{"protocolSection":{"identificationModule":{"nctId":"NCT00406848","orgStudyIdInfo":{"id":"10815"},"secondaryIdInfos":[{"id":"F1J-US-HMFA","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"A Study Comparing the Efficacy and Safety of Duloxetine and Placebo for the Treatment of Depression in Elderly Patients","officialTitle":"Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression"},"statusModule":{"statusVerifiedDate":"2010-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-11"},"primaryCompletionDateStruct":{"date":"2009-07","type":"ACTUAL"},"completionDateStruct":{"date":"2009-11","type":"ACTUAL"},"studyFirstSubmitDate":"2006-11-29","studyFirstSubmitQcDate":"2006-11-29","studyFirstPostDateStruct":{"date":"2006-12-04","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-07-22","resultsFirstSubmitQcDate":"2010-09-13","resultsFirstPostDateStruct":{"date":"2010-09-29","type":"ESTIMATED"},"lastUpdateSubmitDate":"2010-09-13","lastUpdatePostDateStruct":{"date":"2010-09-29","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Chief Medical Officer","oldOrganization":"Eli Lilly"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"},"collaborators":[{"name":"Boehringer Ingelheim","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to compare the efficacy and safety of duloxetine 60 mg once daily to placebo on depression in elderly patients (greater than or equal to 65 years of age). Patients who do not respond in the first 13 weeks will be eligible for rescue using pre-defined criteria. Patients randomized to duloxetine 60 mg/day meeting the rescue criteria will be increased to 120 mg/day. Patients randomized to the placebo arm meeting the rescue criteria will be assigned to duloxetine 60 mg/day."},"conditionsModule":{"conditions":["Major Depressive Disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":370,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","interventionNames":["Drug: duloxetine hydrochloride"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"duloxetine hydrochloride","description":"Placebo for 1 week (double-blind placebo lead-in), then duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.","armGroupLabels":["Duloxetine"],"otherNames":["LY248686, Cymbalta"]},{"type":"DRUG","name":"placebo","description":"Placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale","description":"The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).","timeFrame":"baseline (Week 1), Week 13"}],"secondaryOutcomes":[{"measure":"Change From Baseline on the 30-item Geriatric Depression Scale (GDS)","description":"The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression).","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items","description":"Total Score assess depression severity (scores 0-52). Core, Maier and Bech subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier; 0-22=Bech). Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher numbers indicate more severe symptoms.","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores","description":"The Brief Pain Inventory (severity and interference scales) (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores","description":"Numeric Rating Scales (Semantic Differential Scales) for Pain are 6 self-administered scales that assesses experience of overall pain, back pain, headache, shoulder pain, time in pain while awake, and pain interference with daily activities, during the past week. Each item is scored on a numeric 11-point semantic differential scale (0-10) from 0 = no pain to 10 = pain as severe as you can imagine; or 0 = none of the time to 10 = all of the time; or 0 = no interference to 10 = unable to do any activities at all.","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks","description":"The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is \"very much improved,\" a score of 4 indicates that the patient has experienced \"no change,\" and a score of 7 indicates that the patient is \"very much worse.\"","timeFrame":"Week 13, Week 25"},{"measure":"Change From Baseline in the Clinical Global Impression-Severity (CGI-S)","description":"Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Change From Baseline in the Mini-Mental State Exam (MMSE)","description":"Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. Scores range from 0 to 30. The MMSE will be used to categorize patients as with or without dementia. Higher number indicates better cognitive ability. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia.","timeFrame":"baseline (Week 1), Week 9, Week 25"},{"measure":"Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF)","description":"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) measures the degree of enjoyment and satisfaction experienced in various areas of daily life. The short version is a self-administered 16 item scale evaluating satisfaction of general activities on a 5-point Likert scale that indicates the degree of enjoyment or satisfaction achieved during the past week (1 = very poor and 5 = very good).","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10","description":"Remission (visitwise binary outcome, yes/no) is defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for remission (either Total Score ≤7 or ≤10) was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.","timeFrame":"Week 13, Week 25"},{"measure":"Probability of Response at Endpoint as Measured by ≥50% Improvement in the HAMD-17 Total Score","description":"Response (visitwise binary outcome, yes/no) is defined as ≥ 50% reduction from baseline in the HAMD-17 total score. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for response was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.","timeFrame":"Week 13, Week 25"},{"measure":"Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 by Medical Comorbidity Severity as Assessed by the Cumulative Illness Rating Scale-Geriatric Version (CIRS-G)","description":"Remission defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. Total score ranges: 0 (normal) to 52 (severe depression). Visitwise probability of patients achieving remission was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. CIRS-G evaluates 14 organ-specific categories using a rating strategy of 0=no problems; 1=current mild problem/past significant problem; 2=moderate disability/morbidity; 3=severe/constant significant disability; and 4=extremely severe/immediate treatment required/end organ failure. Total score ranges: 0 to 56.","timeFrame":"Week 13, Week 25"},{"measure":"Probability of Efficacy Onset as Measured by at Least 20% Sustained Reduction From Baseline in the HAMD-17 Maier Subscale at Week 3","description":"Patients are considered to have met onset (visitwise binary outcome, yes/no) criteria at a particular visit if they had at least 20% reduction from baseline in the HAMD-17 Maier subscale at that visit and at all subsequent visits in the acute phase. Maier subscale measures core symptoms of depression and scores range from 0 (normal) to 24 (severe). The visitwise probability of patients meeting onset criteria was analyzed using a categorical, pseudo-likelihood-based repeated measures approach.","timeFrame":"Week 3"},{"measure":"Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Change From Baseline in Pulse Rate","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Change From Baseline in Weight","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Number of Participants With Abnormal Vital Signs and Weight at Any Time During the Study","description":"A patient has a treatment-emergent elevated supine systolic blood pressure if the value is ≥140 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine diastolic blood pressure if the value is ≥90 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine pulse if the value is ≥100 with an increase ≥10 from baseline.\n\nA patient has abnormal weight change if the gain or loss is ≥7% compared to baseline.","timeFrame":"Baseline (Week 1) through Week 25"},{"measure":"Number of Participants Experiencing Sustained Hypertension (SH) or Orthostatic Hypotension (OH)","description":"Sustained Hypertension is defined as supine systolic BP \\>= 140 (or diastolic BP \\>= 90) mm Hg and increase from baseline (highest value in baseline visit interval) \\>= 10 mm Hg for 3 or more consecutive visits in postbaseline visit interval. Orthostatic Hypotension is defined as standing diastolic BP at least 10 mm Hg less than the supine diastolic BP or the standing systolic BP at least 20 mm Hg less than the supine systolic BP at any time in postbaseline visit interval and a patient does not meet this criterion at any visit in baseline interval.","timeFrame":"baseline (Week 1) through Week 25"},{"measure":"Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation","description":"Adverse Events and Serious Adverse Events leading to study discontinuation.","timeFrame":"baseline (Week 1) through Week 25"},{"measure":"Change From Baseline in Laboratory Values - Platelet Count","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Change From Baseline in Laboratory Values - Uric Acid","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","timeFrame":"baseline (Week 1), Week 13, Week 25"},{"measure":"Change From Baseline in Laboratory Values - Erythrocyte Count","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","timeFrame":"baseline (Week 1), Week 25"},{"measure":"Change From Baseline in Laboratory Values - Hemoglobin, Mean Cell Hemoglobin Concentration (MCHC)","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","timeFrame":"baseline (Week 1), Week 25"},{"measure":"Change From Baseline in Laboratory Values - Chloride and Fasting Glucose","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","timeFrame":"baseline (Week 1), Week 25"},{"measure":"Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count","description":"The number of participants with abnormal laboratory values at any time during the study period. Results are reported for laboratory analytes that exhibited statistically significantly different proportions of participants who had abnormal values between treatment groups. Statistical significance was considered at the 0.05 level. The lower limit of normal for leukocyte count is 3.8 Billion/Liter. Participants who had a value below that number were considered