{"protocolSection":{"identificationModule":{"nctId":"NCT03548454","orgStudyIdInfo":{"id":"44758"},"organization":{"fullName":"Stanford University","class":"OTHER"},"briefTitle":"Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization","officialTitle":"Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization"},"statusModule":{"statusVerifiedDate":"2025-10","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2018-09-20","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-12-24","type":"ACTUAL"},"completionDateStruct":{"date":"2024-06-26","type":"ACTUAL"},"studyFirstSubmitDate":"2018-04-17","studyFirstSubmitQcDate":"2018-05-24","studyFirstPostDateStruct":{"date":"2018-06-07","type":"ACTUAL"},"resultsFirstSubmitDate":"2025-08-29","resultsFirstSubmitQcDate":"2025-10-22","resultsFirstPostDateStruct":{"date":"2025-11-06","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-10-22","lastUpdatePostDateStruct":{"date":"2025-11-06","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Vafi Salmasi","investigatorTitle":"Clinical Instructor","investigatorAffiliation":"Stanford University"},"leadSponsor":{"name":"Stanford University","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. Our work aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in our department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). Collaborative Health Outcomes Information Registry uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of duloxetine and desipramine in decreasing pain in patients with chronic pain. The investigators will also compare adherence of patients to these two commonly used medications over a period of six months. This will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in subspecialty clinics. Collaborative Health Outcomes Information Registry can then be applied for numerous future trials to advance our knowledge in perioperative and pain medicine."},"conditionsModule":{"conditions":["Chronic Pain"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"HEALTH_SERVICES_RESEARCH","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":86,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","description":"Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated.","interventionNames":["Drug: Duloxetine"]},{"label":"Desipramine","type":"EXPERIMENTAL","description":"Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated.","interventionNames":["Drug: Desipramine"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"Open label prescription","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta"]},{"type":"DRUG","name":"Desipramine","description":"Open label prescription","armGroupLabels":["Desipramine"],"otherNames":["Norpramin"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Pain Intensity","description":"Percent of participants in each arm that had more than 30% reduction in pain intensity. Participants rated their pain on an 11-point scale (0 to 10; 0 = no pain, 10 = worst pain imaginable).","timeFrame":"baseline and 6 months"}],"secondaryOutcomes":[{"measure":"Physical Function","description":"National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to better function.","timeFrame":"Baseline and 6 months"},{"measure":"Pain Interference","description":"National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to worse pain interference.","timeFrame":"Baseline and 6 months"},{"measure":"Depression","description":"National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to more severe depression.","timeFrame":"Baseline and 6 months"},{"measure":"Anxiety","description":"National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for anxiety. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to more severe anxiety.","timeFrame":"Baseline and 6 months"},{"measure":"Adherence","description":"Number of participants who completed 6-month therapy based on prescription records.","timeFrame":"Monthly for 6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion criteria:\n\n1. Age of 18 years old or above\n2. Persistent pain for more than 3 months\n3. Candidate for treatment by anti-depressant based on treating pain provider\n\nExclusion criteria:\n\n1. Prior failure of duloxetine and/or desipramine (patients who have failed other TCAs or SNRIs can be considered for the trial based on the reason for previous medication failure)\n2. Contraindication to taking duloxetine or desipramine\n3. Patient refusal","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Vafi Salmasi, MD.","affiliation":"Stanford University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Stanford Pain Management Center","city":"Redwood City","state":"California","zip":"94063","country":"United States","geoPoint":{"lat":37.48522,"lon":-122.23635}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Patients were equally randomized to duloxetine and desipramine (43 in each arm); however, five patients chose not to take desipramine and crossed over to the duloxetine group before starting study medication.","groups":[{"id":"FG000","title":"Desipramine","description":"Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated."},{"id":"FG001","title":"Duloxetine","description":"Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"48"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"48"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Desipramine","description":"Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated."},{"id":"BG001","title":"Duloxetine","description":"Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"86"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"47.78","spread":"14.36"},{"groupId":"BG001","value":"47.25","spread":"16.67"},{"groupId":"BG002","value":"47.48","spread":"15.62"}]}]}]},{"title":"Sex: Female, Male","populationDescription":"Participants with non-missing data","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"47"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"39"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"15"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"31"},{"groupId":"BG002","value":"60"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"11"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"American Indian or Alaska Native","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]},{"title":"Asian","categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"9"}]}]},{"title":"Black or African American","categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]},{"title":"Unknown/Refused","categories":[{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"11"}]}]},{"title":"White","categories":[{"measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"44"}]}]},{"title":"Other","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"20"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"86"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Pain Intensity","description":"Percent of participants in each arm that had more than 30% reduction in pain intensity. Participants rated their pain on an 11-point scale (0 to 10; 0 = no pain, 10 = worst pain imaginable).","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"baseline and 6 months","groups":[{"id":"OG000","title":"Desipramine","description":"Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"48"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"29"}]}]}]},{"type":"SECONDARY","title":"Physical Function","description":"National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for physical function. