{"protocolSection":{"identificationModule":{"nctId":"NCT00696774","orgStudyIdInfo":{"id":"12349"},"secondaryIdInfos":[{"id":"F1J-CR-S022","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Switching to Duloxetine in Patients With Depression","officialTitle":"Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study)","acronym":"ARDENT"},"statusModule":{"statusVerifiedDate":"2010-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-06"},"primaryCompletionDateStruct":{"date":"2009-07","type":"ACTUAL"},"completionDateStruct":{"date":"2009-07","type":"ACTUAL"},"studyFirstSubmitDate":"2008-06-11","studyFirstSubmitQcDate":"2008-06-11","studyFirstPostDateStruct":{"date":"2008-06-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-07-15","resultsFirstSubmitQcDate":"2010-07-15","resultsFirstPostDateStruct":{"date":"2010-08-11","type":"ESTIMATED"},"lastUpdateSubmitDate":"2010-09-02","lastUpdatePostDateStruct":{"date":"2010-09-08","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Chief Medical Officer","oldOrganization":"Eli Lilly"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression."},"conditionsModule":{"conditions":["Depressive Disorder, Major"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":242,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","description":"Patients who met criteria in Study Period I (screening) were treated with duloxetine 60 milligrams (mg) once daily (QD) in an open-label manner for 4 weeks (Study Period II). Study Period II was considered the acute therapy period. Study Period III was a 4-week interval where patients who did not respond during Study Period II had their duloxetine doses optimized to 120 mg.","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks.\n\nStudy Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.","armGroupLabels":["Duloxetine"],"otherNames":["LY248686","Cymbalta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks","description":"BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a \\>=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 4 weeks"}],"secondaryOutcomes":[{"measure":"Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks","description":"The Maier subscale (Items 1,2,7,8,9,10) represents the \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a \\>=50% reduction in the Maier subscale score from baseline.","timeFrame":"Baseline, 4 weeks, 8 weeks"},{"measure":"Change From Baseline HAMD-17 Total Score at 8 Weeks","description":"The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline HAMD-17 Core Subscale at 8 Weeks","description":"The Core subscale (Items 1,2,3,7,8) evaluates \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline HAMD-17 Maier Subscale at 8 Weeks","description":"The Maier subscale (Items 1,2,7,8,9,10) represents the \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks","description":"The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks","description":"The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks","description":"The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks","description":"The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks","description":"A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 8 weeks"},{"measure":"Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks","description":"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"8 weeks"},{"measure":"Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks","description":"A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores \\<=47 (men) and \\<=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section.","timeFrame":"Baseline, 4 Weeks, 8 weeks"},{"measure":"Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks","description":"The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 4 weeks, 8 weeks"},{"measure":"Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks","description":"The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","timeFrame":"Baseline, 4 weeks, 8 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female outpatients aged 18 years or older who meet criteria for Major Depressive Disorder (MDD).\n* Currently receiving a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) class of antidepressant for at least a month for the treatment of depression.\n* Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) to test negative for pregnancy based on a urine pregnancy test and to agree to use a reliable method of birth control.\n\nExclusion Criteria:\n\n* Women who are pregnant or plan to be pregnant or are breastfeeding.\n* To have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication.\n* Diagnosed with treatment resistant depression.\n* History of bipolar disorder, schizophrenia, or other psychotic disorders.\n* To have previously taken duloxetine that didn't work.\n* Judged to be at serious suicidal risk in the opinion of the investigator and/or score \\>=3 on Item 3 (suicide) of the 17-Item Hamilton Depression Rating Scale (HAMD-17) at screening (Visit 1) or baseline (Visit 2).\n* A serious medical illness that may need treatment during the study.\n* Taking certain medications that are not allowed in this study.\n* To have a history of alcohol and/or drug abuse or dependence within the past year.\n* To have uncontrolled narrow-angle glaucoma.\n* To have allergic reactions to many medicines.\n* To have undergone \"shock\" therapy (Electroconvulsive Therapy) or \"magnet\" treatment (Transcranial Magnetic Stimulation) within the past year.\n* To initiate \"talk therapy\" (psychotherapy) just before or during the study.\n* To have chronic pain and you have been taking medicine for it for the last 6 months.\n* To have certain liver diseases.\n* To have kidney disease or undergoing dialysis.\n* Abnormal thyroid stimulating hormone (TSH) concentration.