{"protocolSection":{"identificationModule":{"nctId":"NCT00965562","nctIdAliases":["NCT00683605"],"orgStudyIdInfo":{"id":"0001011511"},"organization":{"fullName":"Donaghue Medical Research Foundation","class":"OTHER"},"briefTitle":"Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)","officialTitle":"A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)"},"statusModule":{"statusVerifiedDate":"2015-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2000-09"},"primaryCompletionDateStruct":{"date":"2010-06","type":"ACTUAL"},"completionDateStruct":{"date":"2010-10","type":"ACTUAL"},"studyFirstSubmitDate":"2009-08-24","studyFirstSubmitQcDate":"2009-08-24","studyFirstPostDateStruct":{"date":"2009-08-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-07-02","resultsFirstSubmitQcDate":"2015-02-10","resultsFirstPostDateStruct":{"date":"2015-02-26","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-03-03","lastUpdatePostDateStruct":{"date":"2015-03-23","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Kimberly Yonkers","investigatorTitle":"Professor","investigatorAffiliation":"Yale University"},"leadSponsor":{"name":"Donaghue Medical Research Foundation","class":"OTHER"},"collaborators":[{"name":"Yale University","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit.","detailedDescription":"This is a double blind, randomized, placebo controlled, parallel study that will randomize 60 women at the Yale site into treatment. Participants will be screened at various collaborating ob-gyn centers for possible PMS symptoms, and direct referrals from the community will also be accepted. Subject participation length is about 7 months with 6 scheduled study visits.\n\nMethodology: After successfully completing the screening and qualification phase, participants will be randomized to treatment at Visit 1 for 5 cycles of double-blind treatment. Participants will be evaluated monthly during the randomization phase for adverse events, concurrent medication, and primary and secondary efficacy variables.\n\n."},"conditionsModule":{"conditions":["Premenstrual Syndrome"],"keywords":["Premenstrual syndrome","PMS","calcium"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":49,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"I","type":"ACTIVE_COMPARATOR","description":"Fluoxetine","interventionNames":["Drug: Fluoxetine"]},{"label":"II","type":"ACTIVE_COMPARATOR","description":"Calcium","interventionNames":["Drug: Calcium"]},{"label":"III","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Fluoxetine","description":"Fluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200mg of calcium.","armGroupLabels":["I"],"otherNames":["Prozac"]},{"type":"DRUG","name":"Calcium","description":"1200 mg of calcium to be taken for 5 menstrual cycles.","armGroupLabels":["II"]},{"type":"DRUG","name":"Placebo","description":"For 5 cycles, women will receive placebo. At the end of the fourth cycle, all women will receive 1200 mg of calcium in addition to the placebo medication.","armGroupLabels":["III"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Comparison of the Change in IDS Symptom Scores Among Groups","description":"IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Comparison of the Change in PMTS Symptom Scores Among Groups","description":"PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Comparison of the Change in CGI-S Symptom Scores Among Groups","description":"CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Comparison of the Change in DRSP Symptom Scores Among Groups","description":"DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Comparison of the Change in CGI Improvement Scores Among Groups","description":"CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit"}],"secondaryOutcomes":[{"measure":"Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)","description":"DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)","description":"IDS: Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=least severe, 84=most severe). LOCF: last observation carried forward.","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)","description":"PMTS: Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). LOCF: last observation carried forward.","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)","description":"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.","timeFrame":"over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)","description":"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit.\n\nIDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency, sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe).","timeFrame":"over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit"},{"measure":"Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)","description":"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe).","timeFrame":"over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Female outpatients between the ages of 18 and 48 who are:\n\n  * Menstruating\n  * Meet criteria for moderate to severe PMS\n  * Report PMS symptoms for at least 9 our of the 12 months prior to screening; 4) \\*Are using an adequate method of birth control.