to have abnormally low leukocyte count.","timeFrame":"baseline (Week 1) through Week 13"},{"measure":"Change From Baseline in Electrocardiograms","description":"The Electrocardiogram measures include the following time intervals: QT interval, QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB), PR interval and QRS interval.","timeFrame":"baseline (Week 1), Week 25"},{"measure":"Number of Participants With Successful Treatment Outcome","description":"Successful treatment outcome defined as: Participant completed the study and being in remission (HAMD-17 Total score ≤7 and ≤10) at least for the last two visits (4 weeks)of the study. The HAMD-17 is used to assess the severity of depression. The total score ranges from 0 (not at all depressed) to 52 (severely depressed).","timeFrame":"Baseline (Week 1) through Week 25"},{"measure":"Change From Baseline on Cognitive Test Scores: Verbal Learning and Recall Test (VLRT), Symbol Digit Substitution Test (SDST), Trail Making Test (Part B), 2-Digit Cancellation Test (2DCT), and the Composite Cognitive Score Derived From the Above Scores","description":"The cognitive assessment battery is composed of four tests: Verbal Learning (score 0-15)and Delayed Recall(score 0-15) test, SDST(Score 0-133),2DCT(score 0-40),Trail Making(Part B)(score 0-180).They are designed to challenge the patient's abilities in the following areas: verbal learning and memory; attention to visually presented material; and working memory and executive function. Composite Cognitive score(0-51)is derived from normalized individual test scores. For Trail Making Test,lower number indicates better cognition. For all other test scores,higher number indicates better cognition.","timeFrame":"baseline (Week 1), Week 9, Week 25"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Are male or female outpatients at least 65 years of age who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)\n* Have a Mini Mental Score Exam (MMSE) score of at least 20 at Visit 1\n* Have a degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator\n\nExclusion Criteria:\n\n* Patients judged clinically to be at serious suicidal risk in the opinion of the investigator\n* Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder\n* Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD\n* Have moderate to severe dementia\n* Have a serious medical illness, including any cardiovascular (CV), hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator","healthyVolunteers":false,"sex":"ALL","minimumAge":"65 Years","stdAges":["OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 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":"Pasadena","state":"California","zip":"91107","country":"United States","geoPoint":{"lat":34.14778,"lon":-118.14452}},{"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":"Sherman Oaks","state":"California","zip":"91403","country":"United States","geoPoint":{"lat":34.15112,"lon":-118.44925}},{"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":"Hamden","state":"Connecticut","zip":"06518","country":"United States","geoPoint":{"lat":41.39593,"lon":-72.89677}},{"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":"Coral Springs","state":"Florida","zip":"33065","country":"United States","geoPoint":{"lat":26.27119,"lon":-80.2706}},{"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":"West Palm Beach","state":"Florida","zip":"33407","country":"United States","geoPoint":{"lat":26.71534,"lon":-80.05337}},{"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":"Atlanta","state":"Georgia","zip":"30328","country":"United States","geoPoint":{"lat":33.749,"lon":-84.38798}},{"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":"Hoffman Estates","state":"Illinois","zip":"60194","country":"United States","geoPoint":{"lat":42.04281,"lon":-88.0798}},{"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":"Lake Charles","state":"Louisiana","zip":"70601","country":"United States","geoPoint":{"lat":30.21309,"lon":-93.2044}},{"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":"Gaithersburg","state":"Maryland","zip":"20877","country":"United States","geoPoint":{"lat":39.14344,"lon":-77.20137}},{"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":"Glen Burnie","state":"Maryland","zip":"21061","country":"United States","geoPoint":{"lat":39.16261,"lon":-76.62469}},{"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":"Fall River","state":"Massachusetts","zip":"02721","country":"United States","geoPoint":{"lat":41.70149,"lon":-71.15505}},{"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":"Nashua","state":"New Hampshire","zip":"03060","country":"United States","geoPoint":{"lat":42.76537,"lon":-71.46757}},{"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":"Toms River","state":"New Jersey","zip":"08755","country":"United States","geoPoint":{"lat":39.95373,"lon":-74.19792}},{"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":"Olean","state":"New York","zip":"14760","country":"United States","geoPoint":{"lat":42.07756,"lon":-78.42974}},{"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":"Staten Island","state":"New York","zip":"10312","country":"United States","geoPoint":{"lat":40.56233,"lon":-74.13986}},{"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":"Oklahoma City","state":"Oklahoma","zip":"73109","country":"United States","geoPoint":{"lat":35.46756,"lon":-97.51643}},{"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":"Philadelphia","state":"Pennsylvania","zip":"19139","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}},{"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":"Lincoln","state":"Rhode Island","zip":"02865","country":"United States","geoPoint":{"lat":41.92111,"lon":-71.435}},{"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":"Bartlett","state":"Tennessee","zip":"38134","country":"United States","geoPoint":{"lat":35.20453,"lon":-89.87398}},{"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":"Memphis","state":"Tennessee","zip":"38105","country":"United States","geoPoint":{"lat":35.14953,"lon":-90.04898}},{"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":"Wichita Falls","state":"Texas","zip":"76309","country":"United States","geoPoint":{"lat":33.91371,"lon":-98.49339}},{"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":"Charleston","state":"West Virginia","zip":"25301","country":"United States","geoPoint":{"lat":38.34982,"lon":-81.63262}},{"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":"Brown Deer","state":"Wisconsin","zip":"53223","country":"United States","geoPoint":{"lat":43.16334,"lon":-87.96453}},{"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":"Arcachon","zip":"33120","country":"France","geoPoint":{"lat":44.66126,"lon":-1.17255}},{"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":"Douai","zip":"59500","country":"France","geoPoint":{"lat":50.37069,"lon":3.07922}},{"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":"Limoges","zip":"87025","country":"France","geoPoint":{"lat":45.83362,"lon":1.24759}},{"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":"Metz","zip":"57020","country":"France","geoPoint":{"lat":49.11911,"lon":6.17269}},{"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":"Nice","zip":"06002","country":"France","geoPoint":{"lat":43.70313,"lon":7.26608}},{"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":"Strasbourg","zip":"67000","country":"France","geoPoint":{"lat":48.58392,"lon":7.74553}},{"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":"Valence","zip":"26000","country":"France","geoPoint":{"lat":44.9256,"lon":4.90956}},{"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":"Mexico City","zip":"14050","country":"Mexico","geoPoint":{"lat":19.42847,"lon":-99.12766}},{"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":"Monterrey","zip":"64710","country":"Mexico","geoPoint":{"lat":25.68435,"lon":-100.31721}},{"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":"Ponce","zip":"00731-7779","country":"Puerto Rico","geoPoint":{"lat":18.01031,"lon":-66.62398}}]},"referencesModule":{"references":[{"pmid":"25980552","type":"DERIVED","citation":"Harada E, Kato M, Fujikoshi S, Wohlreich MM, Berggren L, Tokuoka H. Changes in energy during treatment of depression: an analysis of duloxetine in double-blind placebo-controlled trials. Int J Clin Pract. 2015 Oct;69(10):1139-48. doi: 10.1111/ijcp.12658. Epub 2015 May 16."},{"pmid":"23724353","type":"DERIVED","citation":"Nelson JC, Oakes TM, Liu P, Ahl J, Bangs ME, Raskin J, Perahia DG, Robinson MJ. Assessment of falls in older patients treated with duloxetine: a secondary analysis of a 24-week randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2013;15(1):PCC.12m01419. doi: 10.4088/PCC.12m01419. Epub 2012 Jan 3."},{"pmid":"23138680","type":"DERIVED","citation":"Oakes TM, Katona C, Liu P, Robinson M, Raskin J, Greist JH. Safety and tolerability of duloxetine in elderly patients with major depressive disorder: a pooled analysis of two placebo-controlled studies. Int Clin Psychopharmacol. 2013 Jan;28(1):1-11. doi: 10.1097/YIC.0b013e32835b09cd."}],"seeAlsoLinks":[{"label":"Lilly Clinical Trial Registry","url":"http://www.lillytrials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"This study had a double-blind one-week placebo lead-in period before randomization, so baseline is defined as Week 1. 370 total patients were randomized and make up the safety analysis population. 