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 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":"Guri-si","zip":"471-701","country":"South Korea","geoPoint":{"lat":37.5986,"lon":127.1394}},{"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":"Seoul","zip":"136 705","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Lilly Clinical Trial Registry","url":"http://www.lillytrials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"270 participants began the study. 26 were screen failures (17 did not meet entry criteria, 7 decided to withdraw, and 2 withdrew based on the physician's decision). 2 participants discontinued before enrollment (1 was lost to follow-up and 1 decided to withdraw).","groups":[{"id":"FG000","title":"Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"FG001","title":"Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"FG002","title":"Unclassified","description":"Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status."}],"periods":[{"title":"Period II","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"115"},{"groupId":"FG001","numSubjects":"91"},{"groupId":"FG002","comment":"1 participant did not receive study drug and was not included in the safety analyses.","numSubjects":"36"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"115"},{"groupId":"FG001","numSubjects":"91"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"36"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"15"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"11"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}]}]},{"title":"Period III","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"115 reported at Week 4; 113 started Period 3 (1 lost to follow-up and 1 protocol violation).","numSubjects":"113"},{"groupId":"FG001","comment":"91 reported at Week 4; 88 start Period 3 (1 adverse event, 1 protocol violation, 1 lack of efficacy)","numSubjects":"88"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","comment":"82 participants were reported at Week 8; 81 completed Week 8 as 1 participant decided to withdraw.","numSubjects":"81"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"BG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"BG002","title":"Unclassified","description":"Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status."},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"115"},{"groupId":"BG001","value":"91"},{"groupId":"BG002","value":"36"},{"groupId":"BG003","value":"242"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"43.5","spread":"12.9"},{"groupId":"BG001","value":"45.6","spread":"12.5"},{"groupId":"BG002","value":"47.4","spread":"10.6"},{"groupId":"BG003","value":"44.9","spread":"12.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"88"},{"groupId":"BG001","value":"64"},{"groupId":"BG002","value":"30"},{"groupId":"BG003","value":"182"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"6"},{"groupId":"BG003","value":"60"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Caucasian","categories":[{"measurements":[{"groupId":"BG000","value":"67"},{"groupId":"BG001","value":"66"},{"groupId":"BG002","value":"17"},{"groupId":"BG003","value":"150"}]}]},{"title":"East Asian","categories":[{"measurements":[{"groupId":"BG000","value":"43"},{"groupId":"BG001","value":"23"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"78"}]}]},{"title":"African","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"3"}]}]},{"title":"Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"7"}]}]},{"title":"West Asian","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Korea, Republic of","categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"38"}]}]},{"title":"Brazil","categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"13"},{"groupId":"BG003","value":"33"}]}]},{"title":"China","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"3"},{"groupId":"BG003","value":"41"}]}]},{"title":"Canada","categories":[{"measurements":[{"groupId":"BG000","value":"63"},{"groupId":"BG001","value":"56"},{"groupId":"BG002","value":"11"},{"groupId":"BG003","value":"130"}]}]}]},{"title":"Had Major Depressive Disorder (MDD) Hospitalizations in the Past 24 Months","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"15"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"107"},{"groupId":"BG001","value":"86"},{"groupId":"BG002","value":"34"},{"groupId":"BG003","value":"227"}]}]}]},{"title":"Had Previous MDD in the Past 24 Months","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"79"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"24"},{"groupId":"BG003","value":"157"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"12"},{"groupId":"BG003","value":"85"}]}]}]},{"title":"Had at Least One Historical Illness","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Yes","categories":[{"measurements":[{"groupId":"BG000","value":"44"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"15"},{"groupId":"BG003","value":"91"}]}]},{"title":"No","categories":[{"measurements":[{"groupId":"BG000","value":"71"},{"groupId":"BG001","value":"59"},{"groupId":"BG002","value":"21"},{"groupId":"BG003","value":"151"}]}]}]},{"title":"Previous Treatment","description":"Previous selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) treatment.","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"SSRI","categories":[{"measurements":[{"groupId":"BG000","value":"83"},{"groupId":"BG001","value":"69"},{"groupId":"BG002","value":"25"},{"groupId":"BG003","value":"177"}]}]},{"title":"SNRI","categories":[{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"61"}]}]},{"title":"Missing or Unknown","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"},{"groupId":"BG003","value":"4"}]}]}]},{"title":"17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Score","description":"The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.7","spread":"2.1"},{"groupId":"BG001","value":"8.0","spread":"2.0"},{"groupId":"BG002","value":"7.4","spread":"1.7"},{"groupId":"BG003","value":"7.8","spread":"2.0"}]}]}]},{"title":"17-Item Hamilton Depression Rating Scale (HAMD-17) Core Score","description":"The