Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Drug: Lamotrigine
* Drug: Levetiracetam
* Drug: Carbamazepine
* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lamotrigine Monotherapy<br>Lamotrigine Monotherapy | Drug: Lamotrigine<br>* Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.<br>* Other names: Lamictal;|
| Levetiracetam Monotherapy<br>Levetiracetam Monotherapy | Drug: Levetiracetam<br>* Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.<br>* Other names: Keppra;|
| Carbamazepine Monotherapy<br>Carbamazepine Monotherapy | Drug: Carbamazepine<br>* Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.<br>* Other names: Tegretol;|
| Normal control (no epilepsy)<br>Normal control (no epilepsy) | Other: No Intervention<br>* No intervention was given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Assessment of PMDD Designation after two consecutive menstrual cycles | 
| 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. | Assessment of PMDD Designation after two consecutive menstrual cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, lamotrigine, levetiracetam, carbamazepine, phenytoin, lamictal, keppra, tegretol, carbatrol, dilantin