{"protocolSection":{"identificationModule":{"nctId":"NCT02901249","orgStudyIdInfo":{"id":"017/2009"},"organization":{"fullName":"Federal University of Rio Grande do Sul","class":"OTHER"},"briefTitle":"Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder","officialTitle":"Assessment of Cost- Effectiveness Interventions and the Quality of Life in Patients With Major Depression Through Resources Available in Brazilian Public Health"},"statusModule":{"statusVerifiedDate":"2016-08","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-05"},"primaryCompletionDateStruct":{"date":"2014-11","type":"ACTUAL"},"completionDateStruct":{"date":"2015-09","type":"ACTUAL"},"studyFirstSubmitDate":"2016-09-11","studyFirstSubmitQcDate":"2016-09-11","studyFirstPostDateStruct":{"date":"2016-09-15","type":"ESTIMATED"},"resultsFirstSubmitDate":"2020-08-15","resultsFirstSubmitQcDate":"2020-09-19","resultsFirstPostDateStruct":{"date":"2020-10-14","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-09-19","lastUpdatePostDateStruct":{"date":"2020-10-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Ana Flávia Barros da Silva Lima","investigatorTitle":"Principal Investigator","investigatorAffiliation":"Federal University of Rio Grande do Sul"},"leadSponsor":{"name":"Federal University of Rio Grande do Sul","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) using medications available in the Brazilian Public Healthcare System (SUS), and assessment of the quality of life of these patients.\n\nA randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of unipolar depression episodes.","detailedDescription":"The study design was that of a pragmatic randomized clinical trial to evaluate the effectiveness of treatments for mood disorders in a public healthcare context in the city of Porto Alegre, in southern Brazil. The algorithm was originally developed for the treatment of major depression by a Delphi panel of experts from psychiatric associations in Brazil. All subjects provided an informed consent form, in writing, in order to participate in the study protocol, which was approved by the institutional ethics committee.\n\nProcedures and measurements of the study\n\nThe subjects under evaluation were selected and they followed the stages defined by the treatment protocol:\n\n1. Sample selection by being referred from the primary healthcare clinics in the municipality;\n2. Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;\n3. Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);\n4. Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;\n5. Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;\n6. In each clinic visit, the severity of the symptoms were evealuated using the Clinical Global Impression Scale (CGI), Hamilton Rating Scale for Depression (HRSD), and Young Manic Rating Scale (YMRS);\n7. Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks."},"conditionsModule":{"conditions":["Depression"],"keywords":["Cost effectiveness","Unipolar Depression","Major Depression Disorder","Quality of life disorder"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SEQUENTIAL","interventionModelDescription":"Patients start treatment according to the algorithm and follow a sequence of steps. There is no comparison between groups. It is a single group. Primary and secondary outcomes are only assessed at the end of the protocol, not at each step.","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":68,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Sertraline","type":"EXPERIMENTAL","description":"Group Started: sertraline (50mg-200mg)\n\nSubjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.\n\nFirst step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.\n\nSecond step: Sertraline 200mg + lithium (900mg-1500mg)\n\nNon responsive patients: 3rd step.\n\nThird step: Nortriptyline 100mg\n\nNon responsive patients: 4th step.\n\nFourth step: Nortriptyline 100mg + lithium (900mg-1500mg)\n\nNon responsive patients : 5th step\n\nFifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients\n\nsixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)","interventionNames":["Drug: sertraline","Drug: Nortriptyline","Drug: Lithium"]}],"interventions":[{"type":"DRUG","name":"sertraline","armGroupLabels":["Sertraline"],"otherNames":["Cloridrate of sertraline"]},{"type":"DRUG","name":"Nortriptyline","armGroupLabels":["Sertraline"],"otherNames":["Cloridrate of nortrytyline"]},{"type":"DRUG","name":"Lithium","armGroupLabels":["Sertraline"],"otherNames":["Lithium Carbonate"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Number of Participants With Response to Treatment","description":"Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD). The HRSD is abbreviated version, consists of 17 items. The cutoff points are: 7-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression .","timeFrame":"8 weeks"}],"secondaryOutcomes":[{"measure":"Number of Participants With Remission to Treatment","description":"The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD \\<7 points) . The subjects that were asymptomatic for at least 6-8 month were considered to be in remission, according to the criteria for partial and complete remission in the DSM-IV.","timeFrame":"8 months"},{"measure":"Quality of Life -WHOQOL Intrument Scores","description":"QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument.\n\nscores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD)","timeFrame":"12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. ages between 18 and 65;\n2. current acute unipolar depression episode;\n3. total capacity to understand and respond to self-applied instruments;\n4. the presence of symptoms in the last 30 days;\n5. abstinence for at least 30 days for drug addicts\n\nExclusion Criteria:\n\n1. presence of Organic Brain Syndrome (OBS);\n2. pregnancy or lactation;\n3. criteria for psychiatric hospitalization.","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Marcelo Fleck, PhD","affiliation":"Federal University of Rio Grande do Sul","role":"PRINCIPAL_INVESTIGATOR"}]},"referencesModule":{"references":[{"pmid":"28832750","type":"DERIVED","citation":"Lima AF, Miguel SR, Cohen M, Zimmermann JJ, Shansis FM, Cruz LN, Ziegelmann PK, Polanczyk CA, Fleck MP. Effectiveness evaluation of mood disorder treatment algorithms in Brazilian public healthcare patients. Braz J Psychiatry. 2018 Jan-Mar;40(1):26-34. doi: 10.1590/1516-4446-2016-2147. Epub 2017 Aug 21."}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Sertraline","description":"Group Started: sertraline (50mg-200mg)\n\nSubjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.\n\nFirst step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.\n\nSecond step: Sertraline 200mg + lithium (900mg-1500mg)\n\nNon responsive patients: 3rd step.\n\nThird step: Nortriptyline 100mg\n\nNon responsive patients: 4th step.