{"protocolSection":{"identificationModule":{"nctId":"NCT01808612","orgStudyIdInfo":{"id":"14595"},"secondaryIdInfos":[{"id":"B1Y-JE-HCLV","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study of Fluoxetine in Major Depressive Disorder (MDD) Short-Term Dosing","officialTitle":"A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Parallel-Design Study to Evaluate the Short-Term, Fixed Dose Efficacy and Safety of LY110140 Once Daily Dosing in Japanese Patients With Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2015-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-03"},"primaryCompletionDateStruct":{"date":"2014-07","type":"ACTUAL"},"completionDateStruct":{"date":"2014-07","type":"ACTUAL"},"studyFirstSubmitDate":"2013-03-07","studyFirstSubmitQcDate":"2013-03-08","studyFirstPostDateStruct":{"date":"2013-03-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2015-04-24","resultsFirstSubmitQcDate":"2015-04-24","resultsFirstPostDateStruct":{"date":"2015-05-12","type":"ESTIMATED"},"lastUpdateSubmitDate":"2015-04-24","lastUpdatePostDateStruct":{"date":"2015-05-12","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to evaluate the short-term efficacy and safety of Fluoxetine in Japanese adult participants with Major Depressive Disorder (MDD)."},"conditionsModule":{"conditions":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":513,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"20 mg Fluoxetine","type":"EXPERIMENTAL","description":"20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks","interventionNames":["Drug: Fluoxetine"]},{"label":"40 mg Fluoxetine","type":"EXPERIMENTAL","description":"40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks","interventionNames":["Drug: Fluoxetine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo (capsules) administered orally, once daily, for 6 weeks","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Fluoxetine","armGroupLabels":["20 mg Fluoxetine","40 mg Fluoxetine"],"otherNames":["LY110140","Fluoxetine Hydrochloride","Prozac","Sarafem"]},{"type":"DRUG","name":"Placebo","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score","description":"HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.","timeFrame":"Baseline, 6 weeks"}],"secondaryOutcomes":[{"measure":"Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores","description":"HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.","timeFrame":"Baseline, 6 weeks"},{"measure":"Percentage of Participants Achieving a Response at 6-Week Endpoint","description":"The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.","timeFrame":"up to 6 weeks"},{"measure":"Percentage of Participants Achieving a Remission at 6-Week Endpoint","description":"The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.","timeFrame":"up to 6 weeks"},{"measure":"Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale","description":"CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.","timeFrame":"Baseline, 6 weeks"},{"measure":"Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores","description":"SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.","timeFrame":"Baseline, up to 6 weeks"},{"measure":"Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)","description":"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a \"yes\" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation is defined as a \"yes\" answer to any one of 5 suicidal ideation questions: wish to be dead, and 4 different categories of active suicidal ideation.","timeFrame":"Baseline through 6 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Outpatient Japanese participants diagnosed with MDD\n* Diagnosis of moderate or greater severity of MDD\n* Agree to abstain from sexual activity or to use a reliable method of birth control\n* Judged to be reliable (agree to keep appointments for clinic visits and to undergo all tests and examinations required by the protocol)\n\nExclusion Criteria:\n\n* Have previously been exposed to fluoxetine (LY110140) for any indication in the past\n* Significant suicidal risk\n* Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or post-traumatic stress disorder\n* Have a history of substance abuse or dependence within the past 6 months, excluding caffeine and nicotine\n* Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks\n* Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year\n* Have had treatment with a Monoamine oxidase inhibitor (MAOI) within 14 days\n* Need to use thioridazine or pimozide during the study\n* Have previously enrolled, completed, or withdrawn from this study\n* Have a positive urine drug screen for drugs with abuse potential\n* Female participants who are either pregnant, nursing, or have recently given birth, or male participants who are planning for their partners to be or become pregnant\n* Have a history of seizure disorder\n* Have frequent or severe allergic reactions to multiple medications\n* Have a serious or unstable medical illness or condition, or psychological condition\n* Participants deemed ineligible by the investigator or sub-investigator for other