299 of these patients were randomized under protocol amendments c, d and e, and make up the efficacy analysis population.","groups":[{"id":"FG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"FG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","comment":"Represents full safety analysis population. Efficacy analysis population (c,d,e) N=204.","numSubjects":"249"},{"groupId":"FG001","comment":"Represents full safety analysis population. Efficacy analysis population (c,d,e) N=95.","numSubjects":"121"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"156"},{"groupId":"FG001","numSubjects":"67"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"93"},{"groupId":"FG001","numSubjects":"54"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"22"}]},{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"14"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Sponsor Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"BG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"249"},{"groupId":"BG001","value":"121"},{"groupId":"BG002","value":"370"}]}],"measures":[{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"72.89","spread":"6.10"},{"groupId":"BG001","value":"73.02","spread":"5.64"},{"groupId":"BG002","value":"72.93","spread":"5.95"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"163"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"234"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"86"},{"groupId":"BG001","value":"50"},{"groupId":"BG002","value":"136"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"NUMBER","unitOfMeasure":"Participants","classes":[{"title":"African","categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"6"},{"groupId":"BG002","value":"11"}]}]},{"title":"Caucasian","categories":[{"measurements":[{"groupId":"BG000","value":"198"},{"groupId":"BG001","value":"92"},{"groupId":"BG002","value":"290"}]}]},{"title":"Hispanic","categories":[{"measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"68"}]}]},{"title":"Native American","categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"France","categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"21"}]}]},{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"195"},{"groupId":"BG001","value":"94"},{"groupId":"BG002","value":"289"}]}]},{"title":"Mexico","categories":[{"measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"25"}]}]},{"title":"Puerto Rico","categories":[{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"35"}]}]}]},{"title":"17 item Hamilton Depression Rating Scale Total Score(HAMD-17)","description":"The 17-item HAMD 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). Results shown are based on efficacy analysis population only.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"19.42","spread":"5.56"},{"groupId":"BG001","value":"19.32","spread":"5.78"},{"groupId":"BG002","value":"19.39","spread":"5.62"}]}]}]},{"title":"17 item Hamilton Depression Rating Scale (HAMD-17) - Maier subscale","description":"The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Results shown are based on efficacy analysis population only.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9.96","spread":"3.11"},{"groupId":"BG001","value":"10.08","spread":"3.36"},{"groupId":"BG002","value":"10.00","spread":"3.19"}]}]}]},{"title":"Geriatric Depression Scale (GDS) Total Score","description":"The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression). Results shown are based on efficacy analysis population only.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"18.54","spread":"6.91"},{"groupId":"BG001","value":"17.64","spread":"6.66"},{"groupId":"BG002","value":"18.26","spread":"6.83"}]}]}]},{"title":"Numerical Rating Scale (NRS) Overall Pain Score","description":"How much the participant has been bothered by pain over the last week, as measured by an 11-point Likert scale. A score of 0 reflects \"not bothered at all\" and a score of 10 reflects \"extremely bothered\". Results shown are based on efficacy analysis population only.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.79","spread":"2.96"},{"groupId":"BG001","value":"3.59","spread":"2.67"},{"groupId":"BG002","value":"3.73","spread":"2.87"}]}]}]},{"title":"Brief Pain Inventory (BPI) 24-hour Average Pain Score","description":"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Results shown are based on efficacy analysis population only.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"3.48","spread":"2.70"},{"groupId":"BG001","value":"3.48","spread":"2.57"},{"groupId":"BG002","value":"3.48","spread":"2.66"}]}]}]},{"title":"Mini Mental State Exam (MMSE) Total Score","description":"Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. The MMSE will be used to categorize patients as with or without dementia. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia. Scores range from 0 to 30. Results shown are based on efficacy analysis population only.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28.55","spread":"1.83"},{"groupId":"BG001","value":"28.42","spread":"1.72"},{"groupId":"BG002","value":"28.51","spread":"1.79"}]}]}]},{"title":"Montgomery-Asberg Depression Rating Scale (MADRS) Total Score","description":"The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Results shown are based on efficacy analysis population only.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"29.25","spread":"5.57"},{"groupId":"BG001","value":"28.46","spread":"5.40"},{"groupId":"BG002","value":"29.00","spread":"5.52"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline to 13 Weeks in Hamilton Depression Rating Scale (HAMD-17) Maier Subscale","description":"The Maier subscale (Items 1,2,7,8,9,10) represents symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 13","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"95"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-4.34","spread":"0.29"},{"groupId":"OG001","value":"-3.90","spread":"0.44"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null hypothesis that there would be no difference in changes from baseline (Week 1) to Week 13 on the HAMD-17 Maier subscale between duloxetine and placebo treatment groups.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.397","pValueComment":"The a priori threshold for statistical significance was 0.05.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline on the 30-item Geriatric Depression Scale (GDS)","description":"The 30-item Geriatric Depression Scale (GDS) is a self-administered test of 30 questions to measure the severity of depression. The yes/no questions result in a range of scores from 0 (normal) to 30 (severe depression).","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"90"}]}],"classes":[{"title":"Week 13 change","categories":[{"measurements":[{"groupId":"OG000","value":"-6.01","spread":"0.53"},{"groupId":"OG001","value":"-4.53","spread":"0.79"}]}]},{"title":"Week 25 change","categories":[{"measurements":[{"groupId":"OG000","value":"-7.02","spread":"0.58"},{"groupId":"OG001","value":"-3.66","spread":"1.00"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.115","pValueComment":"p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.004","pValueComment":"p-value is for difference between duloxetine and placebo on change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the HAMD-17 Total Score, Subscales, and Individual Items","description":"Total Score assess depression severity (scores 0-52). Core, Maier and Bech subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier; 0-22=Bech). Anxiety/Somatization subscale assesses severity of anxiety (0-18). Retardation subscale assesses dysfunction in mood and work (0-14). Sleep subscale assesses insomnia (0-6). Individual item scores may range from 0-4 or 0-2. Higher numbers indicate more severe symptoms.","populationDescription":"Randomized patients with non-missing data at baseline and post-baseline visit.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"95"}]}],"classes":[{"title":"Total - Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-7.42","spread":"0.52"},{"groupId":"OG001","value":"-7.15","spread":"0.77"}]}]},{"title":"Total - Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-8.98","spread":"0.57"},{"groupId":"OG001","value":"-7.00","spread":"1.01"}]}]},{"title":"Maier subscale Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-5.31","spread":"0.29"},{"groupId":"OG001","value":"-4.17","spread":"0.54"}]}]},{"title":"Bech subscale Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-4.35","spread":"0.30"},{"groupId":"OG001","value":"-3.98","spread":"0.46"}]}]},{"title":"Bech subscale Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-5.36","spread":"0.31"},{"groupId":"OG001","value":"-4.07","spread":"0.58"}]}]},{"title":"Core Mood subscale Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-3.29","spread":"0.24"},{"groupId":"OG001","value":"-3.02","spread":"0.36"}]}]},{"title":"Core Mood subscale Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-4.08","spread":"0.23"},{"groupId":"OG001","value":"-3.00","spread":"0.43"}]}]},{"title":"Anxiety/Somatization subscale Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-2.38","spread":"0.20"},{"groupId":"OG001","value":"-2.26","spread":"0.30"}]}]},{"title":"Anxiety/Somatization subscale Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-2.90","spread":"0.22"},{"groupId":"OG001","value":"-2.44","spread":"0.38"}]}]},{"title":"Sleep subscale Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.14","spread":"0.12"},{"groupId":"OG001","value":"-1.14","spread":"0.18"}]}]},{"title":"Sleep subscale Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.37","spread":"0.13"},{"groupId":"OG001","value":"-1.35","spread":"0.24"}]}]},{"title":"Retardation subscale Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-2.70","spread":"0.21"},{"groupId":"OG001","value":"-2.73","spread":"0.31"}]}]},{"title":"Retardation subscale Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-3.42","spread":"0.20"},{"groupId":"OG001","value":"-2.77","spread":"0.38"}]}]},{"title":"Item 1: Depressed Mood - Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.13","spread":"0.09"},{"groupId":"OG001","value":"-1.02","spread":"0.13"}]}]},{"title":"Item 1: Depressed Mood Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.36","spread":"0.09"},{"groupId":"OG001","value":"-1.02","spread":"0.16"}]}]},{"title":"Item 2: Feelings of Guilt Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.70","spread":"0.06"},{"groupId":"OG001","value":"-0.60","spread":"0.09"}]}]},{"title":"Item 2: Feelings of Guilt Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.91","spread":"0.06"},{"groupId":"OG001","value":"-0.65","spread":"0.12"}]}]},{"title":"Item 3: Suicide Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.16","spread":"0.04"},{"groupId":"OG001","value":"-0.18","spread":"0.05"}]}]},{"title":"Item 3: Suicide Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.19","spread":"0.04"},{"groupId":"OG001","value":"-0.11","spread":"0.07"}]}]},{"title":"Item 4: Insomnia Early Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.37","spread":"0.06"},{"groupId":"OG001","value":"-0.29","spread":"0.09"}]}]},{"title":"Item 4: Insomnia