{"protocolSection":{"identificationModule":{"nctId":"NCT00360724","orgStudyIdInfo":{"id":"# 4967/6363R"},"organization":{"fullName":"New York State Psychiatric Institute","class":"OTHER"},"briefTitle":"Duloxetine for Chronic Depression: a Double-blind Study","officialTitle":"Duloxetine for Chronic Depression: a Double-blind Study"},"statusModule":{"statusVerifiedDate":"2017-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-08"},"primaryCompletionDateStruct":{"date":"2011-12","type":"ACTUAL"},"completionDateStruct":{"date":"2013-12","type":"ACTUAL"},"studyFirstSubmitDate":"2006-08-03","studyFirstSubmitQcDate":"2006-08-03","studyFirstPostDateStruct":{"date":"2006-08-07","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-10-01","resultsFirstSubmitQcDate":"2015-10-05","resultsFirstPostDateStruct":{"date":"2015-11-03","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-07-20","lastUpdatePostDateStruct":{"date":"2017-08-21","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"New York State Psychiatric Institute","class":"OTHER"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia).\n\nChronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication.\n\nEligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.","detailedDescription":"This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. Participants can have Dysthymic Disorder (Dysthymia), or Depression, Not Otherwise Specified (Depression NOS).\n\nThe first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12 weeks (Continuation Phase) is open-label and all subjects will receive active medication.\n\nTests of cytokine functioning will be performed and analyzed for treatment and placebo effects.\n\nIn addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI) sub-study, in which a variety of brain imaging techniques (including anatomical MRI, functional MRI (fMRI), MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at baseline and week 10. Duloxetine responders will have a third MRI performed at week 22."},"conditionsModule":{"conditions":["Dysthymic Disorder","Depressive Disorder NOS"],"keywords":["dysthymia","dysthymic disorder","chronic depression","chronic low-grade depression","atypical depression","minor depression","depression NOS","depression","depressive disorder","mood disorder","unipolar depression","low-grade depression"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":65,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"duloxetine (cymbalta)","type":"EXPERIMENTAL","description":"Duloxetine medication: a medication currently marketed in the USA that is reported to have pharmacological effects including reuptake blockage for serotonin and norepinephrine","interventionNames":["Drug: Duloxetine (Cymbalta)"]},{"label":"Placebo treatment","type":"PLACEBO_COMPARATOR","description":"placebo treatment: treatment with placebo capsules that match active medication capsules","interventionNames":["Drug: Duloxetine (Cymbalta)"]}],"interventions":[{"type":"DRUG","name":"Duloxetine (Cymbalta)","description":"duloxetine medication up to dose of 120 mg/day","armGroupLabels":["Placebo treatment","duloxetine (cymbalta)"],"otherNames":["duloxetine","Cymbalta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton Depression Rating Scale (HDRS) - 24 Total Score","description":"HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression","timeFrame":"Week 10"},{"measure":"Hamilton Depression Rating Scale (HDRS) - 24 Total Score","description":"HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression","timeFrame":"Baseline"}],"secondaryOutcomes":[{"measure":"Cornell Dysthymia Rating Scale (CDRS)","description":"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).\n\nScores from 0 to 82 with higher score indicating worse depression","timeFrame":"Week 10"},{"measure":"Global Assessment of Functioning Scale (GAF)","description":"A commonly used rating scale for global social function.\n\nRange from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).\n\n61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others\n\n1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.\n\n0 Inadequate information","timeFrame":"Week 10"},{"measure":"Beck Depression Inventory (BDI)","description":"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.\n\nWhen the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:\\[7\\]\n\n0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.\n\nHigher total scores indicate more severe depressive symptoms.","timeFrame":"Week 10"},{"measure":"Clinical Global Impressions Improvement(CGI-I)","description":"The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline.\n\n0 = Not assessed\n\n1. = Very much improved\n2. = Much improved\n3. = Minimally improved\n4. = No change\n5. = Minimally worse\n6. = Much worse\n7. = Very much worse Higher score=greatest worsening","timeFrame":"10 weeks"},{"measure":"Cornell Dysthymia Rating Scale (CDRS)","description":"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).\n\nScores from 0 to 82 with higher score indicating worse depression","timeFrame":"Baseline"},{"measure":"Beck Depression Inventory (BDI)","description":"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.\n\nWhen the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:\\[7\\]\n\n0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.\n\nHigher total scores indicate more severe depressive symptoms.","timeFrame":"Baseline"},{"measure":"Global Assessment of Functioning Scale (GAF)","description":"A commonly used rating scale for global social function.\n\nRange from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).\n\n61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others\n\n1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.