{"protocolSection":{"identificationModule":{"nctId":"NCT00946998","orgStudyIdInfo":{"id":"CLIN-008-09S"},"secondaryIdInfos":[{"id":"1I01CX000217-01","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1I01CX000217-01"},{"id":"1R01DK085512-01A1","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1R01DK085512-01A1"}],"organization":{"fullName":"VA Office of Research and Development","class":"FED"},"briefTitle":"Chronic Kidney Disease Antidepressant Sertraline Trial","officialTitle":"Randomized Trial of Sertraline Treatment of Depression in Chronic Kidney Disease","acronym":"CAST"},"statusModule":{"statusVerifiedDate":"2018-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-02-08","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2016-11-23","type":"ACTUAL"},"completionDateStruct":{"date":"2017-11","type":"ACTUAL"},"studyFirstSubmitDate":"2009-07-23","studyFirstSubmitQcDate":"2009-07-23","studyFirstPostDateStruct":{"date":"2009-07-27","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-01-12","resultsFirstSubmitQcDate":"2018-01-12","resultsFirstPostDateStruct":{"date":"2018-01-30","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-02-09","lastUpdatePostDateStruct":{"date":"2018-03-09","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"VA Office of Research and Development","class":"FED"},"collaborators":[{"name":"University of Texas Southwestern Medical Center","class":"OTHER"},{"name":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"This is a randomized double-blinded placebo-controlled trial to see if treatment with sertraline as compared with placebo tablets will improve depression symptoms in patients with chronic kidney disease who have not yet started dialysis or received a kidney transplant. The investigators will also investigate whether sertraline treatment will improve quality of life and whether it is safe to use in patients with kidney disease. The study subject will be randomly assigned to take either sertraline or a placebo tablet for 12 weeks.","detailedDescription":"This is a randomized double-blinded placebo-controlled trial of adults with predialysis stages 3-5 Chronic Kidney Disease and Major Depressive Episode. Subjects will be randomized in a double-blind fashion to placebo or sertraline (beginning at 50 mg/d and escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d) and followed for 12 weeks. The primary outcome is to investigate if treatment with sertraline, as compared with placebo, results in an improvement in depression symptom severity as measured by the Quick Inventory of Depressive Symptomatology Clinician Rated (QIDS-C-16) score. Secondary outcomes include whether sertraline, as compared with placebo, improves overall function and quality of life and whether it will result in more serious adverse events."},"conditionsModule":{"conditions":["Chronic Kidney Disease","Depression"],"keywords":["Chronic Kidney Disease","Depression","Antidepressants","randomized controlled trial","treatment","Sertraline"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":201,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Sertraline","type":"ACTIVE_COMPARATOR","description":"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode","interventionNames":["Drug: Sertraline"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"Sertraline","description":"Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d","armGroupLabels":["Sertraline"]},{"type":"DRUG","name":"placebo","description":"Placebo tablet will be identical and matched to sertraline tablet.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.","description":"The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.","timeFrame":"baseline to 12 weeks"}],"secondaryOutcomes":[{"measure":"Response to Treatment Defined as a Decline of 50% in the Baseline QIDS-C-16 Score and Remission of Depression Defined as a QIDS-C-16 Score of 5","description":"The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.","timeFrame":"baseline to 12 weeks"},{"measure":"Change From Baseline to Exit in Overall Function as Assessed by the Work and Social Adjustment Scale","description":"Each item is rated on a 0 to 8 Likert scale with 0 indicating no impairment and 8 indicating severe impairment and a total score range of 0 to 40.","timeFrame":"baseline to 12 weeks"},{"measure":"Change in Quality of Life From Baseline to Exit in the Kidney Disease Quality of Life -Short Form, Version 1.3, Patient-reported Overall Health.","description":"Raw scores from version 1.3 were transformed to a scale from 0 to 100, in which higher numbers signify more favorable quality of life.","timeFrame":"baseline to 12 weeks"},{"measure":"Serious Adverse Events During the 12 Week Study Duration.","description":"death, dialysis initiation, hospitalizations, or bleeding requiring transfusion","timeFrame":"during 12 week study duration"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female adults aged greater than 21 years.