reasons","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Aichi","zip":"471-8513","country":"Japan","geoPoint":{"lat":32.51879,"lon":130.62158}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Chiba","zip":"270-0014","country":"Japan","geoPoint":{"lat":35.6,"lon":140.11667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Fukuoka","zip":"800-0226","country":"Japan","geoPoint":{"lat":33.6,"lon":130.41667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Fukushima","zip":"961-0021","country":"Japan","geoPoint":{"lat":37.75,"lon":140.46667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hiroshima","zip":"737-0143","country":"Japan","geoPoint":{"lat":34.4,"lon":132.45}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hokkaido","zip":"065-0012","country":"Japan"},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hyōgo","zip":"651-0097","country":"Japan","geoPoint":{"lat":43.36667,"lon":144.43333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kanagawa","zip":"238-0042","country":"Japan","geoPoint":{"lat":37.58333,"lon":139.91667}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Kyoto","zip":"616-8421","country":"Japan","geoPoint":{"lat":35.02107,"lon":135.75385}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Nagano","zip":"390-0303","country":"Japan","geoPoint":{"lat":36.65,"lon":138.18333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Okayama","zip":"700-0907","country":"Japan","geoPoint":{"lat":34.65,"lon":133.93333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Osaka","zip":"586-0012","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Saitama","zip":"339-0057","country":"Japan","geoPoint":{"lat":35.90807,"lon":139.65657}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Shiga","zip":"525-0037","country":"Japan","geoPoint":{"lat":36.02247,"lon":138.13005}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tochigi","zip":"321-0953","country":"Japan","geoPoint":{"lat":36.38333,"lon":139.73333}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Tokyo","zip":"170-0002","country":"Japan","geoPoint":{"lat":35.6895,"lon":139.69171}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"This study consisted of 3 periods: a single-blind screening period (1 week of placebo), a double-blind short-term treatment period (1 week of placebo followed by randomization in a 2:1:3 fashion to 20 milligrams \\[mg\\] fluoxetine, 40 mg fluoxetine, or placebo, respectively, for 6 weeks), and a single-blind discontinuation period (2 weeks of placebo).","groups":[{"id":"FG000","title":"20 mg Fluoxetine","description":"Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks\n\nDiscontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"},{"id":"FG001","title":"40 mg Fluoxetine","description":"Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks\n\nDiscontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"},{"id":"FG002","title":"Placebo","description":"Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks\n\nDiscontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"}],"periods":[{"title":"Treatment Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"169"},{"groupId":"FG001","numSubjects":"84"},{"groupId":"FG002","numSubjects":"260"}]},{"type":"Received at Least 1 Dose of Study Drug","achievements":[{"groupId":"FG000","comment":"Only these participants were included in the study analyses (ie, Full Analysis Set).","numSubjects":"168"},{"groupId":"FG001","comment":"Only these participants were included in the study analyses (ie, Full Analysis Set).","numSubjects":"83"},{"groupId":"FG002","comment":"Only these participants were included in the study analyses (ie, Full Analysis Set).","numSubjects":"259"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"67 participants who completed the Treatment Period did not enter the Discontinuation Period.","numSubjects":"154"},{"groupId":"FG001","comment":"39 participants who completed the Treatment Period did not enter the Discontinuation Period.","numSubjects":"77"},{"groupId":"FG002","comment":"101 participants who completed the Treatment Period did not enter the Discontinuation Period.","numSubjects":"246"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"14"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"3"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"2"}]}]},{"title":"Discontinuation Period","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"87"},{"groupId":"FG001","numSubjects":"38"},{"groupId":"FG002","numSubjects":"145"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"85"},{"groupId":"FG001","numSubjects":"37"},{"groupId":"FG002","numSubjects":"145"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"All randomized participants who received at least 1 dose of study drug.","groups":[{"id":"BG000","title":"20 mg Fluoxetine","description":"20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"BG001","title":"40 mg Fluoxetine","description":"40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"BG002","title":"Placebo","description":"Placebo (capsules) administered orally, once daily, for 6 