week of each menstrual cycle, they will be asked to return once to provide a blood sample.
Interventions
DRUGLamotrigine
Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.
DRUGLevetiracetam
Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.
DRUGCarbamazepine
Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.
OTHERNo Intervention
No intervention was given
Sponsors
Newton-Wellesley Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with epilepsy, 18-45 years of age. Women will be on one of 4 established (≥ 3 months) AED monotherapies: LTG, CBZ, PHT or LEV and with documented therapeutic range serum AED level during the year prior to enrollment. * Normal Control women, 18-45 years of age, in good general health by history
Exclusion criteria
* Concomitant use of prescribed or OTC reproductive hormones * Concomitant use of antidepressant and anxiolytic medications such as SSRIs, bupropion, tricyclics, benzodiazepines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | Assessment of PMDD Designation after two consecutive menstrual cycles | Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria |
| Proportion of Women With PMDD in WWE and the Control Group | Assessment of PMDD Designation after two consecutive menstrual cycles | Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria. |
Countries
United States
Participant flow
Recruitment details
The 3 participating sites enrolled 60 women with epilepsy, 20 in each of the 3 antiepileptic drug groups, and 20 normal controls between 4/1/2008 and 3/31/2010. All of the women met inclusion and exclusion criteria. No enrolled subject was excluded after enrollment.
Pre-assignment details
Since the original conceptualization of the study, phenytoin use declined among women with epilepsy in the general population to the point that we did not identify a sufficient base population in our initial screen to proceed with enrollment of this group and the decision was made at the start of the study to exclude this drug group.
Participants by arm
| Arm | Count |
|---|---|
| 1 Lamotrigine Monotherapy Women with Epilepsy on Lamotrigine Monotherapy | 20 |
| 2 Levetiracetam Monotherapy Women with Epilepsy on Levetiracetam Monotherapy | 20 |
| 3 Carbamazepine Monotherapy Women with Epilepsy on Carbamazepine Monotherapy | 20 |
| 5 Normal Control Normal Control Women(no epilepsy) | 20 |
| Total | 80 |
Baseline characteristics
| Characteristic | 2 Levetiracetam Monotherapy | 3 Carbamazepine Monotherapy | 1 Lamotrigine Monotherapy | 5 Normal Control | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 80 Participants |
| Age, Continuous | 33.08 years STANDARD_DEVIATION 7.57 | 29.93 years STANDARD_DEVIATION 8.74 | 32.44 years STANDARD_DEVIATION 8.06 | 31.79 years STANDARD_DEVIATION 8.21 | 31.75 years STANDARD_DEVIATION 8.22 |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 20 Participants | 20 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
Proportion of Women With PMDD in WWE and the Control Group
Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria.
Time frame: Assessment of PMDD Designation after two consecutive menstrual cycles
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3 Carbamazepine Monotherapy | Proportion of Women With PMDD in WWE and the Control Group | Endicott PMDD Designation | 0 Participants |
| 3 Carbamazepine Monotherapy | Proportion of Women With PMDD in WWE and the Control Group | Less Stringent Threshold for PMDD Designation | 6 Participants |
| 3 Carbamazepine Monotherapy | Proportion of Women With PMDD in WWE and the Control Group | No PMDD Designation | 54 Participants |
| 2 Levetiracetam Monotherapy | Proportion of Women With PMDD in WWE and the Control Group | Endicott PMDD Designation | 0 Participants |
| 2 Levetiracetam Monotherapy | Proportion of Women With PMDD in WWE and the Control Group | Less Stringent Threshold for PMDD Designation | 2 Participants |
| 2 Levetiracetam Monotherapy | Proportion of Women With PMDD in WWE and the Control Group | No PMDD Designation | 18 Participants |
Primary
To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.
Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria
Time frame: Assessment of PMDD Designation after two consecutive menstrual cycles
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3 Carbamazepine Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | Less Stringent Threshold for PMDD Designation | 2 Participants |
| 3 Carbamazepine Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | Endicott PMDD Designation | 0 Participants |
| 3 Carbamazepine Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | No PMDD Designation | 18 Participants |
| 2 Levetiracetam Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | Less Stringent Threshold for PMDD Designation | 2 Participants |
| 2 Levetiracetam Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | Endicott PMDD Designation | 0 Participants |
| 2 Levetiracetam Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | No PMDD Designation | 18 Participants |
| 1 Lamotrigine Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | Endicott PMDD Designation | 0 Participants |
| 1 Lamotrigine Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | No PMDD Designation | 18 Participants |
| 1 Lamotrigine Monotherapy | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | Less Stringent Threshold for PMDD Designation | 2 Participants |