\n\n0 Inadequate information","timeFrame":"Baseline"}],"otherOutcomes":[{"measure":"Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)","description":"To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.","timeFrame":"Baseline"},{"measure":"Resting-state Functional Connectivity Magnetic Resonance Imaging(fMRI)","description":"To use resting-state fMRI to study the effects of antidepressant therapy on default mode network (DMN) connectivity density.","timeFrame":"Follow up"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* age 20 to 75 years (ages 20 to 60 for MRI sub-study)\n* diagnosis of dysthymic disorder (chronic depression) or depression NOS\n* minimum of 2 years duration of current episode of depression\n\nExclusion Criteria:\n\n* current major depression\n* diagnoses including delirium, dementia, bipolar disorder, schizophrenia\n* substance abuse or dependence in the past 6 months\n* pregnant or nursing women\n* serious risk of suicide","healthyVolunteers":false,"sex":"ALL","minimumAge":"20 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"David J. Hellerstein, MD","affiliation":"New York State Psychiatric Institute","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"New York State Psychiatric Institute","city":"New York","state":"New York","zip":"10032","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]},"referencesModule":{"references":[{"pmid":"22901348","type":"RESULT","citation":"Hellerstein DJ, Stewart JW, McGrath PJ, Deliyannides DA, Batchelder ST, Black SR, Withers A, O'Shea D, Chen Y. A randomized controlled trial of duloxetine versus placebo in the treatment of nonmajor chronic depression. J Clin Psychiatry. 2012 Jul;73(7):984-91. doi: 10.4088/JCP.11m07230."},{"pmid":"42214294","type":"DERIVED","citation":"Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. Effects of antidepressant medications on brain tissue microstructure in persistent depressive disorder across two randomized controlled trials. Neuroimage Clin. 2026;50:104013. doi: 10.1016/j.nicl.2026.104013. Epub 2026 May 27."},{"pmid":"35592490","type":"DERIVED","citation":"Yang J, Hellerstein DJ, Chen Y, McGrath PJ, Stewart JW, Peterson BS, Wang Z. Serotonin-norepinephrine reuptake inhibitor antidepressant effects on regional connectivity of the thalamus in persistent depressive disorder: evidence from two randomized, double-blind, placebo-controlled clinical trials. Brain Commun. 2022 Apr 15;4(3):fcac100. doi: 10.1093/braincomms/fcac100. eCollection 2022."},{"pmid":"31323045","type":"DERIVED","citation":"Bansal R, Hellerstein DJ, Sawardekar S, O'Neill J, Peterson BS. Effects of the antidepressant medication duloxetine on brain metabolites in persistent depressive disorder: A randomized, controlled trial. PLoS One. 2019 Jul 19;14(7):e0219679. doi: 10.1371/journal.pone.0219679. eCollection 2019."},{"pmid":"28064115","type":"DERIVED","citation":"Hellerstein DJ, Hunnicutt-Ferguson K, Stewart JW, McGrath PJ, Keller S, Peterson BS, Chen Y. Do social functioning and symptoms improve with continuation antidepressant treatment of persistent depressive disorder? An observational study. J Affect Disord. 2017 Mar 1;210:258-264. doi: 10.1016/j.jad.2016.12.026. Epub 2016 Dec 20."}],"seeAlsoLinks":[{"label":"Mood Disorders Research Program website","url":"http://www.DepressionNY.com"},{"label":"Columbia University Department of Psychiatry website","url":"http://asp.cumc.columbia.edu/facdb/psychiatry/"}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"For patients on current ineffective psychotropic medication, washout was required, with \\>=7 days medication-free (\\>=28 days for fluoxetine). Concurrent sleep medication (zolpidem) was allowed for a maximum of 5 days during the study.","recruitmentDetails":"Subjects were recruited by advertisements, website postings, and from the hospital's telephone referral service. Conducted between August 2006 and December 2011. Potential participants provided informed consent for study participation. A physical examination was performed and blood and urine samples were collected, including urine toxicology.","groups":[{"id":"FG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"FG001","title":"Placebo Treatment","description":"placebo treatment, treatment with matching capsules of placebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"32"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"29"},{"groupId":"FG001","numSubjects":"28"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"BG001","title":"Placebo Treatment","description":"placebo treatment: treatment with placebo capsules that match active medication capsules"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"65"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"32"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"64"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"41","spread":"11.7"},{"groupId":"BG001","value":"42.1","spread":"11.4"},{"groupId":"BG002","value":"41.6","spread":"11.2"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"28"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"37"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"32"},{"groupId":"BG002","value":"65"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton Depression Rating Scale (HDRS) - 24 Total Score","description":"HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression","populationDescription":"Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Week 10","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment, with capsules matching the duloxetine medication"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"5","spread":"3.6"},{"groupId":"OG001","value":"10","spread":"5.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Repeated measures ANOVA was used to compare measures between baseline and week 10.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".003","statisticalMethod":"Repeated Measures ANOVA","statisticalComment":"df 1,55","paramType":"F statistics","paramValue":"9.43","estimateComment":"time X Drug group, f=9.43,df 1,55, p=.003"}]},{"type":"PRIMARY","title":"Hamilton Depression Rating Scale (HDRS) - 24 Total Score","description":"HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression","populationDescription":"Patients for whom post-baseline data was available and scored 2 or less on the suicide item either at baseline or during the course of treatment.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment, with capsules matching the duloxetine medication"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"14.1","spread":"3.8"},{"groupId":"OG001","value":"14.9","spread":"3.5"}]}]}]},{"type":"SECONDARY","title":"Cornell Dysthymia Rating Scale (CDRS)","description":"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).\n\nScores from 0 to 82 with higher score indicating worse depression","populationDescription":"subjects for whom data post baseline were available","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"scores on a scale","timeFrame":"Week 10","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment: treatment with placebo capsules that match active medication capsules"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"19.1","spread":"9.5"},{"groupId":"OG001","value":"28.5","spread":"14.