{"protocolSection":{"identificationModule":{"nctId":"NCT00078286","orgStudyIdInfo":{"id":"Pro00010340"},"secondaryIdInfos":[{"id":"R01MH063211","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01MH063211"},{"id":"DATR A4-GPX"}],"organization":{"fullName":"Duke University","class":"OTHER"},"briefTitle":"Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure","officialTitle":"Safety and Efficacy of Sertraline for Depression CHF","acronym":"SADHART-CHF"},"statusModule":{"statusVerifiedDate":"2013-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2003-11"},"primaryCompletionDateStruct":{"date":"2008-03","type":"ACTUAL"},"completionDateStruct":{"date":"2008-09","type":"ACTUAL"},"studyFirstSubmitDate":"2004-02-20","studyFirstSubmitQcDate":"2004-02-23","studyFirstPostDateStruct":{"date":"2004-02-24","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-05-11","resultsFirstSubmitQcDate":"2013-01-23","resultsFirstPostDateStruct":{"date":"2013-02-27","type":"ESTIMATED"},"lastUpdateSubmitDate":"2013-01-23","lastUpdatePostDateStruct":{"date":"2013-02-27","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Duke University","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study will examine the effect of antidepressant medication on rates of death and disease in depressed people with chronic heart failure.","detailedDescription":"Comorbid depression in people with chronic medical illness is a serious public health concern. Depressive disorders lead to increased morbidity, mortality, and poorer outcomes in ischemic heart disease, a leading cause of chronic heart failure (CHF). Evidence suggests that a relationship exists between depression and CHF; studies that examine the way CHF is affected by depression treatments are needed.\n\nParticipants in this study will be randomly assigned to receive either sertraline or placebo for 12 weeks. Assessments will be made at Weeks 2, 4, 6, 8, 10, and 12. Participants who do not respond to their treatment will have their medication dose adjusted following assessment. Interviews and rating scales will be used to assess depressive symptoms, cognitive status, psychiatric comorbidity, daily and chronic stress, and social support. A follow-up visit will take place 6 months, 1 year, 2 years, and 3 years after study completion."},"conditionsModule":{"conditions":["Heart Failure, Congestive","Chronic Heart Failure","Depression"],"keywords":["Antidepressive Agents"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2","PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":469,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Sertraline","type":"EXPERIMENTAL","description":"Participants will take sertraline for 12 weeks","interventionNames":["Drug: Sertraline"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants will take placebo for 12 weeks","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Sertraline","description":"Dosage ranging from 50 mg to 200 mg once a day","armGroupLabels":["Sertraline"],"otherNames":["Zoloft"]},{"type":"DRUG","name":"Placebo","description":"Dosage ranging from 50 mg to 200 mg once a day","armGroupLabels":["Placebo"],"otherNames":["Inactive pill"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo","description":"Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.\n\nThe 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period.","timeFrame":"Measured at Week 12"}],"secondaryOutcomes":[{"measure":"Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.","description":"Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.","timeFrame":"Measured at Week 12"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Chronic heart failure\n* Diagnostic and Statistical Manual- Fourth Edition (DSM-IV) criteria for major depression\n* Current use of any antipsychotic medication at study entry\n\nExclusion Criteria:\n\n* Life-threatening comorbidity with a 50% or higher likelihood of death within 1 year\n* History of psychoses, bipolar disorder, or severe personality disorder\n* History of alcohol or drug dependence in the last year\n* Severe physical disability that may interfere with the study\n* Neurological impairment\n* Active suicidal ideations\n* Current use of antidepressant medication(s) at the start of study medication","healthyVolunteers":false,"sex":"ALL","minimumAge":"45 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ranga Krishnan, PhD","affiliation":"Duke University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Duke Medical Center","city":"Durham","state":"North Carolina","zip":"27710","country":"United States","geoPoint":{"lat":35.99403,"lon":-78.89862}}]},"referencesModule":{"references":[{"pmid":"20723799","type":"RESULT","citation":"O'Connor CM, Jiang W, Kuchibhatla M, Silva SG, Cuffe MS, Callwood DD, Zakhary B, Stough WG, Arias RM, Rivelli SK, Krishnan R; SADHART-CHF Investigators. Safety and efficacy of sertraline for depression in patients with heart failure: results of the SADHART-CHF (Sertraline Against Depression and Heart Disease in Chronic Heart Failure) trial. J Am Coll Cardiol. 