Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Epilepsy Clinical Trial

Official title:

Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00612235
• Other study ID #: 2007P000357
• Status: Completed
• Start date: April 2008
• Est. completion date: June 2010

Study information

• Verified date: January 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Premenstrual Dysphoric Disorder

Intervention

Drug:
• Lamotrigine
Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.
• Levetiracetam
Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.
• Carbamazepine
Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.

Other:
• No Intervention
No intervention was given

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Newton-Wellesley Hospital	Newton	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital, Newton-Wellesley Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Herzog AG, Smithson SD, Fowler KM, Krishnamurthy KB, Sundstrom D, Kalayjian LA, Heck CN, Oviedo S, Correl-Leyva G, Garcia E, Gleason KA, Dworetzky BA. Premenstrual dysphoric disorder in women with epilepsy: relationships to potential epileptic, antiepileptic drug, and reproductive endocrine factors. Epilepsy Behav. 2011 Aug;21(4):391-6. doi: 10.1016/j.yebeh.2011.05.024. Epub 2011 Jul 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of PMDD Designation after two consecutive menstrual cycles
Primary	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.	Assessment of PMDD Designation after two consecutive menstrual cycles