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Repeated measures ANOVA was used to compare measures between baseline and week 10.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.05","statisticalMethod":"Repeated Measures ANOVA","statisticalComment":"d.f. 1,55","paramType":"F statistics","paramValue":"8.72","estimateComment":"Time x Treatment: F=8.72, d.f=1,55, p=0.05"}]},{"type":"SECONDARY","title":"Global Assessment of Functioning Scale (GAF)","description":"A commonly used rating scale for global social function.\n\nRange from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).\n\n61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others\n\n1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.\n\n0 Inadequate information","populationDescription":"subjects for whom post-baseline data were available","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"points on rating scale","timeFrame":"Week 10","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment: treatment with placebo capsules that match active medication capsules"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"69.9","spread":"20.9"},{"groupId":"OG001","value":"65.7","spread":"14"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Repeated measures ANOVA was used to compare measures between baseline and week 10.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.025","statisticalMethod":"Repeated measures ANOVA","statisticalComment":"d.f. 1,55","paramType":"F statistics","paramValue":"5.33"}]},{"type":"SECONDARY","title":"Beck Depression Inventory (BDI)","description":"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.\n\nWhen the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:\\[7\\]\n\n0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.\n\nHigher total scores indicate more severe depressive symptoms.","populationDescription":"subjects fro whom post-baseline data was available","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Week 10","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment: treatment with placebo capsules that match active medication capsules"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8.5","spread":"7"},{"groupId":"OG001","value":"10.1","spread":"6.2"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Repeated measures ANOVA was used to compare measures between baseline and week 10.","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6","statisticalMethod":"Repeated measures ANOVA","statisticalComment":"d.f.=1,55","paramType":"F statistics","paramValue":"0.26"}]},{"type":"SECONDARY","title":"Clinical Global Impressions Improvement(CGI-I)","description":"The Clinical Global Impression - Improvement(CGI-I) is a 7-point scale that rate patient's total improvement whether or not comparing to his/her condition at baseline.\n\n0 = Not assessed\n\n1. = Very much improved\n2. = Much improved\n3. = Minimally improved\n4. = No change\n5. = Minimally worse\n6. = Much worse\n7. = Very much worse Higher score=greatest worsening","populationDescription":"subjects for whom post-baseline data was available","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"10 weeks","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment: treatment with placebo capsules that match active medication capsules"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.4","spread":".8"},{"groupId":"OG001","value":"3","spread":"1.1"}]}]}]},{"type":"SECONDARY","title":"Cornell Dysthymia Rating Scale (CDRS)","description":"CDRS is a 20-item clinician-rated inventory for chronic depressive symptoms. Each item was characterized by an explanatory or illustrative description and rated from 0 (symptom absent) to 4 (severe symptoms).\n\nScores from 0 to 82 with higher score indicating worse depression","populationDescription":"subjects for whom data post baseline were available","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment: treatment with placebo capsules that match active medication capsules"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"36.9","spread":"8.0"},{"groupId":"OG001","value":"37.4","spread":"8.0"}]}]}]},{"type":"SECONDARY","title":"Beck Depression Inventory (BDI)","description":"Beck Depression Inventory (BDI)is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression.\n\nWhen the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:\\[7\\]\n\n0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.\n\nHigher total scores indicate more severe depressive symptoms.","populationDescription":"subjects for whom post-baseline data was available","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Scores on a scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment: treatment with placebo capsules that match active medication capsules"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"28"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.7","spread":"5.8"},{"groupId":"OG001","value":"15.5","spread":"5.5"}]}]}]},{"type":"SECONDARY","title":"Global Assessment of Functioning Scale (GAF)","description":"A commonly used rating scale for global social function.\n\nRange from 0 to 100; higher score=better functioning. 91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 no more than slight impairment in social, occupational, or school functioning (e.g., temporarily falling behind in schoolwork).\n\n61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Some impairment in reality testing or communication 21 - 30 Behavior is considerably influenced by delusions or hallucinations or serious impairment, in communication or judgment 11 - 20 Some danger of hurting self or others\n\n1 - 10 Persistent danger of severely hurting self or others or persistent inability to maintain minimal personal hygiene or serious suicidal act with clear expectation of death.\n\n0 Inadequate information","populationDescription":"subjects for whom post-baseline data were available","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"points on rating scale","timeFrame":"Baseline","groups":[{"id":"OG000","title":"Duloxetine (Cymbalta)","description":"Duloxetine medication, ranging from 30 to 120 mg/day"},{"id":"OG001","title":"Placebo Treatment","description":"placebo treatment: treatment with placebo capsules that match active medication 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