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to better function.","populationDescription":"Participants with data at the respective time point","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"T-score","timeFrame":"Baseline and 6 months","groups":[{"id":"OG000","title":"Desipramine","description":"Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"48"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"39.29","spread":"7.63"},{"groupId":"OG001","value":"39.07","spread":"6.33"}]}]},{"title":"6-month","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"41.9","spread":"8.91"},{"groupId":"OG001","value":"39.39","spread":"6.98"}]}]},{"title":"Change from baseline at 6-month","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"2.54","spread":"5.83"},{"groupId":"OG001","value":"1.36","spread":"3.88"}]}]}]},{"type":"SECONDARY","title":"Pain Interference","description":"National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for pain interference. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to worse pain interference.","populationDescription":"Participants with data at the respective time point","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"T-score","timeFrame":"Baseline and 6 months","groups":[{"id":"OG000","title":"Desipramine","description":"Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine starting at 20 mg per day and increasing to 60 mg per day as tolerated."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"48"}]}],"classes":[{"title":"Baseline","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"48"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"64.37","spread":"7.1"},{"groupId":"OG001","value":"64.93","spread":"6.48"}]}]},{"title":"6-month","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"60.82","spread":"7.1"},{"groupId":"OG001","value":"62.11","spread":"6.98"}]}]},{"title":"Change from baseline at 6-month","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-4.29","spread":"7.57"},{"groupId":"OG001","value":"-4.06","spread":"7.51"}]}]}]},{"type":"SECONDARY","title":"Depression","description":"National Institute of Health Patient Reported Outcomes Measurement Information System Standardized score for depression. Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. 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Raw scores were converted to T-scores with a population mean of 50 with standard deviation of 10. Overall score range: 0 to 100, higher scores correspond to more severe anxiety.","populationDescription":"Participants with data at the respective time point","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"T-score","timeFrame":"Baseline and 6 months","groups":[{"id":"OG000","title":"Desipramine","description":"Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine starting at 20 mg per day and increasing to 60 mg per day as 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6-month","denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"45"}]}],"categories":[{"measurements":[{"groupId":"OG000","value":"-1.2","spread":"7.11"},{"groupId":"OG001","value":"-1.29","spread":"11.89"}]}]}]},{"type":"SECONDARY","title":"Adherence","description":"Number of participants who completed 6-month therapy based on prescription records.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"Monthly for 6 months","groups":[{"id":"OG000","title":"Desipramine","description":"Desipramine starting at 25 mg per day and increasing to 75 mg per day as tolerated."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine starting at 20 mg per day and increasing to 60 mg per day as 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tolerated.","deathsNumAffected":0,"deathsNumAtRisk":48,"seriousNumAffected":0,"seriousNumAtRisk":48,"otherNumAffected":4,"otherNumAtRisk":48}],"otherEvents":[{"term":"Did not tolerate","organSystem":"Investigations","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Patient mentioned they did not tolerate the medication and refused to provide more information why","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Drowsiness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Daytime drowsiness","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Coagulopathy","organSystem":"Blood and lymphatic system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"prolonged bleeding and easier bruising","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Urinary frequency","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"urinary frequency and urgency","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Urinary retention","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":38},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":48}]},{"term":"Insomnia","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":48}]},{"term":"Increased pain","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":48}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":48}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":38},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":48}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Vafi Salmasi","organization":"Stanford University","email":"vsalmasi@stanford.edu","phone":"650-725-0246"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2022-05-17","uploadDate":"2025-10-22T19:31","filename":"Prot_001.pdf","size":330853},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis Plan: Original Statistical Analysis Plan","date":"2018-04-24","uploadDate":"2025-10-22T19:34","filename":"SAP_002.pdf","size":94492},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical 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