Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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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

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lamotrigine Monotherapy

Lamotrigine

Intervention Type DRUG

Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.

Levetiracetam Monotherapy

Levetiracetam

Intervention Type DRUG

Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.

Carbamazepine Monotherapy

Carbamazepine

Intervention Type DRUG

Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.

Normal control (no epilepsy)

No Intervention

Intervention Type OTHER

No intervention was given

Interventions

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Lamotrigine

Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.

Intervention Type DRUG

Levetiracetam

Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.

Intervention Type DRUG

Carbamazepine

Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.

Intervention Type DRUG

No Intervention

No intervention was given

Intervention Type OTHER

Other Intervention Names

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Lamictal Keppra Tegretol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes