N/A N=80

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Epilepsy

Bottom Line

View on ClinicalTrials.gov: NCT00612235 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. — 0; 0; 0; 2 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Lamotrigine (Drug); Levetiracetam (Drug); Carbamazepine (Drug); No Intervention (Other)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Beth Israel Deaconess Medical Center
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.	0; 0; 0; 2; 2; 2	—
PRIMARY Proportion of Women With PMDD in WWE and the Control Group	0; 0; 6; 2; 54; 18	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00612235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.