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| Name | Class |
|---|---|
| Newton-Wellesley Hospital | OTHER |
| Brigham and Women's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamotrigine Monotherapy | Lamotrigine Monotherapy |
| |
| Levetiracetam Monotherapy | Levetiracetam Monotherapy |
| |
| Carbamazepine Monotherapy | Carbamazepine Monotherapy |
| |
| Normal control (no epilepsy) | Normal control (no epilepsy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamotrigine | Drug | Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | 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 | Assessment of PMDD Designation after two consecutive menstrual cycles |
| Proportion of Women With PMDD in WWE and the Control Group | 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. | Assessment of PMDD Designation after two consecutive menstrual cycles |
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Inclusion Criteria:
Exclusion Criteria:
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Three regional epilepsy centers
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| Name | Affiliation | Role |
|---|---|---|
| Andrew G Herzog, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21724471 | Background | Herzog AG, Smithson SD, Fowler KM, Krishnamurthy KB, Sundstrom D, Kalayjian LA, Heck CN, Oviedo S, Correl-Leyva G, Garcia E, Gleason KA, Dworetzky BA. Premenstrual dysphoric disorder in women with epilepsy: relationships to potential epileptic, antiepileptic drug, and reproductive endocrine factors. Epilepsy Behav. 2011 Aug;21(4):391-6. doi: 10.1016/j.yebeh.2011.05.024. Epub 2011 Jul 2. |
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Since the original conceptualization of the study, phenytoin use declined among women with epilepsy in the general population to the point that we did not identify a sufficient base population in our initial screen to proceed with enrollment of this group and the decision was made at the start of the study to exclude this drug group.
The 3 participating sites enrolled 60 women with epilepsy, 20 in each of the 3 antiepileptic drug groups, and 20 normal controls between 4/1/2008 and 3/31/2010. All of the women met inclusion and exclusion criteria. No enrolled subject was excluded after enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1 Lamotrigine Monotherapy | Women with Epilepsy on Lamotrigine Monotherapy |
| FG001 | 2 Levetiracetam Monotherapy | Women with Epilepsy on Levetiracetam Monotherapy |
| FG002 | 3 Carbamazepine Monotherapy | Women with Epilepsy on Carbamazepine Monotherapy |
| FG003 | 5 Normal Control | Normal Control Women(no epilepsy) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Women with epilepsy on antiepileptic drug monotherapies and normal controls. There was no difference in the number who started and completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1 Lamotrigine Monotherapy | Women with Epilepsy on Lamotrigine Monotherapy |
| BG001 | 2 Levetiracetam Monotherapy | Women with Epilepsy on Levetiracetam Monotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies. | 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 | Posted | Count of Participants | Participants | Assessment of PMDD Designation after two consecutive menstrual cycles |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lamotrigine | Women with Epilepsy on Lamotrigine Monotherapy | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew G. Herzog M.D., M.Sc. | Beth Israel Deaconess Medical Center | 781-431-0277 | aherzog@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077213 | Lamotrigine |
| D000077287 | Levetiracetam |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000081 | Acetamides |
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serum
| Levetiracetam | Drug | Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy. |
|
|
| Carbamazepine | Drug | Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy. |
|
|
| No Intervention | Other | No intervention was given |
|
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| BG002 | 3 Carbamazepine Monotherapy | Women with Epilepsy on Carbamazepine Monotherapy |
| BG003 | 5 Normal Control | Normal Control Women(no epilepsy) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 2 Levetiracetam Monotherapy | Women with Epilepsy on Levetiracetam Monotherapy |
| OG002 | 1 Lamotrigine Monotherapy | Women with Epilepsy on Lamotrigine Monotherapy |
|
|
| Primary | Proportion of Women With PMDD in WWE and the Control Group | 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. | Posted | Count of Participants | Participants | Assessment of PMDD Designation after two consecutive menstrual cycles |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Levetiracetam | Women with Epilepsy on Levetiracetam Monotherapy | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Carbamazepine | Women with Epilepsy on Carbamazepine Monotherapy | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Control | Normal control (no epilepsy) | 0 | 20 | 0 | 20 | 0 | 20 |
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| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| No PMDD Designation |
|