Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-01-27 @ 8:40 AM
Study NCT ID:
NCT00612235
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2008-01-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Premenstrual Dysphoric Disorder and Antiepileptic Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077213', 'term': 'Lamotrigine'}, {'id': 'D000077287', 'term': 'Levetiracetam'}, {'id': 'D002220', 'term': 'Carbamazepine'}], 'ancestors': [{'id': 'D014227', 'term': 'Triazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aherzog@bidmc.harvard.edu', 'phone': '781-431-0277', 'title': 'Andrew G. Herzog M.D., M.Sc.', 'organization': 'Beth Israel Deaconess Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Lamotrigine', 'description': 'Women with Epilepsy on Lamotrigine Monotherapy', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Levetiracetam', 'description': 'Women with Epilepsy on Levetiracetam Monotherapy', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Carbamazepine', 'description': 'Women with Epilepsy on Carbamazepine Monotherapy', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control', 'description': 'Normal control (no epilepsy)', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '3 Carbamazepine Monotherapy', 'description': 'Women with Epilepsy on Carbamazepine Monotherapy'}, {'id': 'OG001', 'title': '2 Levetiracetam Monotherapy', 'description': 'Women with Epilepsy on Levetiracetam Monotherapy'}, {'id': 'OG002', 'title': '1 Lamotrigine Monotherapy', 'description': 'Women with Epilepsy on Lamotrigine Monotherapy'}], 'classes': [{'categories': [{'title': 'Endicott PMDD Designation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}, {'title': 'Less Stringent Threshold for PMDD Designation', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}, {'title': 'No PMDD Designation', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessment of PMDD Designation after two consecutive menstrual cycles', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Proportion of Women With PMDD in WWE and the Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Women With Epilepsy', 'description': 'Women with Epilepsy'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Women without Epilepsy'}], 'classes': [{'categories': [{'title': 'Endicott PMDD Designation', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Less Stringent Threshold for PMDD Designation', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'No PMDD Designation', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessment of PMDD Designation after two consecutive menstrual cycles', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 Lamotrigine Monotherapy', 'description': 'Women with Epilepsy on Lamotrigine Monotherapy'}, {'id': 'FG001', 'title': '2 Levetiracetam Monotherapy', 'description': 'Women with Epilepsy on Levetiracetam Monotherapy'}, {'id': 'FG002', 'title': '3 Carbamazepine Monotherapy', 'description': 'Women with Epilepsy on Carbamazepine Monotherapy'}, {'id': 'FG003', 'title': '5 Normal Control', 'description': 'Normal Control Women(no epilepsy)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '1 Lamotrigine Monotherapy', 'description': 'Women with Epilepsy on Lamotrigine Monotherapy'}, {'id': 'BG001', 'title': '2 Levetiracetam Monotherapy', 'description': 'Women with Epilepsy on Levetiracetam Monotherapy'}, {'id': 'BG002', 'title': '3 Carbamazepine Monotherapy', 'description': 'Women with Epilepsy on Carbamazepine Monotherapy'}, {'id': 'BG003', 'title': '5 Normal Control', 'description': 'Normal Control Women(no epilepsy)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.44', 'spread': '8.06', 'groupId': 'BG000'}, {'value': '33.08', 'spread': '7.57', 'groupId': 'BG001'}, {'value': '29.93', 'spread': '8.74', 'groupId': 'BG002'}, {'value': '31.79', 'spread': '8.21', 'groupId': 'BG003'}, {'value': '31.75', 'spread': '8.22', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Women with epilepsy on antiepileptic drug monotherapies and normal controls. There was no difference in the number who started and completed.'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-12', 'studyFirstSubmitDate': '2008-01-29', 'resultsFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2008-01-29', 'lastUpdatePostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-12', 'studyFirstPostDateStruct': {'date': '2008-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine if the Frequency of Premenstrual Dysphoric Disorder Differs Among Various Antiepileptic Drug Monotherapies.', 'timeFrame': 'Assessment of PMDD Designation after two consecutive menstrual cycles', 'description': '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'}, {'measure': 'Proportion of Women With PMDD in WWE and the Control Group', 'timeFrame': 'Assessment of PMDD Designation after two consecutive menstrual cycles', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['epilepsy', 'lamotrigine', 'levetiracetam', 'carbamazepine', 'phenytoin', 'lamictal', 'keppra', 'tegretol', 'carbatrol', 'dilantin'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '21724471', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Three regional epilepsy centers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Normal Control women, 18-45 years of age, in good general health by history\n\nExclusion Criteria:\n\n* Concomitant use of prescribed or OTC reproductive hormones\n* Concomitant use of antidepressant and anxiolytic medications such as SSRIs, bupropion, tricyclics, benzodiazepines'}, 'identificationModule': {'nctId': 'NCT00612235', 'briefTitle': 'Premenstrual Dysphoric Disorder and Antiepileptic Drugs', 'organization': {'class': 'OTHER', 'fullName': 'Beth Israel Deaconess Medical Center'}, 'officialTitle': 'Comparison of Different Antiepileptic Drug Monotherapies for the Occurrence of Premenstrual Dysphoric Disorder Among Women With Epilepsy', 'orgStudyIdInfo': {'id': '2007P000357'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lamotrigine Monotherapy', 'description': 'Lamotrigine Monotherapy', 'interventionNames': ['Drug: Lamotrigine']}, {'label': 'Levetiracetam Monotherapy', 'description': 'Levetiracetam Monotherapy', 'interventionNames': ['Drug: Levetiracetam']}, {'label': 'Carbamazepine Monotherapy', 'description': 'Carbamazepine Monotherapy', 'interventionNames': ['Drug: Carbamazepine']}, {'label': 'Normal control (no epilepsy)', 'description': 'Normal control (no epilepsy)', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'Lamotrigine', 'type': 'DRUG', 'otherNames': ['Lamictal'], 'description': 'Subjects had at least 3 months on a stable dosage of lamotrigine monotherapy.', 'armGroupLabels': ['Lamotrigine Monotherapy']}, {'name': 'Levetiracetam', 'type': 'DRUG', 'otherNames': ['Keppra'], 'description': 'Subjects had at least 3 months on a stable dosage of levetiracetam monotherapy.', 'armGroupLabels': ['Levetiracetam Monotherapy']}, {'name': 'Carbamazepine', 'type': 'DRUG', 'otherNames': ['Tegretol'], 'description': 'Subjects had at least 3 months on a stable dosage of carbamazepine monotherapy.', 'armGroupLabels': ['Carbamazepine Monotherapy']}, {'name': 'No Intervention', 'type': 'OTHER', 'description': 'No intervention was given', 'armGroupLabels': ['Normal control (no epilepsy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02462', 'city': 'Newton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Newton-Wellesley Hospital', 'geoPoint': {'lat': 42.33704, 'lon': -71.20922}}], 'overallOfficials': [{'name': 'Andrew G Herzog, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Newton-Wellesley Hospital', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Andrew Herzog', 'investigatorAffiliation': 'Beth Israel Deaconess Medical Center'}}}}