CompletedNot Applicable

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

United States80 participantsStarted 2008-04

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.

Timeframe: Assessment of PMDD Designation after two consecutive menstrual cycles

Proportion of Women With PMDD in WWE and the Control Group

Timeframe: Assessment of PMDD Designation after two consecutive menstrual cycles

Trial details

NCT IDNCT00612235

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-06

Results submitted2017-03-16

View on ClinicalTrials.gov More Epilepsy trials