Premenstrual Dysphoric Disorder and Antiepileptic Drugs

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00612235
• Date of registration: 29/01/2008
• Primary sponsor: Beth Israel Deaconess Medical Center
• Public title: Premenstrual Dysphoric Disorder and Antiepileptic Drugs
• Scientific title: Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy
• Date of first enrolment: November 2007
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00612235
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Andrew G Herzog, MD

• Name: Andrew G Herzog, MD
• Affiliation: Beth Israel Deaconess Medical Center

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Epilepsy

Primary Outcome(s)

To determine if the frequency of premenstrual dysphoric disorder differs among antiepileptic drug monotherapies. [Time Frame: 1 Year]

Secondary ID(s)

2007-P-000357/2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Brigham and Women's Hospital

Newton-Wellesley Hospital