Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Beth Israel Lahey Health

Status: Completed

Conditions: Epilepsy

Treatments: Drug: Lamotrigine; Other: No Intervention; Drug: Levetiracetam; Drug: Carbamazepine

Study type: Observational

Funder types: Other

Identifiers

NCT00612235

2007P000357

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

80 participants in 4 patient groups

Lamotrigine Monotherapy

Description:

Lamotrigine Monotherapy

Treatment:

Drug: Lamotrigine

Levetiracetam Monotherapy

Description:

Levetiracetam Monotherapy

Treatment:

Drug: Levetiracetam

Carbamazepine Monotherapy

Description:

Carbamazepine Monotherapy

Treatment:

Drug: Carbamazepine

Normal control (no epilepsy)

Description:

Normal control (no epilepsy)

Treatment:

Other: No Intervention