Status:
COMPLETED
Premenstrual Dysphoric Disorder and Antiepileptic Drugs
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Newton-Wellesley Hospital
Brigham and Women's Hospital
Conditions:
Epilepsy
Eligibility:
FEMALE
18-45 years
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 t...
Eligibility Criteria
Inclusion
- 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
- Concomitant use of prescribed or OTC reproductive hormones
- Concomitant use of antidepressant and anxiolytic medications such as SSRIs, bupropion, tricyclics, benzodiazepines
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00612235
Start Date
April 1 2008
End Date
June 1 2010
Last Update
October 26 2018
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
3
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462