2010 Aug 24;56(9):692-9. doi: 10.1016/j.jacc.2010.03.068."},{"pmid":"26186432","type":"DERIVED","citation":"Xiong GL, Prybol K, Boyle SH, Hall R, Streilein RD, Steffens DC, Krishnan R, Rogers JG, O'Connor CM, Jiang W; SADHART-CHF Investigators. Inflammation Markers and Major Depressive Disorder in Patients With Chronic Heart Failure: Results From the Sertraline Against Depression and Heart Disease in Chronic Heart Failure Study. Psychosom Med. 2015 Sep;77(7):808-15. doi: 10.1097/PSY.0000000000000216."},{"pmid":"20101071","type":"DERIVED","citation":"Steffens DC, Wei Jiang, Krishnan KR, Karoly ED, Mitchell MW, O'Connor CM, Kaddurah-Daouk R. Metabolomic differences in heart failure patients with and without major depression. J Geriatr Psychiatry Neurol. 2010 Jun;23(2):138-46. doi: 10.1177/0891988709358592. Epub 2010 Jan 25."},{"pmid":"18760123","type":"DERIVED","citation":"Jiang W, O'Connor C, Silva SG, Kuchibhatla M, Cuffe MS, Callwood DD, Zakhary B, Henke E, Arias RM, Krishnan R; SADHART-CHF Investigators. Safety and efficacy of sertraline for depression in patients with CHF (SADHART-CHF): a randomized, double-blind, placebo-controlled trial of sertraline for major depression with congestive heart failure. Am Heart J. 2008 Sep;156(3):437-44. doi: 10.1016/j.ahj.2008.05.003. Epub 2008 Jul 7."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Recruitment began in November, 2003 and concluded in March, 2008. Subjects were recruited from cardiology inpatient units as well as outpatient cardiology clinics.","groups":[{"id":"FG000","title":"Sertraline","description":"Participants will take sertraline for 12 weeks"},{"id":"FG001","title":"Placebo","description":"Participants will take placebo for 12 weeks"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"234"},{"groupId":"FG001","numSubjects":"235"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"138"},{"groupId":"FG001","numSubjects":"152"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"83"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sertraline","description":"Participants will take sertraline for 12 weeks"},{"id":"BG001","title":"Placebo","description":"Participants will take placebo for 12 weeks"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"234"},{"groupId":"BG001","value":"235"},{"groupId":"BG002","value":"469"}]}],"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":"0.0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"131"},{"groupId":"BG001","value":"147"},{"groupId":"BG002","value":"278.0"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"103"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"191.0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"62.9","spread":"10.5"},{"groupId":"BG001","value":"61.4","spread":"11.1"},{"groupId":"BG002","value":"62.1","spread":"10.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"101"},{"groupId":"BG001","value":"89"},{"groupId":"BG002","value":"190.0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"133"},{"groupId":"BG001","value":"146"},{"groupId":"BG002","value":"279.0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Symptoms of Depression in Congestive Heart Failure Patients With Clinical Depression After Treatment With Sertraline or Placebo","description":"Symptoms of depression (as measured by the Hamilton Depression Rating Scale, HDRS) in congestive heart failure patients with clinical depression after treatment with sertraline or placebo.\n\nThe 17-item Hamilton Depression Rating Scale (HDRS) is a rater-administered assessment of depression severity, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed). Change in depression was measured as the difference between the 12-week HDRS scores and the baseline HDRS scores. Thus, a negative value reflects an improvement in depressive symptoms over the 12-week period.","populationDescription":"Analysis was based on intent to treat (ITT), using random coefficient modeling.","reportingStatus":"POSTED","anticipatedPostingDate":"2009-03","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"HDRS Change Score","timeFrame":"Measured at Week 12","groups":[{"id":"OG000","title":"Sertraline","description":"Participants will take sertraline for 12 weeks"},{"id":"OG001","title":"Placebo","description":"Participants will take placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"234"},{"groupId":"OG001","value":"235"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.1","spread":"0.5"},{"groupId":"OG001","value":"-6.8","spread":"0.