{"protocolSection":{"identificationModule":{"nctId":"NCT00964886","orgStudyIdInfo":{"id":"NURA-019-09S"},"organization":{"fullName":"VA Office of Research and Development","class":"FED"},"briefTitle":"Efficacy of Antidepressants in Chronic Back Pain","officialTitle":"Efficacy of Antidepressants in Chronic Back Pain"},"statusModule":{"statusVerifiedDate":"2016-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-01"},"primaryCompletionDateStruct":{"date":"2014-12","type":"ACTUAL"},"completionDateStruct":{"date":"2015-12","type":"ACTUAL"},"studyFirstSubmitDate":"2009-08-24","studyFirstSubmitQcDate":"2009-08-24","studyFirstPostDateStruct":{"date":"2009-08-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-11-23","resultsFirstSubmitQcDate":"2016-11-23","resultsFirstPostDateStruct":{"date":"2016-11-29","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-11-23","lastUpdatePostDateStruct":{"date":"2016-11-29","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"VA Office of Research and Development","class":"FED"},"collaborators":[{"name":"University of California, San Diego","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.","detailedDescription":"This is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (\\< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine mesylate)."},"conditionsModule":{"conditions":["Back Pain"],"keywords":["chronic pain","back pain","antidepressants"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":142,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Arm 1","type":"EXPERIMENTAL","description":"desipramine hydrochloride","interventionNames":["Drug: desipramine hydrochloride"]},{"label":"Arm 2","type":"EXPERIMENTAL","description":"cognitive behavioral therapy","interventionNames":["Behavioral: cognitive behavioral therapy"]},{"label":"Arm 3","type":"EXPERIMENTAL","description":"desipramine hydrochloride and cognitive behavioral therapy","interventionNames":["Drug: desipramine hydrochloride","Behavioral: cognitive behavioral therapy"]},{"label":"Arm 4","type":"PLACEBO_COMPARATOR","description":"anticholinergic medication; active placebo","interventionNames":["Drug: benztropine mesylate 0.125 mg daily"]}],"interventions":[{"type":"BEHAVIORAL","name":"cognitive behavioral therapy","description":"cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life","armGroupLabels":["Arm 2"]},{"type":"DRUG","name":"desipramine hydrochloride","description":"desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml","armGroupLabels":["Arm 3"],"otherNames":["Anafranil"]},{"type":"BEHAVIORAL","name":"cognitive behavioral therapy","description":"cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life","armGroupLabels":["Arm 3"]},{"type":"DRUG","name":"benztropine mesylate 0.125 mg daily","description":"benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride","armGroupLabels":["Arm 4"],"otherNames":["Cogentin"]},{"type":"DRUG","name":"desipramine hydrochloride","description":"desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml","armGroupLabels":["Arm 1"],"otherNames":["Anafranil"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Intent-toTreat Analysis of Descriptor Differential Scale (DDS) of Pain Intensity","description":"The DDS is self-report measure of \"current\" pain intensity of chronic back pain. 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The analysis evaluated the 'as randomized' sample at 12 weeks after baseline, after co-varying for baseline (pre-treatment) values.","timeFrame":"12 weeks after baseline (or last observation carried forward)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Chronic back pain (daily pain for \\> 6 months)\n\nExclusion Criteria:\n\n* Major medical conditions which might contraindicate antidepressant treatment","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"70 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Joseph H Atkinson, MD","affiliation":"VA San Diego Healthcare System, San Diego, CA","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"VA San Diego Healthcare System, San Diego, CA","city":"San Diego","state":"California","zip":"92161","country":"United States","geoPoint":{"lat":32.71571,"lon":-117.16472}}]},"referencesModule":{"references":[{"pmid":"32068667","type":"DERIVED","citation":"Gould HM, Atkinson JH, Chircop-Rollick T, D'Andrea J, Garfin S, Patel SM, Funk SD, Capparelli EV, Penzien DB, Wallace M, Weickgenanta AL, Slater M, Rutledge T. A randomized placebo-controlled trial of desipramine, cognitive behavioral therapy, and active placebo therapy for low back pain. Pain. 2020 Jun;161(6):1341-1349. doi: 10.1097/j.pain.0000000000001834."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"Available in SPSS format from the investigators."}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Arm 1","description":"desipramine hydrochloride\n\ndesipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"},{"id":"FG001","title":"Arm 2","description":"cognitive behavioral therapy\n\ncognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"},{"id":"FG002","title":"Arm 3","description":"desipramine hydrochloride and cognitive behavioral therapy\n\ndesipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml\n\ncognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy 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