N/A
Completed N=80
Premenstrual Dysphoric Disorder and Antiepileptic Drugs
Source: ClinicalTrials.gov NCT00612235 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. — 0; 0; 0; 2 Participants
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.
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 | — |
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
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. Informational only — not medical advice.