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"A hierarchical mixed model was used, analyzing the fixed effects of treatment, the natural log of time, natural log of time squared, the interactions of time and time squared with treatment and site, as well as the random effects of patient, patient-by-time, and square of patient-by-time.","testedNonInferiority":true,"nonInferiorityType":"NON_INFERIORITY_OR_EQUIVALENCE","nonInferiorityComment":"\\*Power analysis already provided.","pValue":"0.89","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Significance was tested at p=.05.","paramType":"Difference in mean change score","paramValue":"-0.3","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Percentage of Cardiac Events and Morbidity / Mortality, Including Rehospitalization, in Congestive Heart Failure Patients With Depression After Treatment With Sertraline or Placebo.","description":"Composite cardiovascular scores are calculated for each participant using recorded cardiac events, morbidity/mortality, rehospitalization, and discontinuation due to cardiovascular events. Composite score is compared for sertraline and placebo treatment groups.","populationDescription":"Analysis was based on intent to treat (ITT).","reportingStatus":"POSTED","anticipatedPostingDate":"2009-03","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Measured at Week 12","groups":[{"id":"OG000","title":"Sertraline","description":"Participants will take sertraline for 12 weeks"},{"id":"OG001","title":"Placebo","description":"Participants will take placebo for 12 weeks"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"138"},{"groupId":"OG001","value":"152"}]}],"classes":[{"title":"Cardiovascular Status Worsened","categories":[{"measurements":[{"groupId":"OG000","value":"29.9"},{"groupId":"OG001","value":"31.1"}]}]},{"title":"Cardiovascular Status Improved","categories":[{"measurements":[{"groupId":"OG000","value":"40.6"},{"groupId":"OG001","value":"43.8"}]}]},{"title":"Cardiovascular Status Unchanged","categories":[{"measurements":[{"groupId":"OG000","value":"29.5"},{"groupId":"OG001","value":"25.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Tests for differences of proportions were used to examine the composite cardiovascular status outcome at the end of acute treatment. Chi-square tests were used to test for overall treatment differences, with a Mantel Haenszel test performed to examine treatment differences when controlling for clinical site. The primary analyses were conducted on the tri-level cardiovascular status outcome.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".78","statisticalMethod":"Cochran-Mantel-Haenszel","paramType":"Odds Ratio (OR)","paramValue":"0.08","ciPctValue":"95"}]}]},"adverseEventsModule":{"frequencyThreshold":"0.80","timeFrame":"12-weeks","description":"All participants were followed via phone or mail to ascertain clinical events and vital status every 2 weeks during the 12-week treatment phase. The national death index was used to ascertain vital status of participants who could not be reached via phone or mail.","eventGroups":[{"id":"EG000","title":"Sertraline","description":"Serious adverse events in Sertraline Arm","seriousNumAffected":57,"seriousNumAtRisk":234,"otherNumAffected":22,"otherNumAtRisk":234},{"id":"EG001","title":"Placebo","description":"Serious adverse events in Placebo Arm","seriousNumAffected":63,"seriousNumAtRisk":235,"otherNumAffected":23,"otherNumAtRisk":235}],"seriousEvents":[{"term":"Cardiovascular","organSystem":"Cardiac disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":69,"numAffected":40,"numAtRisk":234},{"groupId":"EG001","numEvents":72,"numAffected":44,"numAtRisk":235}]},{"term":"Psychiatric","organSystem":"Psychiatric disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":234},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":235}]},{"term":"Noncardiovascular and nonpsychiatric","organSystem":"General disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":29,"numAffected":17,"numAtRisk":234},{"groupId":"EG001","numEvents":22,"numAffected":17,"numAtRisk":235}]}],"otherEvents":[{"term":"Congestive Heart Failure","organSystem":"Cardiac disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":19,"numAffected":11,"numAtRisk":234},{"groupId":"EG001","numEvents":20,"numAffected":10,"numAtRisk":235}]},{"term":"Unstable Angina","organSystem":"Cardiac disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":2,"numAtRisk":234},{"groupId":"EG001","numEvents":5,"numAffected":2,"numAtRisk":235}]},{"term":"Other Cardiovascular","organSystem":"Cardiac disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":12,"numAffected":9,"numAtRisk":234},{"groupId":"EG001","numEvents":16,"numAffected":11,"numAtRisk":235}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"NFS may have limited our ability to detect effect of sertraline on depression scores. Dropout rate was higher than expected. A 12-week duration of therapy may have been insufficient to show potential effects of sertraline on clinical outcomes."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Ranga Krishnan","organization":"Duke University","email":"krish001@mc.duke.edu","phone":"919-668-3647"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D006333","term":"Heart Failure"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D006331","term":"Heart Diseases"},{"id":"D002318","term":"Cardiovascular Diseases"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D020280","term":"Sertraline"}],"ancestors":[{"id":"D015057","term":"1-Naphthylamine"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009281","term":"Naphthalenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}