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NCT00612235 · ClinicalTrials.gov registry record
Premenstrual Dysphoric Disorder and Antiepileptic Drugs
A clinical trial, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- 80
- Enrollment target
NCT00612235: Completed study, sponsored by Beth Israel Deaconess Medical Center.
NCT00612235 is a clinical trial that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00612235 has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
Study 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.
Primary Outcome
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 symp
Interventions
- OTHER No Intervention
- DRUG Lamotrigine
- DRUG Levetiracetam
- DRUG Carbamazepine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-06 |
What the finished NCT00612235 record still lists
NCT00612235 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which No Intervention is the first listed.
NCT00612235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00612235 about?
NCT00612235 is a clinical study titled "Premenstrual Dysphoric Disorder and Antiepileptic Drugs". 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.
What is the current status of trial NCT00612235?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2008-04. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00612235?
The interventions under investigation include: No Intervention (OTHER), Lamotrigine (DRUG), Levetiracetam (DRUG), Carbamazepine (DRUG).
Who is sponsoring clinical trial NCT00612235?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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