\n* Predialysis stages 3, 4 or 5 CKD.\n* Current Major Depressive Episode.\n* QID-C-16 score of 11.\n* Able to understand and sign informed consent.\n\nExclusion Criteria:\n\n* No healthcare power of attorney to sign informed consent.\n* Unwilling or unable to participate.\n* Kidney transplant recipient.\n* Initiated on maintenance dialysis\n* Significant hepatic dysfunction or liver enzyme abnormalities 3 times the upper limits of normal.\n* Terminal chronic obstructive pulmonary disease or cancer.\n* Recent history of active bleeding, such as gastrointestinal bleeding requiring hospitalization 3 months prior\n* Current use of class I anti-arrhythmic medications.\n* Use of pimozide, MAO inhibitors, reserpine, guanethidine, cimetidine or methyldopa; tri-cyclic anti-depressants, neuroleptics or anti-convulsants, excluding gabapentin\n* Use of other serotonergic drugs or supplements such as triptans, tramadol, linezolid, tryptophan, and St. John's Wort.\n* Ongoing use of anti-depressants\n* Past treatment failure on Sertraline\n* Initiation of psychotherapy for depression in the 3 months prior to study entry\n* Alcohol or substance abuse or dependence that requires acute detoxification at study entry\n* Present or past psychosis or Bipolar I or II disorder\n* Dementia or a Mini-Mental State Examination score of \\<23\n* Suicidal ideation\n* Pregnancy, lactation and women of childbearing potential not using adequate contraception","healthyVolunteers":false,"sex":"ALL","minimumAge":"21 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Susan S Hedayati, MD MHS","affiliation":"University of Texas Southwestern Medical Center","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX","city":"Dallas","state":"Texas","zip":"75216","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}},{"facility":"University of Texas Southwestern Medical Center at Dallas","city":"Dallas","state":"Texas","zip":"75390","country":"United States","geoPoint":{"lat":32.78306,"lon":-96.80667}}]},"referencesModule":{"references":[{"pmid":"23085503","type":"RESULT","citation":"Jain N, Trivedi MH, Rush AJ, Carmody T, Kurian B, Toto RD, Sarode R, Hedayati SS. Rationale and design of the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST). Contemp Clin Trials. 2013 Jan;34(1):136-44. doi: 10.1016/j.cct.2012.10.004. Epub 2012 Oct 22."},{"pmid":"29101402","type":"RESULT","citation":"Hedayati SS, Gregg LP, Carmody T, Jain N, Toups M, Rush AJ, Toto RD, Trivedi MH. Effect of Sertraline on Depressive Symptoms in Patients With Chronic Kidney Disease Without Dialysis Dependence: The CAST Randomized Clinical Trial. JAMA. 2017 Nov 21;318(19):1876-1890. doi: 10.1001/jama.2017.17131."},{"pmid":"35368605","type":"DERIVED","citation":"Gregg LP, Carmody T, Le D, Bharadwaj N, Trivedi MH, Hedayati SS. Depression and the Effect of Sertraline on Inflammatory Biomarkers in Patients with Nondialysis CKD. Kidney360. 2020 Apr 13;1(6):436-446. doi: 10.34067/KID.0000062020. eCollection 2020 Jun 25."},{"pmid":"31664940","type":"DERIVED","citation":"Jain N, Wan F, Kothari M, Adelodun A, Ware J, Sarode R, Hedayati SS. Association of platelet function with depression and its treatment with sertraline in patients with chronic kidney disease: analysis of a randomized trial. BMC Nephrol. 2019 Oct 29;20(1):395. doi: 10.1186/s12882-019-1576-7."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Sertraline","description":"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode\n\nSertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"},{"id":"FG001","title":"Placebo","description":"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode\n\nplacebo: Placebo tablet will be identical and matched to sertraline tablet."