Premenstrual Dysphoric Disorder and Antiepileptic Drugs

This study is currently recruiting participants.

Verified March 2010 by Beth Israel Deaconess Medical Center

First Received on January 29, 2008. Last Updated on March 15, 2010 History of Changes

Sponsor:	Beth Israel Deaconess Medical Center
Collaborators:	Newton-Wellesley Hospital Brigham and Women's Hospital
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00612235

Purpose

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.

Condition
Epilepsy

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Phenytoin Lamotrigine Levetiracetam Carbamazepine

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

To determine if the frequency of premenstrual dysphoric disorder differs among antiepileptic drug monotherapies. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

serum

Estimated Enrollment:	100
Study Start Date:	November 2007
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Lamotrigine Monotherapy
2 Levetiracetam Monotherapy
3 Carbamazepine Monotherapy
4 Phenytoin Monotherapy
5 Normal control (no epilepsy)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Three regional epilepsy centers

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612235

Contacts

Contact: Andrew G Herzog, MD	617 667 4523
Contact: Sarah D Smithson, BA	617 667 4523	ssmithso@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Andrew G Herzog, MD 617-667-4523
Contact: Sarah D Smithson, BA 617 667 4523 ssmithso@bidmc.harvard.edu
Principal Investigator: Andrew G Herzog, MD
Sub-Investigator: Kaarkuzhali Krishnamurthy, MD
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Sonia Replansky, BA 617-732-5423 sreplansky@partners.org
Principal Investigator: Barbara Dworetzky, MD
Newton-Wellesley Hospital	Recruiting
Newton, Massachusetts, United States, 02462
Contact: Eduardo Garcia, MD 617-969-1723 egarcia6@partners.org
Principal Investigator: Eduardo Garcia, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Newton-Wellesley Hospital

Brigham and Women's Hospital

Investigators

Principal Investigator:

Andrew G Herzog, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Andrew G. Herzog, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00612235 History of Changes
Other Study ID Numbers:	2007-P-000357/2
Study First Received:	January 29, 2008
Last Updated:	March 15, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

epilepsy
lamotrigine
levetiracetam
carbamazepine
phenytoin

lamictal
keppra
tegretol
carbatrol
dilantin

Additional relevant MeSH terms:

Epilepsy
Premenstrual Syndrome
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Menstruation Disturbances
Pathologic Processes
Etiracetam
Anticonvulsants
Carbamazepine
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Nootropic Agents

ClinicalTrials.gov processed this record on February 09, 2012