NCT00612235 - Premenstrual Dysphoric Disorder and Antiepileptic Drugs | Crick

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

80

Conditions

Epilepsy

Interventions

LamotrigineDRUG

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

LevetiracetamDRUG

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

CarbamazepineDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Newton-Wellesley Hospital

Newton, Massachusetts, United States

Outcomes

Primary Outcomes

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

Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria

Time frame: Assessment of PMDD Designation after two consecutive menstrual cycles

Proportion of Women With PMDD in WWE and the Control Group

Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria.

Time frame: Assessment of PMDD Designation after two consecutive menstrual cycles