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Premenstrual Dysphoric Disorder and Antiepileptic Drugs

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ClinicalTrials.gov Identifier: NCT00612235
Recruitment Status : Completed
First Posted : February 11, 2008
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborators:
Newton-Wellesley Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center

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 Intervention/treatment
Epilepsy Drug: Lamotrigine Drug: Levetiracetam Drug: Carbamazepine Other: No Intervention

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 Type : Observational
Actual Enrollment : 80 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 : April 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010


Group/Cohort Intervention/treatment
Lamotrigine Monotherapy
Lamotrigine Monotherapy
Drug: Lamotrigine
Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.
Other Name: Lamictal

Levetiracetam Monotherapy
Levetiracetam Monotherapy
Drug: Levetiracetam
Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.
Other Name: Keppra

Carbamazepine Monotherapy
Carbamazepine Monotherapy
Drug: Carbamazepine
Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.
Other Name: Tegretol

Normal control (no epilepsy)
Normal control (no epilepsy)
Other: No Intervention
No intervention was given




Primary Outcome Measures :
  1. To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. [ Time Frame: Assessment of PMDD Designation after two consecutive menstrual cycles ]
    Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria

  2. Proportion of Women With PMDD in WWE and the Control Group [ Time Frame: Assessment of PMDD Designation after two consecutive menstrual cycles ]
    Proportion of women who meet the Endicott Daily Record of Severity of Problems (DRSP) criteria for PMDD for two consecutive menstrual cycles in women with epilepsy and the control group (no epilepsy). To meet PMDD designation, women must have reached the PMDD criteria for both menstrual cycles. The less stringent threshold for PMDD designation referred to (1) having more severe symptoms during the premenstrual phase than during the midfollicular phase regardless of whether the midfollicular symptom scores exceeded the Endicott cutoff and (2) meeting the other three Endicott criteria.


Biospecimen Retention:   Samples Without DNA
serum


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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
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

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
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

Publications:
Responsible Party: Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00612235     History of Changes
Other Study ID Numbers: 2007P000357
First Posted: February 11, 2008    Key Record Dates
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018
Last Verified: January 2018

Keywords provided by Andrew Herzog, 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
Etiracetam
Lamotrigine
Anticonvulsants
Carbamazepine
Piracetam
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Antimanic Agents
Tranquilizing Agents