Early Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.42","spread":"0.06"},{"groupId":"OG001","value":"-0.41","spread":"0.12"}]}]},{"title":"Item 5: Insomnia Middle Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.40","spread":"0.06"},{"groupId":"OG001","value":"-0.47","spread":"0.09"}]}]},{"title":"Item 5: Insomnia Middle Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.49","spread":"0.06"},{"groupId":"OG001","value":"-0.46","spread":"0.11"}]}]},{"title":"Item 6: Insomnia Late Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.36","spread":"0.06"},{"groupId":"OG001","value":"-0.41","spread":"0.08"}]}]},{"title":"Item 6: Insomnia Late Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.45","spread":"0.05"},{"groupId":"OG001","value":"-0.53","spread":"0.10"}]}]},{"title":"Item 7: Work and Activities Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.82","spread":"0.08"},{"groupId":"OG001","value":"-0.81","spread":"0.12"}]}]},{"title":"Item 7: Work and Activities Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.12","spread":"0.09"},{"groupId":"OG001","value":"-0.87","spread":"0.16"}]}]},{"title":"Item 8: Retardation Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.48","spread":"0.05"},{"groupId":"OG001","value":"-0.51","spread":"0.08"}]}]},{"title":"Item 8: Retardation Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.57","spread":"0.05"},{"groupId":"OG001","value":"-0.54","spread":"0.09"}]}]},{"title":"Item 9: Agitation Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.39","spread":"0.06"},{"groupId":"OG001","value":"-0.32","spread":"0.08"}]}]},{"title":"Item 9: Agitation Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.45","spread":"0.06"},{"groupId":"OG001","value":"-0.53","spread":"0.11"}]}]},{"title":"Item 10: Anxiety/Psychic Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.81","spread":"0.07"},{"groupId":"OG001","value":"-0.75","spread":"0.11"}]}]},{"title":"Item 10: Anxiety/Psychic Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.98","spread":"0.08"},{"groupId":"OG001","value":"-0.85","spread":"0.14"}]}]},{"title":"Item 11: Anxiety (Somatic) Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.49","spread":"0.06"},{"groupId":"OG001","value":"-0.55","spread":"0.09"}]}]},{"title":"Item 11: Anxiety (Somatic) Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.70","spread":"0.06"},{"groupId":"OG001","value":"-0.60","spread":"0.11"}]}]},{"title":"Item 12: Somatic Symptom/Gastrointestinal Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.16","spread":"0.04"},{"groupId":"OG001","value":"-0.20","spread":"0.06"}]}]},{"title":"Item 12: Somatic Symptom/Gastrointestinal Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.23","spread":"0.04"},{"groupId":"OG001","value":"-0.26","spread":"0.07"}]}]},{"title":"Item 13: Somatic Symptoms/General Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.41","spread":"0.06"},{"groupId":"OG001","value":"-0.40","spread":"0.09"}]}]},{"title":"Item 13: Somatic Symptoms/General Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.52","spread":"0.07"},{"groupId":"OG001","value":"-0.59","spread":"0.13"}]}]},{"title":"Item 14: Genital Symptoms Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.29","spread":"0.06"},{"groupId":"OG001","value":"-0.46","spread":"0.08"}]}]},{"title":"Item 14: Genital Symptoms Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.41","spread":"0.06"},{"groupId":"OG001","value":"-0.47","spread":"0.12"}]}]},{"title":"Item 15: Hypochondriasis Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.47","spread":"0.06"},{"groupId":"OG001","value":"-0.32","spread":"0.08"}]}]},{"title":"Item 15: Hypochondriasis Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.49","spread":"0.06"},{"groupId":"OG001","value":"-0.39","spread":"0.11"}]}]},{"title":"Item 16: Loss of Weight Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.02","spread":"0.03"},{"groupId":"OG001","value":"-0.09","spread":"0.04"}]}]},{"title":"Item 16: Loss of Weight Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.13","spread":"0.02"},{"groupId":"OG001","value":"-0.01","spread":"0.04"}]}]},{"title":"Item 17: Insight Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.09","spread":"0.02"},{"groupId":"OG001","value":"-0.10","spread":"0.03"}]}]},{"title":"Item 17: Insight Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.07","spread":"0.03"},{"groupId":"OG001","value":"-0.11","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.773","pValueComment":"p-value is for HAMD-17 total score change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.084","pValueComment":"p-value is for HAMD-17 total score change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.059","pValueComment":"p-value is for Maier subscale change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.488","pValueComment":"p-value is for Bech subscale change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.048","pValueComment":"p-value is for HAMD-17 Bech subscale change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.529","pValueComment":"p-value is for Core Mood subscale change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.027","pValueComment":"p-value is for Core Mood subscale change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.749","pValueComment":"p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.296","pValueComment":"p-value is for Anxiety/Somatization subscale change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.984","pValueComment":"p-value is for Sleep subscale change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.930","pValueComment":"p-value is for Sleep subscale change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.934","pValueComment":"p-value is for Retardation subscale change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.123","pValueComment":"p-value is for Retardation subscale change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Brief Pain Inventory (BPI) Severity and Interference Scores","description":"The Brief Pain Inventory (severity and interference scales) (BPI) is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"87"}]}],"classes":[{"title":"Worst Pain - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.66","spread":"0.14"},{"groupId":"OG001","value":"-0.18","spread":"0.19"}]}]},{"title":"Worst Pain - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.74","spread":"0.14"},{"groupId":"OG001","value":"-0.36","spread":"0.20"}]}]},{"title":"Least Pain - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.47","spread":"0.11"},{"groupId":"OG001","value":"-0.00","spread":"0.15"}]}]},{"title":"Least Pain - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.54","spread":"0.11"},{"groupId":"OG001","value":"-0.26","spread":"0.16"}]}]},{"title":"Average Pain - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.83","spread":"0.13"},{"groupId":"OG001","value":"-0.14","spread":"0.18"}]}]},{"title":"Average Pain - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.87","spread":"0.12"},{"groupId":"OG001","value":"-0.37","spread":"0.18"}]}]},{"title":"Pain Right Now - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.78","spread":"0.13"},{"groupId":"OG001","value":"-0.26","spread":"0.18"}]}]},{"title":"Pain Right Now - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.86","spread":"0.13"},{"groupId":"OG001","value":"-0.46","spread":"0.18"}]}]},{"title":"Interference with General Activity - Week13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.58","spread":"0.13"},{"groupId":"OG001","value":"-0.03","spread":"0.19"}]}]},{"title":"Interference with General Activity - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.65","spread":"0.13"},{"groupId":"OG001","value":"-0.23","spread":"0.19"}]}]},{"title":"Interference with Mood - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.82","spread":"0.14"},{"groupId":"OG001","value":"-0.03","spread":"0.19"}]}]},{"title":"Interference with Mood - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.95","spread":"0.13"},{"groupId":"OG001","value":"-0.25","spread":"0.19"}]}]},{"title":"Interference with Walking Ability - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.74","spread":"0.14"},{"groupId":"OG001","value":"-0.19","spread":"0.20"}]}]},{"title":"Interference with Walking Ability - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.75","spread":"0.15"},{"groupId":"OG001","value":"-0.24","spread":"0.21"}]}]},{"title":"Interference with Normal Work - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.72","spread":"0.15"},{"groupId":"OG001","value":"-0.01","spread":"0.21"}]}]},{"title":"Interference with Normal Work - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.79","spread":"0.15"},{"groupId":"OG001","value":"-0.19","spread":"0.21"}]}]},{"title":"Int. with Relations with other people- Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.60","spread":"0.13"},{"groupId":"OG001","value":"-0.03","spread":"0.19"}]}]},{"title":"Int. with Relations with other people-Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.73","spread":"0.13"},{"groupId":"OG001","value":"-0.18","spread":"0.19"}]}]},{"title":"Interference with Sleep - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.77","spread":"0.15"},{"groupId":"OG001","value":"-0.17","spread":"0.21"}]}]},{"title":"Interference with Sleep - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.94","spread":"0.14"},{"groupId":"OG001","value":"-0.26","spread":"0.21"}]}]},{"title":"Interference with Enjoyment of Life- Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.93","spread":"0.15"},{"groupId":"OG001","value":"0.03","spread":"0.21"}]}]},{"title":"Interference with Enjoyment of Life- Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-1.04","spread":"0.15"},{"groupId":"OG001","value":"-0.08","spread":"0.21"}]}]},{"title":"Average Interference Score - Week 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treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.009","pValueComment":"p-value is for Severity of Least Pain Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.126","pValueComment":"p-value is for Severity of Least Pain Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated 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Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.011","pValueComment":"p-value is for Interference with General