weeks"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"168"},{"groupId":"BG001","value":"83"},{"groupId":"BG002","value":"259"},{"groupId":"BG003","value":"510"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40.05","spread":"11.19"},{"groupId":"BG001","value":"39.58","spread":"10.56"},{"groupId":"BG002","value":"38.54","spread":"11.65"},{"groupId":"BG003","value":"39.20","spread":"11.33"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"83"},{"groupId":"BG001","value":"33"},{"groupId":"BG002","value":"129"},{"groupId":"BG003","value":"245"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"85"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"130"},{"groupId":"BG003","value":"265"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"168"},{"groupId":"BG001","value":"83"},{"groupId":"BG002","value":"259"},{"groupId":"BG003","value":"510"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"168"},{"groupId":"BG001","value":"83"},{"groupId":"BG002","value":"259"},{"groupId":"BG003","value":"510"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"168"},{"groupId":"BG001","value":"83"},{"groupId":"BG002","value":"259"},{"groupId":"BG003","value":"510"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Mean Change From Baseline to 6-Week Endpoint on the 21-Item Hamilton Depression Rating Scale (HAMD21) Total Score","description":"HAMD21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 64 (severely depressed). Least squares (LS) means were calculated using mixed-model repeated measures (MMRM) adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline HAMD21 total score.","populationDescription":"Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"20 mg Fluoxetine","description":"20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG001","title":"40 mg Fluoxetine","description":"40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo (capsules) administered orally, once daily, for 6 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"259"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.18","spread":"0.57"},{"groupId":"OG001","value":"-6.25","spread":"0.77"},{"groupId":"OG002","value":"-6.91","spread":"0.49"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Approximately 522 participants were to be enrolled. Randomization was to be 2:1:3 (20 mg fluoxetine:40 mg fluoxetine:placebo). Assuming 5% of participants would have missing post-baseline data, the study had 85% power to detect an effect size of 0.33 (20 mg fluoxetine compared to placebo on HAMD21 total score) based on simulations with a 0.05 two-sided significance level.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.264","statisticalMethod":"Mixed Models Analysis","paramType":"LS Mean Difference","paramValue":"0.73","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.55","ciUpperLimit":"2.00"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 6-Week Endpoint on the HAMD21 Subscale Scores","description":"HAMD17 total scores and subscale scores from the HAMD21 are presented. HAMD17 is a 17-item assessment of depression severity (total scores range from 0-52). The Maier subscale (Items 1, 2, 7-10) represents the core symptoms of depression (0-24). Anxiety/Somatization subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation (0-18). Retardation/Somatization subscale (Items 1, 7, 8, 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation (0-14). Sleep subscale (Items 4-6) assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher scores indicate more severe symptoms. LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline score.","populationDescription":"Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 subscale score during the Treatment Period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"20 mg Fluoxetine","description":"20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG001","title":"40 mg Fluoxetine","description":"40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo (capsules) administered orally, once daily, for 6 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"259"}]}],"classes":[{"title":"HAMD17 total score","categories":[{"measurements":[{"groupId":"OG000","value":"-5.59","spread":"0.53"},{"groupId":"OG001","value":"-5.61","spread":"0.71"},{"groupId":"OG002","value":"-6.27","spread":"0.45"}]}]},{"title":"Maier subscale score","categories":[{"measurements":[{"groupId":"OG000","value":"-3.35","spread":"0.30"},{"groupId":"OG001","value":"-3.39","spread":"0.40"},{"groupId":"OG002","value":"-3.30","spread":"0.26"}]}]},{"title":"Anxiety/Somatization subscale score","categories":[{"measurements":[{"groupId":"OG000","value":"-2.04","spread":"0.21"},{"groupId":"OG001","value":"-1.84","spread":"0.28"},{"groupId":"OG002","value":"-2.06","spread":"0.18"}]}]},{"title":"Retardation/Somatization subscale score","categories":[{"measurements":[{"groupId":"OG000","value":"-2.00","spread":"0.20"},{"groupId":"OG001","value":"-2.21","spread":"0.27"},{"groupId":"OG002","value":"-2.23","spread":"0.17"}]}]},{"title":"Sleep subscale score","categories":[{"measurements":[{"groupId":"OG000","value":"-0.83","spread":"0.15"},{"groupId":"OG001","value":"-0.81","spread":"0.20"},{"groupId":"OG002","value":"-1.10","spread":"0.13"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving a Response at 6-Week Endpoint","description":"The percentage of participants achieving a response (defined as a ≥50% improvement from baseline on the HAMD21 total score) was calculated by dividing the number of participants achieving a response at last observation by the total number of participants at risk, multiplied by 100.","populationDescription":"Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"up to 6 weeks","groups":[{"id":"OG000","title":"20 mg Fluoxetine","description":"20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG001","title":"40 mg Fluoxetine","description":"40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo (capsules) administered orally, once daily, for 6 