{"protocolSection":{"identificationModule":{"nctId":"NCT00676026","orgStudyIdInfo":{"id":"0505027759"},"organization":{"fullName":"University of Pennsylvania","class":"OTHER"},"briefTitle":"Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women","officialTitle":"The Impact of GABA-Enhancing Agents on Cortical GABA Concentrations Across the Menstrual Cycle in Women"},"statusModule":{"statusVerifiedDate":"2017-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-05"},"primaryCompletionDateStruct":{"date":"2009-02","type":"ACTUAL"},"completionDateStruct":{"date":"2009-02","type":"ACTUAL"},"studyFirstSubmitDate":"2008-04-07","studyFirstSubmitQcDate":"2008-05-09","studyFirstPostDateStruct":{"date":"2008-05-12","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-03-20","resultsFirstSubmitQcDate":"2017-05-25","resultsFirstPostDateStruct":{"date":"2017-06-01","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-05-25","lastUpdatePostDateStruct":{"date":"2017-06-01","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Pennsylvania","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The goal of this series of challenge studies is to examine the impact of menstrual cycle phase on cortical GABA response to administration of agents with either direct (benzodiazepines) or indirect (progesterone, fluoxetine) GABA modulating properties. While the impact of these agents on cortical GABA levels in women with premenstrual dysphoric disorder (PMDD) is of interest, this study is designed primarily for those women without a psychiatric illness."},"conditionsModule":{"conditions":["Healthy"],"keywords":["menses","women","healthy controls","Healthy females with regular menstrual cycles"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","primaryPurpose":"OTHER","maskingInfo":{"masking":"SINGLE","whoMasked":["PARTICIPANT"]}},"enrollmentInfo":{"count":8,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Zolpidem 1","type":"EXPERIMENTAL","description":"Zolpidem will be administered twice to each participant; once in the follicular and luteal phases of the menstrual cycle.","interventionNames":["Drug: Zolpidem"]},{"label":"Progesterone 2","type":"EXPERIMENTAL","description":"Progesterone will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.","interventionNames":["Drug: Progesterone"]},{"label":"Fluoxetine 3","type":"EXPERIMENTAL","description":"Fluoxetine will be administered twice to each participant; once in both the follicular and luteal phases of the menstrual cycle.","interventionNames":["Drug: Fluoxetine"]}],"interventions":[{"type":"DRUG","name":"Fluoxetine","description":"Fluoxetine 20 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.","armGroupLabels":["Fluoxetine 3"],"otherNames":["Prozac"]},{"type":"DRUG","name":"Zolpidem","description":"Zolpidem 10 mg by mouth in the follicular and luteal phase of the menstrual cycle per participant.","armGroupLabels":["Zolpidem 1"],"otherNames":["Ambien"]},{"type":"DRUG","name":"Progesterone","description":"Progesterone 800 mg by mouth will be administered to each participant once in the follicular and luteal phases of the menstrual cycle.","armGroupLabels":["Progesterone 2"],"otherNames":["Prometrium"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.","description":"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.","timeFrame":"Each medication will be administered 2 times during a 1-month menstrual cycle."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Women ages 18-45 and able to give voluntary written informed consent;\n* Regular menstrual periods of 24-35 days in length;\n* Body mass index 18.5 to 30 kg/m2;\n* No past or present DSM-IV psychiatric or substance dependence diagnosis by structured diagnostic interview (SCID-NP); no substance abuse history within the previous 2 years;\n* Absence of mood symptoms across the menstrual cycle during one month of prospective daily ratings with the Daily Record of Severity of Problems (DRSP); the DRSP is based on the DSM-IV research criteria for premenstrual dysphoric disorder (PMDD) and has been used in numerous studies to confirm the presence or absence of significant premenstrual mood and behavioral difficulties;\n* Must be willing and able to participate in at least three of the four challenge paradigms.\n\nExclusion Criteria:\n\n* Medical, neurologic or cerebrovascular disorder (CVA, seizure disorder, etc.);\n* Family history of first degree relative with an Axis I psychiatric or substance dependence disorder (excepting alcohol and nicotine) (per subject report);\n* Current treatment with psychoactive medication;\n* Diabetes controlled by means other than diet;\n* Use of steroid contraceptives (any method involving hormones) within the previous 4 months;\n* Habitual consumption of more than 7 alcoholic drinks per week or more than 2 drinks on any particular occasion; must be willing to abstain from alcohol consumption for 48 hours prior to each 1H-MRS scan;\n* Implanted metallic devices.","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"45 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Cynthia N Epperson, MD","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Yale University School of Medicine; Yale Program for Women's Reproductive Behavioral Health","city":"New Haven","state":"Connecticut","zip":"06511","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Participants were recruited at an outpatient research facility located at Yale University in New Haven, CT.","groups":[{"id":"FG000","title":"All Participants","description":"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"8"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"As far as we know, data was never analyzed for this study. We only know that 8 participants completed.","groups":[{"id":"BG000","title":"All Participants","description":"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"}]}],"measures":[{"title":"Age, Continuous","populationDescription":"UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.","unitOfMeasure":"years"},{"title":"Sex: Female, Male","populationDescription":"UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.","classes":[{"categories":[{"title":"Female"},{"title":"Male"}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"To Determine the Impact of GABA-A Receptor Agonists (Benzodiazepines, Allopregnanolone) and Other GABA-modulating Agents (Fluoxetine) on Cortical GABA Levels by Menstrual Cycle Phase as Measured Using 1H-MRS in Healthy Controls.","description":"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.","populationDescription":"UPenn does not have access to the data collected for this study. We are only using the information entered in the protocol section for very basic details in the results section (i.e, number of participants completed). The original contact person for this protocol is not reachable.","reportingStatus":"POSTED","timeFrame":"Each medication will be administered 2 times during a 1-month menstrual cycle.","groups":[{"id":"OG000","title":"All Participants","description":"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 18, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"Entire study duration.","eventGroups":[{"id":"EG000","title":"All Participants","description":"This study was conducted at Yale University almost two decades ago. Our group at the University of Pennsylvania only has very basic information about this study. This includes the number of participants, which was 8, and the fact that no adverse events occurred. Staff members at the University of Pennsylvania do not have access to any additional study data. The contact person who initially entered this study protocol information is no longer at the University of Pennsylvania and we are unable to contact for additional information.","deathsNumAffected":0,"deathsNumAtRisk":8,"seriousNumAffected":0,"seriousNumAtRisk":8,"otherNumAffected":0,"otherNumAtRisk":8}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Cynthia Neill Epperson, M.D.","organization":"University of Pennsylvania","email":"cepp@mail.med.upenn.edu","phone":"215-573-8871"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D005473","term":"Fluoxetine"},{"id":"D000077334","term":"Zolpidem"},{"id":"D011374","term":"Progesterone"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011725","term":"Pyridines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011282","term":"Pregnenediones"},{"id":"D011283","term":"Pregnenes"},{"id":"D011278","term":"Pregnanes"},{"id":"D013256","term":"Steroids"},{"id":"D000072473","term":"Fused-Ring Compounds"},{"id":"D011083","term":"Polycyclic Compounds"},{"id":"D003339","term":"Corpus Luteum Hormones"},{"id":"D042341","term":"Gonadal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"},{"id":"D045167","term":"Progesterone Congeners"},{"id":"D012739","term":"Gonadal Steroid Hormones"}]}},"hasResults":true}