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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

Page last updated: August 23, 2015

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