\n\nFourth step: Nortriptyline 100mg + lithium (900mg-1500mg)\n\nNon responsive patients : 5th step\n\nFifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients\n\nsixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)\n\nsertraline\n\nNortriptyline\n\nLithium"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"68"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","comment":"Primary and secondary outcomes are assessed just at the end of the protocol, not at each step","numSubjects":"43"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"25"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sertraline","description":"Group Started: sertraline (50mg-200mg)\n\nSubjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.\n\nFirst step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.\n\nSecond step: Sertraline 200mg + lithium (900mg-1500mg)\n\nNon responsive patients: 3rd step.\n\nThird step: Nortriptyline 100mg\n\nNon responsive patients: 4th step.\n\nFourth step: Nortriptyline 100mg + lithium (900mg-1500mg)\n\nNon responsive patients : 5th step\n\nFifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients\n\nsixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)\n\nsertraline\n\nNortriptyline\n\nLithium"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"68"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"40.4","spread":"11.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"53"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"15"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"Brazil","categories":[{"measurements":[{"groupId":"BG000","value":"68"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Number of Participants With Response to Treatment","description":"Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD). The HRSD is abbreviated version, consists of 17 items. The cutoff points are: 7-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression .","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"8 weeks","groups":[{"id":"OG000","title":"Sertraline","description":"Group Started: sertraline (50mg-200mg)\n\nSubjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.\n\nFirst step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.\n\nSecond step: Sertraline 200mg + lithium (900mg-1500mg)\n\nNon responsive patients: 3rd step.\n\nThird step: Nortriptyline 100mg\n\nNon responsive patients: 4th step.\n\nFourth step: Nortriptyline 100mg + lithium (900mg-1500mg)\n\nNon responsive patients : 5th step\n\nFifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients\n\nsixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)\n\nsertraline\n\nNortriptyline\n\nLithium"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"58"}]}]}]},{"type":"SECONDARY","title":"Number of Participants With Remission to Treatment","description":"The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD \\<7 points) . The subjects that were asymptomatic for at least 6-8 month were considered to be in remission, according to the criteria for partial and complete remission in the DSM-IV.","reportingStatus":"POSTED","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","timeFrame":"8 months","groups":[{"id":"OG000","title":"Sertraline","description":"Group Started: sertraline (50mg-200mg)\n\nSubjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.\n\nFirst step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.\n\nSecond step: Sertraline 200mg + lithium (900mg-1500mg)\n\nNon responsive patients: 3rd step.\n\nThird step: Nortriptyline 100mg\n\nNon responsive patients: 4th step.\n\nFourth step: Nortriptyline 100mg + lithium (900mg-1500mg)\n\nNon responsive patients : 5th step\n\nFifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients\n\nsixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)\n\nsertraline\n\nNortriptyline\n\nLithium"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"32"}]}]}]},{"type":"SECONDARY","title":"Quality of Life -WHOQOL Intrument Scores","description":"QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument.\n\nscores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"score on a scale","timeFrame":"12 weeks","groups":[{"id":"OG000","title":"Sertraline","description":"Group Started: sertraline (50mg-200mg)\n\nSubjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.\n\nFirst step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.\n\nSecond step: Sertraline 200mg + lithium (900mg-1500mg)\n\nNon responsive patients: 3rd step.\n\nThird step: Nortriptyline 100mg\n\nNon responsive patients: 4th step.\n\nFourth step: Nortriptyline 100mg + lithium (900mg-1500mg)\n\nNon responsive patients : 5th step\n\nFifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients\n\nsixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)\n\nsertraline\n\nNortriptyline\n\nLithium"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"68"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.45","spread":"3.01"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"18 months","eventGroups":[{"id":"EG000","title":"Sertraline","description":"Group Started: sertraline (50mg-200mg)\n\nSubjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.\n\nFirst step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step.\n\nSecond step: Sertraline 200mg + lithium (900mg-1500mg)\n\nNon responsive patients: 3rd step.\n\nThird step: Nortriptyline 100mg\n\nNon responsive patients: 4th step.\n\nFourth step: Nortriptyline 100mg + lithium (900mg-1500mg)\n\nNon responsive patients : 5th step\n\nFifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients\n\nsixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)\n\nsertraline\n\nNortriptyline\n\nLithium","seriousNumAffected":0,"seriousNumAtRisk":68,"otherNumAffected":0,"otherNumAtRisk":68}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"D.r. Ana Flávia Barros da Silva Lima","organization":"Universidade Federal do Rio Grande do Sul","email":"afbslima@gmail.com.br","phone":"51999185180"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003863","term":"Depression"},{"id":"D003866","term":"Depressive Disorder"}],"ancestors":[{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D020280","term":"Sertraline"},{"id":"D009661","term":"Nortriptyline"},{"id":"D008094","term":"Lithium"},{"id":"D016651","term":"Lithium Carbonate"}],"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"},{"id":"D003986","term":"Dibenzocycloheptenes"},{"id":"D001567","term":"Benzocycloheptenes"},{"id":"D008672","term":"Metals, Alkali"},{"id":"D004602","term":"Elements"},{"id":"D007287","term":"Inorganic Chemicals"},{"id":"D019565","term":"Metals, Light"},{"id":"D008670","term":"Metals"},{"id":"D002254","term":"Carbonates"},{"id":"D000468","term":"Alkalies"},{"id":"D002255","term":"Carbonic Acid"},{"id":"D017554","term":"Carbon Compounds, Inorganic"},{"id":"D018020","term":"Lithium Compounds"}]}},"hasResults":true}