Activity Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.060","pValueComment":"p-value is for Interference with General Activity Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"p-value is for Interference with Mood Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","pValueComment":"p-value is for Interference with Mood Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.019","pValueComment":"p-value is for Interference with Walking Ability Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.040","pValueComment":"p-value is for Interference with Walking Ability Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","pValueComment":"p-value is for Interference with Normal Work Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.014","pValueComment":"p-value is for Interference with Normal Work Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.010","pValueComment":"p-value is for Interference with Relations with Other People Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.010","pValueComment":"p-value is for Interference with Relations with Other People Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.015","pValueComment":"p-value is for Interference with Sleep Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","pValueComment":"p-value is for Interference with Sleep Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"p-value is for Interference with Enjoyment of Life Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"p-value is for Interference with Enjoyment of Life Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"p-value is for Average Interference Score Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","pValueComment":"p-value is for Average Interference Score Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Numeric Rating Scales (NRS) for Pain Item Scores","description":"Numeric Rating Scales (Semantic Differential Scales) for Pain are 6 self-administered scales that assesses experience of overall pain, back pain, headache, shoulder pain, time in pain while awake, and pain interference with daily activities, during the past week. Each item is scored on a numeric 11-point semantic differential scale (0-10) from 0 = no pain to 10 = pain as severe as you can imagine; or 0 = none of the time to 10 = all of the time; or 0 = no interference to 10 = unable to do any activities at all.","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"191"},{"groupId":"OG001","value":"87"}]}],"classes":[{"title":"Overall Pain - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.65","spread":"0.13"},{"groupId":"OG001","value":"-0.05","spread":"0.18"}]}]},{"title":"Overall Pain - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.67","spread":"0.13"},{"groupId":"OG001","value":"-0.40","spread":"0.19"}]}]},{"title":"Headaches - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.32","spread":"0.12"},{"groupId":"OG001","value":"0.01","spread":"0.16"}]}]},{"title":"Headaches - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.28","spread":"0.12"},{"groupId":"OG001","value":"0.01","spread":"0.18"}]}]},{"title":"Back Pain - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.63","spread":"0.14"},{"groupId":"OG001","value":"0.00","spread":"0.20"}]}]},{"title":"Back Pain - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.75","spread":"0.14"},{"groupId":"OG001","value":"-0.15","spread":"0.21"}]}]},{"title":"Shoulder Pain - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.54","spread":"0.12"},{"groupId":"OG001","value":"-0.22","spread":"0.17"}]}]},{"title":"Shoulder Pain - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.55","spread":"0.13"},{"groupId":"OG001","value":"-0.30","spread":"0.18"}]}]},{"title":"Pain Interference with Daily Activities - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.84","spread":"0.14"},{"groupId":"OG001","value":"-0.20","spread":"0.20"}]}]},{"title":"Pain Interference with Daily Activities - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-0.91","spread":"0.15"},{"groupId":"OG001","value":"-0.34","spread":"0.21"}]}]},{"title":"Time in Pain While Awake - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"-0.75","spread":"0.14"},{"groupId":"OG001","value":"-0.04","spread":"0.19"}]}]},{"title":"Time in Pain While Awake - Week 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Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.078","pValueComment":"p-value is for Headaches Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.147","pValueComment":"p-value is for Headaches Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.007","pValueComment":"p-value is for Back Pain Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.013","pValueComment":"p-value is for Back Pain Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.124","pValueComment":"p-value is for Shoulder Pain Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.231","pValueComment":"p-value is for Shoulder Pain Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.006","pValueComment":"p-value is for Interference with Daily Activities Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.019","pValueComment":"p-value is for Interference with Daily Activities Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","pValueComment":"p-value is for Time in Pain While Awake Week 13 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.036","pValueComment":"p-value is for Time in Pain While Awake Week 25 main effect of treatment.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Patient's Global Impression of Improvement (PGI-I) at 13 Weeks and 25 Weeks","description":"The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is \"very much improved,\" a score of 4 indicates that the patient has experienced \"no change,\" and a score of 7 indicates that the patient is \"very much worse.\"","populationDescription":"All participants randomized under protocol amendment c,d,e, and have at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"178"},{"groupId":"OG001","value":"84"}]}],"classes":[{"title":"Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"2.74","spread":"0.13"},{"groupId":"OG001","value":"3.02","spread":"0.19"}]}]},{"title":"Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"2.38","spread":"0.12"},{"groupId":"OG001","value":"2.85","spread":"0.23"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.214","pValueComment":"p-value is for PGI-I at Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\\* Visit","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".063","pValueComment":"p-value is for PGI-I at Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: PGI-I = Treatment + Pooled Investigator + Visit + Treatment\\* Visit","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Clinical Global Impression-Severity (CGI-S)","description":"Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"203"},{"groupId":"OG001","value":"94"}]}],"classes":[{"title":"Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.25","spread":"0.09"},{"groupId":"OG001","value":"-1.04","spread":"0.13"}]}]},{"title":"Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.65","spread":"0.09"},{"groupId":"OG001","value":"-1.17","spread":"0.16"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".162","pValueComment":"p-value is for change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".009","pValueComment":"p-value is for change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change =Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Mini-Mental State Exam (MMSE)","description":"Mini-Mental State Examination (MMSE)is a widely used rating measure of cognitive ability. Scores range from 0 to 30. The MMSE will be used to categorize patients as with or without dementia. Higher number indicates better cognitive ability. Patients with a MMSE score of 20 to 23 will be categorized as having mild dementia, while those with a score of ≥ 24 will be categorized as having no dementia.","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 9, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"69"}]}],"classes":[{"title":"Week 9 Change (n=159, n=69)","categories":[{"measurements":[{"groupId":"OG000","value":"0.12","spread":"0.13"},{"groupId":"OG001","value":"0.24","spread":"0.18"}]}]},{"title":"Week 25 Change (n=161, n=71)","categories":[{"measurements":[{"groupId":"OG000","value":"0.29","spread":"0.13"},{"groupId":"OG001","value":"0.35","spread":"0.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.555","pValueComment":"p-value is for change from baseline (Week 1) to Week 9.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change = Treatment + Pooled Investigator + Baseline","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".785","pValueComment":"p-value is for change from baseline (Week 1) to Week 25.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change = Treatment + Pooled Investigator + Baseline","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q-SF)","description":"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF) measures the degree of enjoyment and satisfaction experienced in various areas of daily life. The short version is a self-administered 16 item scale evaluating satisfaction of general activities on a 5-point Likert scale that indicates the degree of enjoyment or satisfaction achieved during the past week (1 = very poor and 5 = very good).","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"167"},{"groupId":"OG001","value":"82"}]}],"classes":[{"title":"Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"6.58","spread":"0.71"},{"groupId":"OG001","value":"5.27","spread":"0.98"}]}]},{"title":"Week 25 Change (n=168, n=82)","categories":[{"measurements":[{"groupId":"OG000","value":"7.44","spread":"0.78"},{"groupId":"OG001","value":"4.79","spread":"1.08"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.255","pValueComment":"p-value is for change from baseline (Week 1) to Week 13.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change = Treatment + Pooled Investigator + Baseline","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.038","pValueComment":"p-value is for change from baseline (Week 1) to Week 25.