NCT00612235

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lamotrigine	Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.
DRUG	Levetiracetam	Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.
DRUG	Carbamazepine	Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.
OTHER	No Intervention	No intervention was given

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-02-11
• Last updated: 2018-10-26
• Results posted: 2018-10-26

Locations

3 sites across 1 country: United States