Premenstrual Dysphoric Disorder and Antiepileptic Drugs
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ClinicalTrials.gov Identifier: NCT00612235 |
Recruitment Status
: Unknown
Verified March 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was: Recruiting
First Posted
: February 11, 2008
Last Update Posted
: March 16, 2010
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Condition or disease |
---|
Epilepsy |
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 |

Group/Cohort |
---|
1
Lamotrigine Monotherapy
|
2
Levetiracetam Monotherapy
|
3
Carbamazepine Monotherapy
|
4
Phenytoin Monotherapy
|
5
Normal control (no epilepsy)
|
- To determine if the frequency of premenstrual dysphoric disorder differs among antiepileptic drug monotherapies. [ Time Frame: 1 Year ]
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612235
Contact: Andrew G Herzog, MD | 617 667 4523 | ||
Contact: Sarah D Smithson, BA | 617 667 4523 | ssmithso@bidmc.harvard.edu |
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 |
Principal Investigator: | Andrew G Herzog, MD | Beth Israel Deaconess Medical Center |
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 Key Record Dates |
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 |