Core subscale (Items 1,2,3,7,8) evaluates \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"8.1","spread":"2.6"},{"groupId":"BG001","value":"9.0","spread":"2.6"},{"groupId":"BG002","value":"7.9","spread":"2.8"},{"groupId":"BG003","value":"8.4","spread":"2.7"}]}]}]},{"title":"17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Score","description":"The Maier subscale (Items 1,2,7,8,9,10) represents the \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"10.7","spread":"2.6"},{"groupId":"BG001","value":"11.7","spread":"2.6"},{"groupId":"BG002","value":"10.0","spread":"2.7"},{"groupId":"BG003","value":"11.0","spread":"2.7"}]}]}]},{"title":"17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation Score","description":"The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"7.1","spread":"2.1"},{"groupId":"BG001","value":"8.2","spread":"1.9"},{"groupId":"BG002","value":"7.2","spread":"2.4"},{"groupId":"BG003","value":"7.5","spread":"2.1"}]}]}]},{"title":"17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Score","description":"The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.1","spread":"1.6"},{"groupId":"BG001","value":"3.4","spread":"1.4"},{"groupId":"BG002","value":"3.2","spread":"1.7"},{"groupId":"BG003","value":"3.2","spread":"1.5"}]}]}]},{"title":"17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score","description":"The HAMD-17 measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"21.3","spread":"4.5"},{"groupId":"BG001","value":"23.3","spread":"4.5"},{"groupId":"BG002","value":"20.7","spread":"4.5"},{"groupId":"BG003","value":"21.9","spread":"4.6"}]}]}]},{"title":"Age of First Episode of MDD","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"35.2","spread":"11.7"},{"groupId":"BG001","value":"33.5","spread":"13.6"},{"groupId":"BG002","value":"36.9","spread":"12.8"},{"groupId":"BG003","value":"34.8","spread":"12.6"}]}]}]},{"title":"Brief Pain Inventory - Short Form (BPI-SF) Average Pain Score","description":"A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.7","spread":"1.9"},{"groupId":"BG001","value":"5.0","spread":"2.0"},{"groupId":"BG002","value":"4.4","spread":"2.2"},{"groupId":"BG003","value":"4.8","spread":"2.0"}]}]}]},{"title":"Brief Pain Inventory - Short Form Interference Score","description":"The BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.2","spread":"1.6"},{"groupId":"BG001","value":"5.9","spread":"1.8"},{"groupId":"BG002","value":"5.2","spread":"1.9"},{"groupId":"BG003","value":"5.5","spread":"1.8"}]}]}]},{"title":"Changes in Sexual Function Questionnaire (CSFQ)","description":"A 14-item patient-rated scale designed to assess medication-related changes in sexual activity/functioning. Items are rated from 1 (never, low enjoyment or pleasure) to 5 (every day/great enjoyment or pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. CSFQ total score is obtained across all 5 dimensions. Lower scores are associated with sexual dysfunction/diminished sexual functioning. Total scores \\<=47 (men) and \\<=41 (women) indicate global sexual dysfunction, with all phases of the sexual response cycle being affected.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"35.3","spread":"10.3"},{"groupId":"BG001","value":"35.4","spread":"9.8"},{"groupId":"BG002","value":"33.8","spread":"9.4"},{"groupId":"BG003","value":"35.1","spread":"10.0"}]}]}]},{"title":"Clinical Global Impressions - Severity (CGI-Severity) Score","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"4.2","spread":"0.6"},{"groupId":"BG001","value":"4.4","spread":"0.6"},{"groupId":"BG002","value":"4.3","spread":"0.7"},{"groupId":"BG003","value":"4.3","spread":"0.6"}]}]}]},{"title":"Duration of the Current Episode","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"days","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"249.4","spread":"378.3"},{"groupId":"BG001","value":"264.5","spread":"318.1"},{"groupId":"BG002","value":"194.1","spread":"182.6"},{"groupId":"BG003","value":"247.3","spread":"333.3"}]}]}]},{"title":"Hamilton Anxiety Rating Scale (HAMA) Total Score","description":"The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"17.9","spread":"6.8"},{"groupId":"BG001","value":"21.4","spread":"6.8"},{"groupId":"BG002","value":"17.9","spread":"7.6"},{"groupId":"BG003","value":"19.2","spread":"7.1"}]}]}]},{"title":"Number of MDD Hospitalizations in the Past 24 Months","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"hospitalizations","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.0","spread":"0.0"},{"groupId":"BG001","value":"1.0","spread":"0.0"},{"groupId":"BG002","value":"1.0","spread":"0.0"},{"groupId":"BG003","value":"1.0","spread":"0.0"}]}]}]},{"title":"Number of Previous MDD Episodes in the Past 24 Months","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"MDD episodes","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1.6","spread":"0.8"},{"groupId":"BG001","value":"1.5","spread":"0.7"},{"groupId":"BG002","value":"1.8","spread":"1.5"},{"groupId":"BG003","value":"1.6","spread":"0.9"}]}]}]},{"title":"Sheehan Disability Scale (SDS)","description":"The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.4","spread":"2.9"},{"groupId":"BG001","value":"6.3","spread":"3.0"},{"groupId":"BG002","value":"5.5","spread":"3.0"},{"groupId":"BG003","value":"5.7","spread":"3.0"}]}]}]},{"title":"Treatment Satisfaction Questionnaire for Medication (TSQM)","description":"The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied).","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.2","spread":"17.6"},{"groupId":"BG001","value":"41.6","spread":"18.2"},{"groupId":"BG002","value":"47.2","spread":"20.8"},{"groupId":"BG003","value":"43.7","spread":"18.3"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks","description":"BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a \\>=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 4 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.35","lowerLimit":"-2.83","upperLimit":"-1.87"},{"groupId":"OG001","value":"-1.69","lowerLimit":"-2.18","upperLimit":"1.21"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.12","ciUpperLimit":"-0.20","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks","description":"The Maier subscale (Items 1,2,7,8,9,10) represents the \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a \\>=50% reduction in the Maier subscale score from baseline.