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

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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: February 2009

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.

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Lamotrigine Monotherapy
• : 2
  • Levetiracetam Monotherapy
• : 3
  • Carbamazepine Monotherapy
• : 4
  • Phenytoin Monotherapy
• : 5
  • Normal control (no epilepsy)

Primary Measures

• To determine if the frequency of premenstrual dysphoric disorder differs among antiepileptic drug monotherapies.
  • Time Frame: 1 Year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Beth Israel Deaconess Medical Center

Overall Clinical Trial Officials and Contacts

Andrew G Herzog, MD Principal Investigator Beth Israel Deaconess Medical Center  

Overall Contact: Andrew G Herzog, MD 617 667 4523 

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612235

Study ID Number: 2007-P-000357/2

ClinicalTrials.gov Identifier: NCT00612235

Health Authority: United States: Institutional Review Board