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change = Treatment + Pooled Investigator + Baseline","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10","description":"Remission (visitwise binary outcome, yes/no) is defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for remission (either Total Score ≤7 or ≤10) was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"probability of remission","timeFrame":"Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"95"}]}],"classes":[{"title":"Remission (HAMD17 ≤ 7) - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"0.37","spread":"0.26"},{"groupId":"OG001","value":"0.33","spread":"0.42"}]}]},{"title":"Remission (HAMD17 ≤ 7) - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"0.54","spread":"0.22"},{"groupId":"OG001","value":"0.49","spread":"0.46"}]}]},{"title":"Remission (HAMD17 ≤ 10) - Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"0.54","spread":"0.19"},{"groupId":"OG001","value":"0.53","spread":"0.31"}]}]},{"title":"Remission (HAMD17 ≤ 10) - Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"0.70","spread":"0.21"},{"groupId":"OG001","value":"0.72","spread":"0.47"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.706","pValueComment":"p-values for Week 13 remission (HAMD17 ≤ 7).","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.694","pValueComment":"p-values for Week 25 Remission HAMD17 ≤ 7","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.864","pValueComment":"p-values for Week 13 Remission - HAMD17 ≤ 10","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.817","pValueComment":"p-values for Week 25 Remission - HAMD17 ≤ 10","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)analysis model:Remission = Treatment + Pooled Investigator + Visit + Baseline + Treatment\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Probability of Response at Endpoint as Measured by ≥50% Improvement in the HAMD-17 Total Score","description":"Response (visitwise binary outcome, yes/no) is defined as ≥ 50% reduction from baseline in the HAMD-17 total score. HAMD-17 measures depression severity. The total score can range from 0 (normal) to 52 (severe depression). The visitwise probability of patients meeting criteria for response was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. This analysis included the fixed, categorical effects of treatment, investigator, visit, and treatment-by-visit interaction, as well as the continuous, fixed covariate of baseline score.","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"probability of response","timeFrame":"Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"95"}]}],"classes":[{"title":"Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"0.44","spread":"0.19"},{"groupId":"OG001","value":"0.48","spread":"0.29"}]}]},{"title":"Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"0.61","spread":"0.20"},{"groupId":"OG001","value":"0.72","spread":"0.46"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.664","pValueComment":"p-value is for probability of response at Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.310","pValueComment":"p-value is for probability of response at Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)analysis model:Response = Treatment + Pooled Investigator + Visit + Baseline + Treatment\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Probability of Remission as Measured by the HAMD-17 Total Score ≤7 and ≤10 by Medical Comorbidity Severity as Assessed by the Cumulative Illness Rating Scale-Geriatric Version (CIRS-G)","description":"Remission defined as HAMD-17 Total Score ≤7 and ≤10. HAMD-17 measures depression severity. Total score ranges: 0 (normal) to 52 (severe depression). Visitwise probability of patients achieving remission was analyzed using a categorical, pseudo-likelihood-based repeated measures approach. CIRS-G evaluates 14 organ-specific categories using a rating strategy of 0=no problems; 1=current mild problem/past significant problem; 2=moderate disability/morbidity; 3=severe/constant significant disability; and 4=extremely severe/immediate treatment required/end organ failure. Total score ranges: 0 to 56.","populationDescription":"Randomized patients with non-missing data at baseline and post-baseline visit.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"probability of remission","timeFrame":"Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"95"}]}],"classes":[{"title":"Remission HAMD-17 ≤ 7 Week 13 (CIRS-G ≥ 6)","categories":[{"measurements":[{"groupId":"OG000","value":"0.44","spread":"0.07"},{"groupId":"OG001","value":"0.44","spread":"0.10"}]}]},{"title":"Remission HAMD-17 ≤ 7 Week 13 (CIRS-G < 6)","categories":[{"measurements":[{"groupId":"OG000","value":"0.33","spread":"0.07"},{"groupId":"OG001","value":"0.20","spread":"0.10"}]}]},{"title":"Remission HAMD-17 ≤ 10 Week 13 (CIRS-G ≥ 6)","categories":[{"measurements":[{"groupId":"OG000","value":"0.53","spread":"0.07"},{"groupId":"OG001","value":"0.52","spread":"0.10"}]}]},{"title":"Remission HAMD-17 ≤ 10 Week 13 (CIRS-G <6)","categories":[{"measurements":[{"groupId":"OG000","value":"0.53","spread":"0.07"},{"groupId":"OG001","value":"0.57","spread":"0.14"}]}]},{"title":"Remission HAMD-17 ≤ 7 Week 25 (CIRS-G ≥ 6)","categories":[{"measurements":[{"groupId":"OG000","value":"0.52","spread":"0.08"},{"groupId":"OG001","value":"0.42","spread":"0.13"}]}]},{"title":"Remission HAMD-17 ≤ 7 Week 25 (CIRS-G <6)","categories":[{"measurements":[{"groupId":"OG000","value":"0.53","spread":"0.08"},{"groupId":"OG001","value":"0.45","spread":"0.25"}]}]},{"title":"Remission HAMD-17 ≤ 10 Week 25 (CIRS-G ≥ 6)","categories":[{"measurements":[{"groupId":"OG000","value":"0.71","spread":"0.06"},{"groupId":"OG001","value":"0.65","spread":"0.12"}]}]},{"title":"Remission HAMD-17 ≤ 10 Week 25 (CIRS-G <6)","categories":[{"measurements":[{"groupId":"OG000","value":"0.63","spread":"0.08"},{"groupId":"OG001","value":"0.72","spread":"0.25"}]}]}]},{"type":"SECONDARY","title":"Probability of Efficacy Onset as Measured by at Least 20% Sustained Reduction From Baseline in the HAMD-17 Maier Subscale at Week 3","description":"Patients are considered to have met onset (visitwise binary outcome, yes/no) criteria at a particular visit if they had at least 20% reduction from baseline in the HAMD-17 Maier subscale at that visit and at all subsequent visits in the acute phase. Maier subscale measures core symptoms of depression and scores range from 0 (normal) to 24 (severe). The visitwise probability of patients meeting onset criteria was analyzed using a categorical, pseudo-likelihood-based repeated measures approach.","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"Probability of onset","timeFrame":"Week 3","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"201"},{"groupId":"OG001","value":"95"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.43","spread":"0.04"},{"groupId":"OG001","value":"0.30","spread":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.036","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM)analysis model: Onset = Treatment + Visit + Baseline + Treatment\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Supine Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)","populationDescription":"All randomized patients with a baseline and at least one non-missing post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"mmHg","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"118"}]}],"classes":[{"title":"Systolic BP Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"0.19","spread":"0.94"},{"groupId":"OG001","value":"-0.58","spread":"1.39"}]}]},{"title":"Diastolic BP Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"1.89","spread":"0.62"},{"groupId":"OG001","value":"-1.58","spread":"0.92"}]}]},{"title":"Systolic BP Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"2.22","spread":"1.09"},{"groupId":"OG001","value":"0.54","spread":"1.99"}]}]},{"title":"Diastolic BP Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"2.44","spread":"0.68"},{"groupId":"OG001","value":"0.65","spread":"1.23"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.637","pValueComment":"p-value is for Systolic BP change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","pValueComment":"p-value is for Diastolic BP change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.452","pValueComment":"p-value is for Systolic BP change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.193","pValueComment":"p-value is for Diastolic BP change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Pulse Rate","populationDescription":"All randomized patients with a baseline and at least one non-missing post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"beats per minute (bpm)","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"118"}]}],"classes":[{"title":"Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"0.03","spread":"0.60"},{"groupId":"OG001","value":"-1.56","spread":"0.88"}]}]},{"title":"Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"2.10","spread":"0.69"},{"groupId":"OG001","value":"-0.87","spread":"1.28"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.121","pValueComment":"p-value is for change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.038","pValueComment":"p-value is for change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Weight","populationDescription":"All randomized patients with a baseline and at least one non-missing post-baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"kilograms (kg)","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"121"}]}],"classes":[{"title":"Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.86","spread":"0.17"},{"groupId":"OG001","value":"0.06","spread":"0.26"}]}]},{"title":"Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.69","spread":"0.22"},{"groupId":"OG001","value":"-0.03","spread":"0.38"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","pValueComment":"p-value is for Weight change from baseline (Week 1) to Week 13.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.127","pValueComment":"p-value is for Weight change from baseline (Week 1) to Week 25.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Mixed Model Repeated Measures (MMRM) analysis model: Change = Treatment + Pooled Investigator + Visit + Treatment\\* Visit + Baseline + Baseline\\*Visit.