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Premenstrual Dysphoric Disorder and Antiepileptic Drugs
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
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
First received: January 29, 2008
Last updated: March 15, 2010
Last verified: March 2010
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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
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 ]
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 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612235
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
| 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 |
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 |
ClinicalTrials.gov processed this record on August 17, 2017