Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
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
History of Changes
  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:

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   (Adult)
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
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

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
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:
Menstruation Disturbances
Epilepsy
Premenstrual Dysphoric Disorder
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Premenstrual Syndrome
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 September 27, 2016