\n\nExclusion Criteria:\n\n* Any candidate who:\n\n  * Fulfills MINI (DSM-IV) criteria for a serious AXIS 1 disorder\n  * Fulfills DSM-IV criteria during the charting phase consistent with a diagnosis of psychotic disorder, bipolar disorder or major depressive disorder\n  * Has a severe, co-existing condition that, in the investigator's opinion, renders the patient unsuitable for the study\n  * Poses a significant risk of suicide\n  * Takes ongoing medication that could treat PMS symptoms\n  * Has a history of hypersensitivity or adverse reaction to fluoxetine or calcium\n  * Is lactating, pregnant or is planning to become pregnant during the course of the study.","healthyVolunteers":false,"sex":"FEMALE","minimumAge":"18 Years","maximumAge":"48 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Kimberly A Yonkers, MD","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Yale School of Medicine","city":"New Haven","state":"Connecticut","zip":"06510","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Recruitment occurred through on-site screening in private gynecological practices and community advertisements. Recruitment occurred between 2001-2005 in Providence, Rhode Island and between 2001-2009 in New Haven, Connecticut. Potential subjects provided consent for screening and assessment.","groups":[{"id":"FG000","title":"I: Fluoxetine","description":"Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles."},{"id":"FG001","title":"II: Calcium","description":"Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles."},{"id":"FG002","title":"III: Placebo","description":"Placebo : For 4 cycles, women will receive placebo."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"17"},{"groupId":"FG002","numSubjects":"16"}]},{"type":"Women With at Least 2 Follow up Visits","achievements":[{"groupId":"FG000","comment":"3 patients with no follow up visits: 1 out of contact, 2 patient requests","numSubjects":"13"},{"groupId":"FG001","comment":"4 patients with no follow up visits: 2 out of contact, 2 patient requests","numSubjects":"13"},{"groupId":"FG002","comment":"3 patients with no follow up visits: 3 out of contact","numSubjects":"13"}]},{"type":"Women Who Participated Full Follow up","achievements":[{"groupId":"FG000","comment":"7 patients discontinued intervention: 2 out of contact, 4 patient requests, 1 suspended by IRB","numSubjects":"6"},{"groupId":"FG001","comment":"3 patients discontinued intervention: 1 out of contact, 2 patient requests","numSubjects":"10"},{"groupId":"FG002","comment":"2 patients discontinued intervention: 2 patient requests","numSubjects":"11"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Participants who completed at least 2 visits were analyzed.","numSubjects":"13"},{"groupId":"FG001","comment":"Participants who completed at least 2 visits were analyzed.","numSubjects":"13"},{"groupId":"FG002","comment":"Participants who completed at least 2 visits were analyzed.","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Participants with at least 2 follow up visits were included in analysis.","groups":[{"id":"BG000","title":"I: Fluoxetine","description":"Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles."},{"id":"BG001","title":"II: Calcium","description":"Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles."},{"id":"BG002","title":"III: Placebo","description":"Placebo : For 4 cycles, women will receive placebo."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"39"}]}],"measures":[{"title":"Age, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"25-29 years old","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}]},{"title":"30-39 years old","categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"7"},{"groupId":"BG003","value":"24"}]}]},{"title":"40-45 years old","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"11"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"39"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"28"}]}]},{"title":"Black","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]},{"title":"Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"2"}]}]},{"title":"Other/Mixed","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"}]}]},{"title":"Not collected","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"4"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"39"}]}]}]},{"title":"Marital Status","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Married","categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"24"}]}]},{"title":"Single/Divorced/Widowed","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"4"},{"groupId":"BG003","value":"14"}]}]},{"title":"Not collected","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Number of pregnancies","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"0 pregnancies","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"5"},{"groupId":"BG003","value":"14"}]}]},{"title":"1 pregnancy","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"4"}]}]},{"title":"2+ pregnancies","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"8"},{"groupId":"BG003","value":"21"}]}]}]},{"title":"Years with PMS","description":"PMS= premenstrual syndrome.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"<4 years","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"14"}]}]},{"title":"5-10 years","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"1"},{"groupId":"BG003","value":"10"}]}]},{"title":">10 years","categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"14"}]}]},{"title":"Number of years not collected","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"1"}]}]}]},{"title":"Ever spoken to a doctor about PMS","description":"PMS= premenstrual syndrome. Only participants who indicated that they had spoken to a doctor about their PMS were included in this affirmative measure.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"15"}]}]}]},{"title":"OB-GYN asked about PMS","description":"PMS= premenstrual syndrome. Only participants who indicated that their OB-GYN had asked about PMS were included in this affirmative measure.