Premenstrual Dysphoric Disorder and Antiepileptic Drugs
- Conditions
- Epilepsy
- Interventions
- Registration Number
- NCT00612235
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- 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
- Concomitant use of prescribed or OTC reproductive hormones
- Concomitant use of antidepressant and anxiolytic medications such as SSRIs, bupropion, tricyclics, benzodiazepines
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lamotrigine Monotherapy Lamotrigine Lamotrigine Monotherapy Normal control (no epilepsy) No Intervention Normal control (no epilepsy) Levetiracetam Monotherapy Levetiracetam Levetiracetam Monotherapy Carbamazepine Monotherapy Carbamazepine Carbamazepine Monotherapy
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Newton-Wellesley Hospital
🇺🇸Newton, Massachusetts, United States