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"Percentage of participants","timeFrame":"Baseline, 4 weeks, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks. Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"193"}]}],"classes":[{"title":"Week 4 (n=193)","categories":[{"measurements":[{"groupId":"OG000","value":"56.0","lowerLimit":"48.7","upperLimit":"63.1"}]}]},{"title":"Week 8 (n=179)","categories":[{"measurements":[{"groupId":"OG000","value":"73.7","lowerLimit":"66.7","upperLimit":"80.0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline HAMD-17 Total Score at 8 Weeks","description":"The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-15.64","lowerLimit":"-16.86","upperLimit":"-14.41"},{"groupId":"OG001","value":"-9.79","lowerLimit":"-11.10","upperLimit":"-8.47"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-5.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-7.34","ciUpperLimit":"-4.36","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline HAMD-17 Core Subscale at 8 Weeks","description":"The Core subscale (Items 1,2,3,7,8) evaluates \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.87","lowerLimit":"-7.41","upperLimit":"-6.33"},{"groupId":"OG001","value":"-4.40","lowerLimit":"-4.99","upperLimit":"-3.81"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-2.47","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.13","ciUpperLimit":"-1.81","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline HAMD-17 Maier Subscale at 8 Weeks","description":"The Maier subscale (Items 1,2,7,8,9,10) represents the \"core\" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-8.58","lowerLimit":"-9.25","upperLimit":"-7.90"},{"groupId":"OG001","value":"-5.29","lowerLimit":"-6.01","upperLimit":"-4.56"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-3.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-4.10","ciUpperLimit":"-2.48","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks","description":"The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.29","lowerLimit":"-5.84","upperLimit":"-4.73"},{"groupId":"OG001","value":"-3.07","lowerLimit":"-3.68","upperLimit":"-2.47"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-2.22","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.89","ciUpperLimit":"-1.54","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks","description":"The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-5.51","lowerLimit":"-5.98","upperLimit":"-5.05"},{"groupId":"OG001","value":"-3.63","lowerLimit":"-4.14","upperLimit":"-3.13"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-1.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.45","ciUpperLimit":"-1.30","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks","description":"The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.27","lowerLimit":"-2.59","upperLimit":"-1.96"},{"groupId":"OG001","value":"-1.31","lowerLimit":"-1.64","upperLimit":"-0.97"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-0.97","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.31","ciUpperLimit":"-0.63","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks","description":"The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-12.97","lowerLimit":"-14.37","upperLimit":"-11.56"},{"groupId":"OG001","value":"-8.55","lowerLimit":"-10.04","upperLimit":"-7.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-4.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-6.04","ciUpperLimit":"-2.80","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.52","lowerLimit":"-2.75","upperLimit":"-2.30"},{"groupId":"OG001","value":"-1.40","lowerLimit":"-1.65","upperLimit":"-1.14"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-1.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.42","ciUpperLimit":"-0.84","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks","description":"A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"Baseline, 8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III)."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"108"},{"groupId":"OG001","value":"85"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.56","lowerLimit":"-3.13","upperLimit":"-1.99"},{"groupId":"OG001","value":"-2.14","lowerLimit":"-2.75","upperLimit":"-1.53"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Adjusted Repeated Measures Analysis","statisticalComment":"Model terms: baseline score \\& CGI, age, sex, country, prev treatment, prev treatment discontinuation reason, response group, visit \\& response-by-visit","paramType":"Mean Difference (Final Values)","paramValue":"-0.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.08","ciUpperLimit":"-0.24","estimateComment":"Least Squares Mean Difference = Responders - Non-Responders."}]},{"type":"SECONDARY","title":"Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks","description":"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.","populationDescription":"Efficacy Population: Participants who had at least one post-baseline observation were included in the efficacy analysis. The group \"Unclassified\" was excluded from statistical testing.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"Units on a scale","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Duloxetine Responders","description":"60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III)."},{"id":"OG001","title":"Duloxetine Non-Responders","description":"60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). 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