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"9"}]}]}]},{"title":"Thought about getting help for PMS","description":"PMS= premenstrual syndrome. Only participants who indicated that they had thought about getting help for their PMS symptoms were included in this affirmative measure.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"7"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"20"}]}]}]},{"title":"Concurrent oral contraceptive use","description":"Only participants who indicated that they were concurrently taking contraceptives were included in this affirmative measure.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"10"}]}]}]},{"title":"Baseline Symptom Scores","description":"IDS= sum of responses to 28 of 30 possible items each scored 0 to 3 points (0=least severe 84= most severe); PMTS= total score 10 items, each with 4 points (0 is no symptom and 40 total = most severe); CGI-S= illness severity (1=normal 7=among most critically ill) . The IDS, PMTS, and CGI-S were scored on the basis of severity during the prior premenstrual phase. DRSP= 21 items each with scale (1=no symptom 6=extreme); The DRSP score was generated by subtracting average follicular phase severity from average luteal phase severity, and averaging these phase change means across symptoms.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"title":"Inventory of Depressive Symptomatology (IDS-C30)","categories":[{"measurements":[{"groupId":"BG000","value":"31.85","spread":"9.14"},{"groupId":"BG001","value":"30.92","spread":"7.62"},{"groupId":"BG002","value":"28.85","spread":"9.97"},{"groupId":"BG003","value":"30.54","spread":"5.17"}]}]},{"title":"Premenstrual Tension Syndrome-Observer (PMTS-O)","categories":[{"measurements":[{"groupId":"BG000","value":"24.15","spread":"5.40"},{"groupId":"BG001","value":"21.58","spread":"3.73"},{"groupId":"BG002","value":"20.85","spread":"6.62"},{"groupId":"BG003","value":"22.19","spread":"3.11"}]}]},{"title":"Daily Record of Severity of Problems (DRSP)","categories":[{"measurements":[{"groupId":"BG000","value":"2.16","spread":"0.86"},{"groupId":"BG001","value":"1.12","spread":"0.38"},{"groupId":"BG002","value":"1.29","spread":"0.60"},{"groupId":"BG003","value":"1.52","spread":"0.37"}]}]},{"title":"Clinical Global Impression - Severity (CGI-S)","categories":[{"measurements":[{"groupId":"BG000","value":"4.92","spread":"0.95"},{"groupId":"BG001","value":"4.46","spread":"1.27"},{"groupId":"BG002","value":"4.15","spread":"1.28"},{"groupId":"BG003","value":"4.51","spread":"0.68"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"SECONDARY","title":"Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)","description":"DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.","populationDescription":"Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"proportion of participants","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit","groups":[{"id":"OG000","title":"I: Fluoxetine","description":"Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles."},{"id":"OG001","title":"II: Calcium","description":"Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles."},{"id":"OG002","title":"III: Placebo","description":"Placebo : For 4 cycles, women will receive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.80"},{"groupId":"OG001","value":"0.42"},{"groupId":"OG002","value":"0.42"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.15","statisticalMethod":"Chi-squared","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)","description":"IDS: Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=least severe, 84=most severe). LOCF: last observation carried forward.","populationDescription":"Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"proportion of participants","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit","groups":[{"id":"OG000","title":"I: Fluoxetine","description":"Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles."},{"id":"OG001","title":"II: Calcium","description":"Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles."},{"id":"OG002","title":"III: Placebo","description":"Placebo : For 5 cycles, women will receive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.77"},{"groupId":"OG001","value":"0.31"},{"groupId":"OG002","value":"0.31"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.05","statisticalMethod":"Chi-squared","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)","description":"PMTS: Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). LOCF: last observation carried forward.","populationDescription":"Response analysis includes all data from all subjects with the last observation carried forward to Visit 5.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"proportion of participants","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit","groups":[{"id":"OG000","title":"I: Fluoxetine","description":"Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles."},{"id":"OG001","title":"II: Calcium","description":"Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles."},{"id":"OG002","title":"III: Placebo","description":"Placebo : For 4 cycles, women will receive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"13"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.62"},{"groupId":"OG001","value":"0.33"},{"groupId":"OG002","value":"0.16"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.06","statisticalMethod":"Chi-squared","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)","description":"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.","populationDescription":"For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5. However, Visit 5 DRSP calendars were missing for an additional 3 subjects in the fluoxetine group and for one subject in each of the calcium and placebo cells.