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Number of Participants With Abnormal Vital Signs and Weight at Any Time During the Study","description":"A patient has a treatment-emergent elevated supine systolic blood pressure if the value is ≥140 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine diastolic blood pressure if the value is ≥90 with an increase ≥10 from baseline. A patient has a treatment-emergent elevated supine pulse if the value is ≥100 with an increase ≥10 from baseline.\n\nA patient has abnormal weight change if the gain or loss is ≥7% compared to baseline.","populationDescription":"All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"Baseline (Week 1) through Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"248"},{"groupId":"OG001","value":"121"}]}],"classes":[{"title":"Diastolic Blood Pressure - High (n=210, n=98)","categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"5"}]}]},{"title":"Pulse - High (n=243, n=115)","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"4"}]}]},{"title":"Systolic Blood Pressure - High (n=119, n=58)","categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"7"}]}]},{"title":"Weight Change (gain)","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"2"}]}]},{"title":"Weight Change (loss)","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.135","pValueComment":"p-value is for Diastolic Blood Pressure.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Pulse","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"1.00","pValueComment":"p-value is for Pulse.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.107","pValueComment":"p-value is for Systolic Blood Pressure","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.235","pValueComment":"p-value is for Weight Change (gain)","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.813","pValueComment":"p-value is for Weight Change (loss)","statisticalMethod":"Fisher Exact","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Number of Participants Experiencing Sustained Hypertension (SH) or Orthostatic Hypotension (OH)","description":"Sustained Hypertension is defined as supine systolic BP \\>= 140 (or diastolic BP \\>= 90) mm Hg and increase from baseline (highest value in baseline visit interval) \\>= 10 mm Hg for 3 or more consecutive visits in postbaseline visit interval. Orthostatic Hypotension is defined as standing diastolic BP at least 10 mm Hg less than the supine diastolic BP or the standing systolic BP at least 20 mm Hg less than the supine systolic BP at any time in postbaseline visit interval and a patient does not meet this criterion at any visit in baseline interval.","populationDescription":"All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Participants","timeFrame":"baseline (Week 1) through Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"118"}]}],"classes":[{"title":"Sustained Hypertension","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"1"}]}]},{"title":"Orthostatic Hypotension (n=183, n=90)","categories":[{"measurements":[{"groupId":"OG000","value":"57"},{"groupId":"OG001","value":"21"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.668","pValueComment":"p-value is for Sustained Hypertension","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.201","pValueComment":"p-value is for Orthostatic Hypotension","statisticalMethod":"Fisher Exact","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation","description":"Adverse Events and Serious Adverse Events leading to study discontinuation.","populationDescription":"All randomized patients.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"baseline (Week 1) through Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo Non-rescue","description":"Participants who were randomized to placebo at baseline and for whom treatment rescue was not required during continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they continued to receive placebo until completing or discontinuing from the study."},{"id":"OG002","title":"Placebo Rescue","description":"Participants who were randomized to placebo at baseline and for whom rescue treatment was required during the continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally until completing or discontinuing from the study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"249"},{"groupId":"OG001","value":"86"},{"groupId":"OG002","value":"35"}]}],"classes":[{"title":"Total Discontinued due to Adverse Events","categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"0"}]}]},{"title":"Diarrhoea","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Fatigue","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Headache","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"}]}]},{"title":"Nausea","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Constipation","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Dizziness","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Hypertension","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Memory 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fracture","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Insomnia","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Intracranial aneurysm","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Lethargy","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Oesophageal adenocarcinoma metastatic","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Palpitations","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Paranasal sinus hypersecretion","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Pneumoperitoneum","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Presyncope","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Rash pruritic","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Renal failure acute","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Suicidal ideation","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Tremor","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline in Laboratory Values - Platelet Count","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","populationDescription":"All randomized patients with a baseline and at least one post-baseline value in each treatment group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"billions per liter (bill/L)","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"227"},{"groupId":"OG001","value":"108"}]}],"classes":[{"title":"Platelet Count Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"7.92","spread":"45.75"},{"groupId":"OG001","value":"-4.66","spread":"42.95"}]}]},{"title":"Platelet Count Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"10.58","spread":"51.66"},{"groupId":"OG001","value":"-6.11","spread":"39.87"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","pValueComment":"p-value is for Platelet Count change from baseline (Week 1) to Week 13.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"p-value is for Platelet Count change from baseline (Week 1) to Week 25.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Laboratory Values - Uric Acid","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","populationDescription":"All randomized patients with a baseline and at least one post-baseline value in each treatment group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"micromole/liter","timeFrame":"baseline (Week 1), Week 13, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"112"}]}],"classes":[{"title":"Week 13 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-11.63","spread":"63.05"},{"groupId":"OG001","value":"9.30","spread":"47.39"}]}]},{"title":"Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-9.93","spread":"59.64"},{"groupId":"OG001","value":"10.26","spread":"48.29"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"p-value is for Uric Acid change from baseline (Week 1) to Week 13.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change = Treatment + Pooled Investigator","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"p-value is for Uric Acid change from baseline (Week 1) to Week 25.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change = Treatment + Pooled Investigator","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Laboratory Values - Erythrocyte Count","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","populationDescription":"All randomized patients with a baseline and at least one post-baseline value in each treatment group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Trillion/Liter","timeFrame":"baseline (Week 1), Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"109"}]}],"classes":[{"title":"Erythrocyte Count","categories":[{"measurements":[{"groupId":"OG000","value":"-0.04","spread":"0.29"},{"groupId":"OG001","value":"0.01","spread":"0.25"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.014","pValueComment":"p-value is for Erythrocyte Count change from baseline (Week 1) to Week 25.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Laboratory Values - Hemoglobin, Mean Cell Hemoglobin Concentration (MCHC)","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","populationDescription":"All randomized patients with a baseline and at least one post-baseline value in each treatment group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Micromole/liter (Fe)","timeFrame":"baseline (Week 1), Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"228"},{"groupId":"OG001","value":"109"}]}],"classes":[{"title":"Hemoglobin Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.11","spread":"0.56"},{"groupId":"OG001","value":"0.01","spread":"0.46"}]}]},{"title":"Mean Cell Hemoglobin Concentration Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.20","spread":"0.81"},{"groupId":"OG001","value":"-0.02","spread":"0.81"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.019","pValueComment":"p-value is for Hemoglobin change from baseline (Week 1) to Week 25.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change = Treatment + Pooled Investigator","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.048","pValueComment":"p-value is for Mean Cell Hemoglobin Concentration change from baseline (Week 1) to Week 25.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Laboratory Values - Chloride and Fasting Glucose","description":"Results are reported for laboratory analytes that exhibited statistically significantly different changes from baseline to endpoint between treatment groups. Statistical significance was considered at the 0.05 level.","populationDescription":"All randomized patients with a baseline and at least one post-baseline value in each treatment group.