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Premenstrual Dysphoric Disorder and Antiepileptic Drugs
This study is currenly Recruiting patients.
Sponsored by:
Beth Israel Deaconess Medical Center
Purpose
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: Treatment
| Condition | Treatment | Phase |
|
Epilepsy |
None | N/A |
Study Design:Observational Model: Cohort, Time Perspective: Prospective
Official Title: Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy
Further Study Details:
Expected Total Enrollment:
Study Dates:November 2007 -
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.
Eligibility
Ages Eligible for Study- Min: 18 Years Max: 45 Years
Gender: Female
Criteria
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
Inclusion Criteria:
months) AED monotherapies: LTG, CBZ, PHT or LEV and with documented therapeutic
range serum AED level during the year prior to enrollment.
Exclusion Criteria:
bupropion, tricyclics, benzodiazepines
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier: NCT00612235
Massachusetts
Beth Israel Deaconess Medical Center - Boston, Massachusetts 02215
Brigham and Women's Hospital - Boston, Massachusetts 02215
Sonia Replansky, BA 617-732-5423 sreplansky@partners.org
Newton-Wellesley Hospital - Newton, Massachusetts 02462
Eduardo Garcia, MD 617-969-1723 egarcia6@partners.org
More Information
Record Last Reviewed:March 2010
Last Updated:March 15, 2010
Record First Recieved:January 29, 2008
ClinicalTrials.gov Identifier:NCT00612235
Health Authority: United States Food and Drug Administration
Information obtained from ClinicalTrials.gov on September 02, 2010
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