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"102"},{"groupId":"FG001","numSubjects":"99"}]},{"type":"Received Treatment as Randomized","achievements":[{"groupId":"FG000","numSubjects":"102"},{"groupId":"FG001","numSubjects":"99"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"97"},{"groupId":"FG001","numSubjects":"96"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Exited prior to first outcome assessment","reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sertraline","description":"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode\n\nSertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. Dosage will begin at 50 mg/d and will be escalated by 50 mg increments every 2 weeks to a maximum of 200 mg/d"},{"id":"BG001","title":"Placebo","description":"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode\n\nplacebo: Placebo tablet will be identical and matched to sertraline tablet."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"97"},{"groupId":"BG001","value":"96"},{"groupId":"BG002","value":"193"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57.7","spread":"14.5"},{"groupId":"BG001","value":"59.1","spread":"12.2"},{"groupId":"BG002","value":"58.4","spread":"13.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"23"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"52"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"74"},{"groupId":"BG001","value":"67"},{"groupId":"BG002","value":"141"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"35"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"76"},{"groupId":"BG001","value":"82"},{"groupId":"BG002","value":"158"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"56"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"111"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"40"},{"groupId":"BG002","value":"81"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"97"},{"groupId":"BG001","value":"96"},{"groupId":"BG002","value":"193"}]}]}]},{"title":"Chronic Kidney Disease Stage","description":"Chronic kidney disease stages were categorized as follows: stage 3, estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m\\^2; stage 4, eGFR of 15-29; and stage 5, eGFR\\<15, but not dialysis-dependent.","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"CKD Stage 3","measurements":[{"groupId":"BG000","value":"46"},{"groupId":"BG001","value":"44"},{"groupId":"BG002","value":"90"}]},{"title":"CKD Stage 4","measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"36"},{"groupId":"BG002","value":"70"}]},{"title":"CKD Stage 5","measurements":[{"groupId":"BG000","value":"17"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"33"}]}]}]},{"title":"Diabetes Mellitus","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"55"},{"groupId":"BG002","value":"113"}]}]}]},{"title":"Estimated glomerular filtration rate","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"mL/min/1.73 m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27.0","lowerLimit":"18.0","upperLimit":"35.0"},{"groupId":"BG001","value":"27.5","lowerLimit":"17.0","upperLimit":"38.5"},{"groupId":"BG002","value":"27.5","lowerLimit":"17.0","upperLimit":"37.0"}]}]}]},{"title":"16-item Quick Inventory of Depression Symptomatology Clinician-rated Score","description":"The 16-item Quick Inventory of Depression Symptomatology measures depressive symptom severity. The range of final score is 0-27, with higher scores indicating more severe depression. A score of 0-5 corresponds to normal affect, 6-10 to mild, 11-15 to moderate, 16-20 to severe, and 21 to very severe depression.","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"14.0","spread":"2.4"},{"groupId":"BG001","value":"14.1","spread":"2.4"},{"groupId":"BG002","value":"14.0","spread":"2.4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change From Baseline to Exit in Depression Symptom Severity as Measured by the QIDS-C-16 Score.","description":"The score range is 0 to 27; higher scores indicate more severe depression; a score of 0 to 5 corresponds to a normal affect; 6 to 10 to a mild affect; 11 to 15 to a moderate affect; 16 to 20 to a severe affect; and 21 or greater to very severe depression.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"units on a scale","timeFrame":"baseline to 12 weeks","groups":[{"id":"OG000","title":"Sertraline","description":"Patients with predialysis Chronic Kidney Disease stages 3-5 and with major depressive episode\n\nSertraline: Sertraline is a serotonin-selective reuptake inhibitor (SSRI) used to treat major depression. 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