{"protocolSection":{"identificationModule":{"nctId":"NCT01035073","orgStudyIdInfo":{"id":"F1J-US-X018"},"organization":{"fullName":"University of Pennsylvania","class":"OTHER"},"briefTitle":"Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome","officialTitle":"Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms"},"statusModule":{"statusVerifiedDate":"2020-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-04"},"primaryCompletionDateStruct":{"date":"2009-05","type":"ACTUAL"},"completionDateStruct":{"date":"2009-05","type":"ACTUAL"},"studyFirstSubmitDate":"2009-12-17","studyFirstSubmitQcDate":"2009-12-17","studyFirstPostDateStruct":{"date":"2009-12-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-04-03","resultsFirstSubmitQcDate":"2020-04-03","resultsFirstPostDateStruct":{"date":"2020-04-16","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-04-03","lastUpdatePostDateStruct":{"date":"2020-04-16","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of Pennsylvania","class":"OTHER"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures.\n\nWe hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed."},"conditionsModule":{"conditions":["Major Depressive Disorder","Soft Tissue Discomfort Syndrome","Pain"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":22,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","interventionNames":["Drug: Duloxetine"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"30-60 mg daily for 8 weeks","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"24-hour Activity Level","timeFrame":"Baseline and Week One of Treatment"}],"secondaryOutcomes":[{"measure":"Functional Symptom Questionnaire","timeFrame":"Baseline; Week 6 and Week 8 of Treatment"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* \\> 17 years old\n* All races and ethnicity\n* DSM IV-TR Axis I diagnosis of MDD\n* Co-morbid STDS\n* Baseline 17-item Hamilton Depression Rating \\> 13\n\nExclusion Criteria:\n\n* Primary Axis I disorder other than MDD\n* History of mania or psychosis\n* Actively suicidal\n* Required hospitalization\n* A alcohol or substance abuse or dependence within the preceding 3 months\n* Pregnant or nursing\n* Unstable medical condition (other than STDS)\n* Narrow-angle glaucoma\n* Sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use\n* Hepatic or renal insufficiency","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jay D Amsterdam, MD","affiliation":"University of Pennsylvania","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Depression Research Unit, University of Pennsylvania School of Medicine","city":"Philadelphia","state":"Pennsylvania","zip":"19104-3309","country":"United States","geoPoint":{"lat":39.95238,"lon":-75.16362}}]},"referencesModule":{"seeAlsoLinks":[{"label":"Depression Research Unit","url":"http://www.med.upenn.edu/dru"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.","groups":[{"id":"FG000","title":"Duloxetine","description":"Duloxetine: 30-60 mg daily for 8 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"0"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.","groups":[{"id":"BG000","title":"Duloxetine","description":"Duloxetine: 30-60 mg daily for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"}]}],"measures":[{"title":"Age, Customized","unitOfMeasure":"participants","classes":[{"title":"All Participants"}]},{"title":"Sex/Gender, Customized","unitOfMeasure":"participants","classes":[{"title":"All Participants"}]},{"title":"Race and Ethnicity Not Collected","populationDescription":"Race and Ethnicity were not collected from any participant."},{"title":"Region of Enrollment","unitOfMeasure":"participants","classes":[{"title":"United States"}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"24-hour Activity Level","populationDescription":"The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.","reportingStatus":"POSTED","timeFrame":"Baseline and Week One of Treatment","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine: 30-60 mg daily for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Functional Symptom Questionnaire","populationDescription":"The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.","reportingStatus":"POSTED","timeFrame":"Baseline; Week 6 and Week 8 of Treatment","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine: 30-60 mg daily for 8 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"3 Years","description":"The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.","eventGroups":[{"id":"EG000","title":"Duloxetine","description":"Duloxetine: 30-60 mg daily for 8 weeks","deathsNumAffected":0,"deathsNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":0}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Data is unavailable for the following reasons:\n\ninvestigator has succumb to serious health conditions preventing him from entering data, and study team members no longer work for the university and cannot be reached to input data despite efforts."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Tyrone Quarterman","organization":"University of Pennsylvania","email":"tyroneq@upenn.edu","phone":"215-349-5537"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D010146","term":"Pain"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D009461","term":"Neurologic Manifestations"},{"id":"D012816","term":"Signs and Symptoms"},{"id":"D013568","term":"Pathological Conditions, Signs and Symptoms"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068736","term":"Duloxetine Hydrochloride"}],"ancestors":[{"id":"D013876","term":"Thiophenes"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}