{"protocolSection":{"identificationModule":{"nctId":"NCT00105989","orgStudyIdInfo":{"id":"8606"},"secondaryIdInfos":[{"id":"F1J-MC-HMDI"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder","officialTitle":"Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder"},"statusModule":{"statusVerifiedDate":"2009-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-03"},"primaryCompletionDateStruct":{"date":"2008-01","type":"ACTUAL"},"completionDateStruct":{"date":"2008-01","type":"ACTUAL"},"studyFirstSubmitDate":"2005-03-18","studyFirstSubmitQcDate":"2005-03-18","studyFirstPostDateStruct":{"date":"2005-03-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-01-23","resultsFirstSubmitQcDate":"2009-06-05","resultsFirstPostDateStruct":{"date":"2009-07-17","type":"ESTIMATED"},"lastUpdateSubmitDate":"2009-07-21","lastUpdatePostDateStruct":{"date":"2009-07-28","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"}]},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder."},"conditionsModule":{"conditions":["Depressive Disorder, Major"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":514,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"A","type":"EXPERIMENTAL","description":"duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks","interventionNames":["Drug: Duloxetine"]},{"label":"B","type":"PLACEBO_COMPARATOR","description":"duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","armGroupLabels":["A"],"otherNames":["LY248686","Cymbalta"]},{"type":"DRUG","name":"placebo","armGroupLabels":["B"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Participants With Depressive Recurrence After Time (t) in Days","description":"Recurrence: Clinical Global Impression-Severity (CGI-S) score \\>=4 and met Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder (MDD); had 3 consecutive visits where re-emergence criteria met; had total of 10 visits where re-emergence criteria was satisfied; discontinued due to lack of efficacy.","timeFrame":"Every Visit from Week 34 up to Week 86 (Maintenance Phase)"}],"secondaryOutcomes":[{"measure":"Recurrence Count","description":"Number of participants who experienced a depressive recurrence at any time during the double-blind maintenance therapy phase.","timeFrame":"Every Visit from Week 35 up to Week 86 (Maintenance Phase)"},{"measure":"Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days","description":"Worsening occurs if patient had a \\>=50% increase from baseline on the 17-Item Hamilton Depression Rating Scale (HAMD-17) total score and a Clinical Global Impression-Severity (CGI-S) score \\>=3 at any time during the double-blind maintenance therapy phase.","timeFrame":"Every Visit from Week 34 up to Week 86 (Maintenance Phase)"},{"measure":"Loss of Response at Any Time","description":"Loss of response was defined as a HAMD-17 total score \\>9 and a CGI-Severity score \\>2 at any one time during the double-blind maintenance phase of the study regardless of whether or not they subsequently regained response or not.","timeFrame":"Every Visit from Week 35 up to Week 86 (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases","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).","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase","description":"The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases","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":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase","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":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases","description":"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).","timeFrame":"Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase","description":"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).","timeFrame":"Week 86 (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases","description":"Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. 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). Depressed Mood Item (0-4).","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase","description":"Core and Maier subscales assess symptoms of depression (scores:0-20=Core; 0-24=Maier). Higher numbers indicate more severe symptoms. 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). Depressed Mood item (0-4).","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase","description":"VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase","description":"VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases","description":"The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase","description":"The Somatic subscale consists of 23 items to be completed by the patient that focus on somatic symptoms. Question answers are either yes/no or true/false. Negative response is scored at 1; positive response is scored as 0. Total Somatic subscale scores range from 0-23, where higher scores indicate greater symptom severity.","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases","description":"The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase","description":"The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total (Global) scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Individual Item scores range from 0 to 10.","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase","description":"Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase","description":"Assesses general quality of life. 36 questions covering 8 health domains. Each subscale is scored by summing the individual items and transforming scores into a 0-100 scale, with higher scores indicating better health status or functioning.","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases","description":"Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.","timeFrame":"Week 0 through Week10 (Acute) through Week 34 (Continuation)"},{"measure":"Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase","description":"Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.","timeFrame":"Week 34 through Week 86 (Maintenance Phase)"},{"measure":"Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases","description":"Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase","description":"Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase","description":"Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase","description":"Measures direct and indirect costs. Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Patients self-report on number of days over the past month that they have been either late to work, missed work, or missed usual activities due to symptoms.","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)","description":"A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)","description":"A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)","description":"A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)","description":"A 5-item patient-rated scale measuring 5 domains: sexual drive, arousal (subjective excitement), lubrication/erection (physiological excitement), ability to reach orgasm, orgasm satisfaction. Higher score means worse dysfunction. Total score range is 5-30.","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases","timeFrame":"Week 0 and Week 10 (Acute) and Week 34 (Continuation)"},{"measure":"Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase","timeFrame":"Week 0 and Week 10"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase","timeFrame":"Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase","timeFrame":"Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)"},{"measure":"Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase","timeFrame":"Every Visit from Week 0 up to Week 10 (Acute)"},{"measure":"Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase","timeFrame":"Every Visit from Week 10 up to Week 34 (Continuation)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patient must be at least 18 years old.\n* Patient must be diagnosed with depression and have had previous episodes of depression.\n* Patient must sign informed consent.\n\nExclusion Criteria:\n\n* Female and pregnant or breastfeeding.\n* History of bipolar disorder, schizophrenia, or other psychotic disorders.\n* Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.\n* Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.\n* Have taken an antidepressant called fluoxetine within 30 days of the start of the study.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Newport Beach","state":"California","country":"United States","geoPoint":{"lat":33.61891,"lon":-117.92895}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Sherman Oaks","state":"California","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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Baltimore","state":"Maryland","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Gaithersburg","state":"Maryland","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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Brooklyn","state":"New York","country":"United States","geoPoint":{"lat":40.6501,"lon":-73.94958}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Angoulême","country":"France","geoPoint":{"lat":45.64997,"lon":0.15345}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Douai","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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Fains","country":"France","geoPoint":{"lat":48.99793,"lon":1.38789}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"La Rochelle","country":"France","geoPoint":{"lat":46.16308,"lon":-1.15222}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Lille","country":"France","geoPoint":{"lat":50.63391,"lon":3.05512}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Nîmes","country":"France","geoPoint":{"lat":43.83665,"lon":4.35788}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Roubaix","country":"France","geoPoint":{"lat":50.69421,"lon":3.17456}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Strasbourg","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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Berlin","country":"Germany","geoPoint":{"lat":52.52437,"lon":13.41053}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ellwangen","country":"Germany","geoPoint":{"lat":48.96164,"lon":10.13173}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hamburg","country":"Germany","geoPoint":{"lat":53.55073,"lon":9.99302}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hildesheim","country":"Germany","geoPoint":{"lat":52.15077,"lon":9.95112}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Leipzig","country":"Germany","geoPoint":{"lat":51.33962,"lon":12.37129}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"München","country":"Germany","geoPoint":{"lat":51.60698,"lon":13.31243}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Würzburg","country":"Germany","geoPoint":{"lat":49.79391,"lon":9.95121}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Catania","country":"Italy","geoPoint":{"lat":37.49223,"lon":15.07041}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Ferrara","country":"Italy","geoPoint":{"lat":44.83804,"lon":11.62057}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 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5 hours, EST), or speak with your personal physician.","city":"Sundsvall","country":"Sweden","geoPoint":{"lat":62.39129,"lon":17.3063}}]},"referencesModule":{"references":[{"pmid":"19552867","type":"DERIVED","citation":"Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. doi: 10.4088/jcp.08m04756."}],"seeAlsoLinks":[{"label":"Lilly Clinical Trial Registry","url":"http://www.lillytrials.com"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The Acute - Open Label (Week 0-10) participants were reported in the Baseline Characteristics section of this results record.","groups":[{"id":"FG000","title":"Duloxetine","description":"duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks."},{"id":"FG001","title":"Placebo","description":"duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks."}],"periods":[{"title":"Acute - Open Label: Week 0-10","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"514"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"413"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"101"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lack of Efficacy","reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Protocol Response Criteria Not Met","reasons":[{"groupId":"FG000","numSubjects":"14"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Recurrence Criteria Met","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Unspecified - 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