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimole/liter","timeFrame":"baseline (Week 1), Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"230"},{"groupId":"OG001","value":"112"}]}],"classes":[{"title":"Chloride Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.63","spread":"2.83"},{"groupId":"OG001","value":"0.01","spread":"2.77"}]}]},{"title":"Fasting Glucose Week 25 Change (n=155, n=67)","categories":[{"measurements":[{"groupId":"OG000","value":"0.37","spread":"1.88"},{"groupId":"OG001","value":"-0.11","spread":"1.06"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.040","pValueComment":"p-value is for Chloride change from baseline (Week 1) to Week 25.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change = Treatment + Pooled Investigator","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.036","pValueComment":"p-value is for Fasting Glucose change from baseline (Week 1) to Week 25.","statisticalMethod":"ANOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Number of Participants With Abnormal Laboratory Values - Low Leukocyte Count","description":"The number of participants with abnormal laboratory values at any time during the study period. Results are reported for laboratory analytes that exhibited statistically significantly different proportions of participants who had abnormal values between treatment groups. Statistical significance was considered at the 0.05 level. The lower limit of normal for leukocyte count is 3.8 Billion/Liter. Participants who had a value below that number were considered to have abnormally low leukocyte count.","populationDescription":"All randomized patients with a normal baseline and at least one post-baseline value in each treatment group.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"baseline (Week 1) through Week 13","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"225"},{"groupId":"OG001","value":"109"}]}],"classes":[{"title":"Leukocyte Count (Low)","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"0"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.019","statisticalMethod":"Fisher Exact","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline in Electrocardiograms","description":"The Electrocardiogram measures include the following time intervals: QT interval, QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF), QT Interval Corrected for Heart Rate Using Bazett's Formula (QTcB), PR interval and QRS interval.","populationDescription":"Participants with a baseline and at least one non-missing post baseline value.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millisecond (msec)","timeFrame":"baseline (Week 1), Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"194"},{"groupId":"OG001","value":"68"}]}],"classes":[{"title":"QT Interval Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-11.80","spread":"2.19"},{"groupId":"OG001","value":"-10.95","spread":"3.43"}]}]},{"title":"QTcF Interval Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-5.02","spread":"1.48"},{"groupId":"OG001","value":"-5.91","spread":"2.33"}]}]},{"title":"QTcB Interval Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.38","spread":"1.61"},{"groupId":"OG001","value":"-3.78","spread":"2.55"}]}]},{"title":"PR Interval Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-5.91","spread":"1.45"},{"groupId":"OG001","value":"-1.34","spread":"2.32"}]}]},{"title":"QRS Interval Week 25 Change","categories":[{"measurements":[{"groupId":"OG000","value":"-1.11","spread":"0.80"},{"groupId":"OG001","value":"-3.25","spread":"1.26"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.815","pValueComment":"p-value is for QT Interval change from baseline (Week 1) to Week 25.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator+Baseline","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.721","pValueComment":"p-value is for QTcF Interval change from baseline (Week 1) to Week 25.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator+Baseline","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.376","pValueComment":"p-value is for QTcB Interval change from baseline (Week 1) to Week 25.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator+Baseline","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.065","pValueComment":"p-value is for PR Interval change from baseline (Week 1) to Week 25.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator+Baseline","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.110","pValueComment":"p-value is for QRS Interval change from baseline (Week 1) to Week 25.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator+Baseline","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Number of Participants With Successful Treatment Outcome","description":"Successful treatment outcome defined as: Participant completed the study and being in remission (HAMD-17 Total score ≤7 and ≤10) at least for the last two visits (4 weeks)of the study. The HAMD-17 is used to assess the severity of depression. The total score ranges from 0 (not at all depressed) to 52 (severely depressed).","populationDescription":"All participants randomized under protocol amendment c,d,e, and that have non-missing successful treatment values.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Baseline (Week 1) through Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"204"},{"groupId":"OG001","value":"95"}]}],"classes":[{"title":"Successful Treatment Outcome (with HAMD17 ≤ 7)","categories":[{"measurements":[{"groupId":"OG000","value":"55"},{"groupId":"OG001","value":"17"}]}]},{"title":"Successful Treatment Outcome (with HAMD17 ≤ 10)","categories":[{"measurements":[{"groupId":"OG000","value":"74"},{"groupId":"OG001","value":"21"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.110","pValueComment":"p-value is for Successful Treatment Outcome defined with HAMD-17 ≤7 criteria.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.016","pValueComment":"p-value is for Successful Treatment Outcome defined with HAMD-17 ≤10 criteria.","statisticalMethod":"Fisher Exact","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Change From Baseline on Cognitive Test Scores: Verbal Learning and Recall Test (VLRT), Symbol Digit Substitution Test (SDST), Trail Making Test (Part B), 2-Digit Cancellation Test (2DCT), and the Composite Cognitive Score Derived From the Above Scores","description":"The cognitive assessment battery is composed of four tests: Verbal Learning (score 0-15)and Delayed Recall(score 0-15) test, SDST(Score 0-133),2DCT(score 0-40),Trail Making(Part B)(score 0-180).They are designed to challenge the patient's abilities in the following areas: verbal learning and memory; attention to visually presented material; and working memory and executive function. Composite Cognitive score(0-51)is derived from normalized individual test scores. For Trail Making Test,lower number indicates better cognition. For all other test scores,higher number indicates better cognition.","populationDescription":"All participants randomized under protocol amendment c,d,e, and have a baseline observation and at least one post-randomization observation.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline (Week 1), Week 9, Week 25","groups":[{"id":"OG000","title":"Duloxetine","description":"Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity."},{"id":"OG001","title":"Placebo","description":"Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"183"},{"groupId":"OG001","value":"90"}]}],"classes":[{"title":"Composite Cognitive Score Week 9","categories":[{"measurements":[{"groupId":"OG000","value":"-0.38","spread":"0.38"},{"groupId":"OG001","value":"0.01","spread":"0.51"}]}]},{"title":"Composite Cognitive Score Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"0.96","spread":"0.40"},{"groupId":"OG001","value":"0.31","spread":"0.54"}]}]},{"title":"Learning Trials Score Week 9","categories":[{"measurements":[{"groupId":"OG000","value":"-0.06","spread":"0.12"},{"groupId":"OG001","value":"-0.04","spread":"0.17"}]}]},{"title":"Learning Trials Score Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"0.34","spread":"0.13"},{"groupId":"OG001","value":"0.06","spread":"0.18"}]}]},{"title":"Delayed Recall Score Week 9","categories":[{"measurements":[{"groupId":"OG000","value":"-0.65","spread":"0.21"},{"groupId":"OG001","value":"-0.59","spread":"0.28"}]}]},{"title":"Delayed Recall Score Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"0.12","spread":"0.22"},{"groupId":"OG001","value":"-0.36","spread":"0.29"}]}]},{"title":"SDST Score Week 9","categories":[{"measurements":[{"groupId":"OG000","value":"1.98","spread":"0.76"},{"groupId":"OG001","value":"3.99","spread":"1.04"}]}]},{"title":"SDST Score Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"5.60","spread":"0.84"},{"groupId":"OG001","value":"3.61","spread":"1.15"}]}]},{"title":"2DCT Score Week 9","categories":[{"measurements":[{"groupId":"OG000","value":"0.30","spread":"0.46"},{"groupId":"OG001","value":"0.94","spread":"0.63"}]}]},{"title":"2DCT Score Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"0.87","spread":"0.51"},{"groupId":"OG001","value":"1.01","spread":"0.70"}]}]},{"title":"Trail Making Test (Part B) Week 9","categories":[{"measurements":[{"groupId":"OG000","value":"-5.60","spread":"2.90"},{"groupId":"OG001","value":"-3.09","spread":"4.00"}]}]},{"title":"Trail Making Test (Part B) Week 25","categories":[{"measurements":[{"groupId":"OG000","value":"-1.59","spread":"2.82"},{"groupId":"OG001","value":"-6.86","spread":"3.86"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.511","pValueComment":"p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 9.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator+Baseline","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.300","pValueComment":"p-value is for Composite Cognitive Score change from baseline (Week 1) to Week 25.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change=Treatment+Pooled Investigator+Baseline","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.922","pValueComment":"p-value is for Learning Trials Score change from baseline (Week 1) to Week 9.","statisticalMethod":"ANCOVA","statisticalComment":"Model: Change=Treatment+Pooled 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