Premenstrual Dysphoric Disorder and Antiepileptic Drugs
Information source: Beth Israel Deaconess Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Phase: N/A
Status: Recruiting
Sponsored by: Beth Israel Deaconess Medical Center Official(s) and/or principal investigator(s): Andrew G Herzog, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center
Overall contact: Andrew G Herzog, MD, Phone: 617 667 4523
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.
Clinical Details
Official title: Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: To determine if the frequency of premenstrual dysphoric disorder differs among antiepileptic drug monotherapies.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): 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
Locations and Contacts
Andrew G Herzog, MD, Phone: 617 667 4523
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting Andrew G Herzog, MD, Phone: 617-667-4523 Sarah D Smithson, BA, Phone: 617 667 4523, Email: ssmithso@bidmc.harvard.edu Andrew G Herzog, MD, Principal Investigator Kaarkuzhali Krishnamurthy, MD, Sub-Investigator
Brigham and Women's Hospital, Boston, Massachusetts 02215, United States; Recruiting Sonia Replansky, BA, Phone: 617-732-5423, Email: sreplansky@partners.org Barbara Dworetzky, MD, Principal Investigator
Newton-Wellesley Hospital, Newton, Massachusetts 02462, United States; Recruiting Eduardo Garcia, MD, Phone: 617-969-1723, Email: egarcia6@partners.org Eduardo Garcia, MD, Principal Investigator
Additional Information
Starting date: November 2007
Last updated: March 15, 2010
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