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"proportion of participants","timeFrame":"over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit","groups":[{"id":"OG000","title":"I: Fluoxetine","description":"Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles."},{"id":"OG001","title":"II: Calcium","description":"Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles."},{"id":"OG002","title":"III: Placebo","description":"Placebo : For 5 cycles, women will receive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"6"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00"},{"groupId":"OG001","value":"0.50"},{"groupId":"OG002","value":"0.33"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.09","statisticalMethod":"Chi-squared","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)","description":"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit.\n\nIDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency, sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe).","populationDescription":"For fluoxetine, calcium and placebo groups, 8, 11 and 12 participants remained in the trial until Visit 5.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"proportion of participants","timeFrame":"over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit","groups":[{"id":"OG000","title":"I: Fluoxetine","description":"Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles."},{"id":"OG001","title":"II: Calcium","description":"Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles."},{"id":"OG002","title":"III: Placebo","description":"Placebo : For 4 cycles, women will receive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"12"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.00"},{"groupId":"OG001","value":"0.36"},{"groupId":"OG002","value":"0.33"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","statisticalMethod":"Chi-squared","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)","description":"Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. 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This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.","populationDescription":"Intention to treat cohort.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on DRSP scale","timeFrame":"over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit","groups":[{"id":"OG000","title":"I: Fluoxetine","description":"Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles."},{"id":"OG001","title":"II: Calcium","description":"Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles."},{"id":"OG002","title":"III: Placebo","description":"Placebo : For 4 cycles, women will receive placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"13"}]}],"classes":[{"title":"Visit 1","categories":[{"measurements":[{"groupId":"OG000","value":"2.16","spread":"0.86"},{"groupId":"OG001","value":"1.12","spread":"0.38"},{"groupId":"OG002","value":"1.29","spread":"0.60"}]}]},{"title":"Visit 2","categories":[{"measurements":[{"groupId":"OG000","value":"0.97","spread":"0.72"},{"groupId":"OG001","value":"0.76","spread":"0.78"},{"groupId":"OG002","value":"0.93","spread":"0.54"}]}]},{"title":"Visit 3","categories":[{"measurements":[{"groupId":"OG000","value":"0.27","spread":"0.78"},{"groupId":"OG001","value":"0.61","spread":"0.78"},{"groupId":"OG002","value":"1.19","spread":"1.06"}]}]},{"title":"Visit 4","categories":[{"measurements":[{"groupId":"OG000","value":"0.72","spread":"0.78"},{"groupId":"OG001","value":"0.51","spread":"0.33"},{"groupId":"OG002","value":"0.59","spread":"0.63"}]}]},{"title":"Visit 5","categories":[{"measurements":[{"groupId":"OG000","value":"0.44","spread":"0.34"},{"groupId":"OG001","value":"0.75","spread":"0.42"},{"groupId":"OG002","value":"0.74","spread":"0.54"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.02","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":"-0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.53","ciUpperLimit":"-0.04","estimateComment":"Slope represents average change in fluoxetine group DRSP scores as compared to placebo"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.58","statisticalMethod":"Mixed Models Analysis","paramType":"Slope","paramValue":"0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.16","ciUpperLimit":"0.28","estimateComment":"Slope represents average change in calcium group DRSP scores as compared to placebo"},{"groupIds":["OG000","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.02","statisticalMethod":"Mixed Models Analysis","paramType":"Cohen's d effect size","paramValue":"2.08","ciNumSides":"TWO_SIDED","estimateComment":"Cohen's d effect sizes were calculated by subtracting the difference between changes in the fluoxetine group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5"},{"groupIds":["OG001","OG002"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.58","statisticalMethod":"Mixed Models Analysis","paramType":"Cohen's d effect size","paramValue":"0.18","ciNumSides":"TWO_SIDED","estimateComment":"Cohen's d effect sizes were calculated by subtracting the difference between changes in the calcium group between visits 1 and 5 and changes in the placebo group between Visits 1 and 5, divided by the std dev in the placebo group at Visit 5"}]},{"type":"PRIMARY","title":"Comparison of the Change in CGI Improvement Scores Among Groups","description":"CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). 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