Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Status:	Completed
Conditions:	Neurology, Women's Studies, Epilepsy
Therapuetic Areas:	Neurology, Other, Reproductive
Healthy:	No
Age Range:	18 - 45
Updated:	10/28/2018
Start Date:	April 2008
End Date:	June 2010

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.

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.

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

We found this trial at

sites

Newton-Wellesley Hospital

2014 Washington St
Newton, Massachusetts 02462

(617) 243-6000