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"259"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.8"},{"groupId":"OG001","value":"18.1"},{"groupId":"OG002","value":"27.8"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving a Remission at 6-Week Endpoint","description":"The percentage of participants achieving a remission (defined as a HAMD21 total score ≤7) was calculated by dividing the number of participants achieving a remission at last observation by the total number of participants at risk, multiplied by 100.","populationDescription":"Randomized participants who received at least 1 dose of study drug with a baseline (which had not achieved remission threshold criteria) and had at least 1 post-baseline HAMD21 total score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only post-baseline data.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"up to 6 weeks","groups":[{"id":"OG000","title":"20 mg Fluoxetine","description":"20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG001","title":"40 mg Fluoxetine","description":"40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo (capsules) administered orally, once daily, for 6 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"258"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.5"},{"groupId":"OG001","value":"9.6"},{"groupId":"OG002","value":"15.1"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 6-Week Endpoint on the Clinical Global Impression of Severity (CGI-S) Scale","description":"CGI-S measures severity of illness at the time of assessment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). LS means were calculated using MMRM adjusting for the random effect of participant and fixed categorical effects of treatment, pooled investigative site, visit, and treatment-by-visit interaction, as well as the continuous fixed covariate of baseline CGI-S score.","populationDescription":"Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline CGI-S score during the Treatment Period.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, 6 weeks","groups":[{"id":"OG000","title":"20 mg Fluoxetine","description":"20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG001","title":"40 mg Fluoxetine","description":"40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo (capsules) administered orally, once daily, for 6 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"168"},{"groupId":"OG001","value":"83"},{"groupId":"OG002","value":"259"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.69","spread":"0.08"},{"groupId":"OG001","value":"-0.67","spread":"0.11"},{"groupId":"OG002","value":"-0.81","spread":"0.07"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 6-Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores","description":"SDS was completed by the participant and was used to assess the effect of the participant's symptoms on their work/school (Item 1), social life/leisure activities (Item 2), and family life/home responsibilities (Item 3). Each item was measured on a 0 (not at all) to 10 (extremely) point scale with higher values indicating greater disruption. Total score was the sum of the 3 items and ranged from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. LS means were calculated using analysis of covariance (ANCOVA) adjusting for treatment, pooled investigative site, and baseline SDS score.","populationDescription":"Randomized participants who received at least 1 dose of study drug with a baseline and at least 1 post-baseline SDS score during the Treatment Period. Missing endpoints were imputed with the last observation carried forward (LOCF) method, using only postbaseline data.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Baseline, up to 6 weeks","groups":[{"id":"OG000","title":"20 mg Fluoxetine","description":"20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG001","title":"40 mg Fluoxetine","description":"40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks"},{"id":"OG002","title":"Placebo","description":"Placebo (capsules) administered orally, once daily, for 6 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"167"},{"groupId":"OG001","value":"81"},{"groupId":"OG002","value":"259"}]}],"classes":[{"title":"Total score (n=167, 81, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"-1.76","spread":"0.59"},{"groupId":"OG001","value":"-1.55","spread":"0.78"},{"groupId":"OG002","value":"-1.99","spread":"0.53"}]}]},{"title":"Work/School subscale score (n=143, 64, 226)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.79","spread":"0.27"},{"groupId":"OG001","value":"-0.34","spread":"0.36"},{"groupId":"OG002","value":"-0.88","spread":"0.24"}]}]},{"title":"Social/Leisure subscale score (n=167, 81, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.66","spread":"0.23"},{"groupId":"OG001","value":"-0.81","spread":"0.30"},{"groupId":"OG002","value":"-0.70","spread":"0.21"}]}]},{"title":"Family/Home subscale score (n=167, 81, 259)","categories":[{"measurements":[{"groupId":"OG000","value":"-0.47","spread":"0.21"},{"groupId":"OG001","value":"-0.30","spread":"0.28"},{"groupId":"OG002","value":"-0.41","spread":"0.19"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)","description":"C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Suicidal behavior is defined as a \"yes\" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. 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