Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease
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.

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Estimated Enrollment :	100 participants
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
Study Start Date :	November 2007
Estimated Primary Completion Date :	February 2010
Estimated Study Completion Date :	February 2010

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
1; Lamotrigine Monotherapy
2; Levetiracetam Monotherapy
3; Carbamazepine Monotherapy
4; Phenytoin Monotherapy
5; Normal control (no epilepsy)

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To determine if the frequency of premenstrual dysphoric disorder differs among antiepileptic drug monotherapies. [ Time Frame: 1 Year ]

Biospecimen Retention:   Samples Without DNA

serum

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes 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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	February 11, 2008
Last Update Posted:	March 16, 2010
Last Verified:	March 2010

Keywords provided by Beth Israel Deaconess Medical Center:

epilepsy; lamotrigine; levetiracetam; carbamazepine; phenytoin	lamictal; keppra; tegretol; carbatrol; dilantin

Additional relevant MeSH terms:

Epilepsy; Premenstrual Dysphoric Disorder; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Premenstrual Syndrome; Menstruation Disturbances; Pathologic Processes; Depressive Disorder; Mood Disorders; Mental Disorders; Lamotrigine; Carbamazepine; Anticonvulsants; Calcium Channel Blockers

Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Antimanic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents