{"protocolSection":{"identificationModule":{"nctId":"NCT02520726","orgStudyIdInfo":{"id":"UUtahIRB0062412"},"organization":{"fullName":"University of Utah","class":"OTHER"},"briefTitle":"PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims","officialTitle":"A Randomized, Double-blind, Placebo-controlled Pilot Study of Sertraline for the Prevention of PTSD in Burn Victims"},"statusModule":{"statusVerifiedDate":"2017-12","overallStatus":"TERMINATED","whyStopped":"Insufficient enrollment","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-09"},"primaryCompletionDateStruct":{"date":"2016-09","type":"ACTUAL"},"completionDateStruct":{"date":"2016-09","type":"ACTUAL"},"studyFirstSubmitDate":"2014-04-18","studyFirstSubmitQcDate":"2015-08-11","studyFirstPostDateStruct":{"date":"2015-08-13","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-12-05","resultsFirstSubmitQcDate":"2018-03-13","resultsFirstPostDateStruct":{"date":"2018-04-10","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-03-13","lastUpdatePostDateStruct":{"date":"2018-04-10","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Brent Kious","investigatorTitle":"Psychiatry Resident","investigatorAffiliation":"University of Utah"},"leadSponsor":{"name":"University of Utah","class":"OTHER"}},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"This is a randomized, double-blind, placebo-controlled study to determine whether administration of sertraline to patients who exhibit acute stress disorder secondary to severe burns can contribute to the prevention of post-traumatic stress disorder (PTSD)."},"conditionsModule":{"conditions":["Post-traumatic Stress Disorder"],"keywords":["Posttraumatic stress disorder","PTSD","Sertraline","Burns"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":5,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Sertraline","type":"EXPERIMENTAL","description":"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age \\>65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration","interventionNames":["Drug: Sertraline"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.","interventionNames":["Drug: Placebo oral capsule"]}],"interventions":[{"type":"DRUG","name":"Sertraline","description":"\\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.","armGroupLabels":["Sertraline"],"otherNames":["Zoloft"]},{"type":"DRUG","name":"Placebo oral capsule","description":"Matched encapsulated placebo from 1-4 capsules daily","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Clinician-Administered PTSD Scale","timeFrame":"Month"}],"secondaryOutcomes":[{"measure":"Beck Scale for Suicide Ideation","timeFrame":"1 month"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Victim of a traumatic event leading to personal injury\n* Patient experienced a feeling of intense fear, hopelessness, or horror during the course of the event or immediately afterward\n* Positive screen on the ASDS (for inclusion in the randomization phase); a total ASDS score of ≥ 37 (including a dissociative score of ≥ 9) will be counted as a positive screen.\n\nExclusion Criteria:\n\n* Age \\< 18\n* Pregnant women, lactating women, or women not using acceptable form of birth control\n* Epilepsy or head trauma resulting in seizures\n* Current or historical schizophrenia, bipolar disorder, mental retardation, OCD, eating disorders, dementia, delirium, or self-injurious behavior\n* Current/previously diagnosed PTSD\n* History of hypersensitivity to sertraline\n* Trauma occurring \\> 7 days prior to likely first treatment in the randomization phase of the trial.\n* Unable to provide informed consent for participation in the study protocol.\n* Patient at high risk of recurrent bleeding despite surgical stabilization\n* Patient with a history of serotonin syndrome\n* Patient non-fluent in English\n* Patient currently prescribed an antidepressant (any SSRI, SNRI, TCA, MAOI, mirtazapine, or trazodone in excess of 100mg per day)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Brent M Kious, MD PhD","affiliation":"University of Utah","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Utah Hospital","city":"Salt Lake City","state":"Utah","zip":"84132","country":"United States","geoPoint":{"lat":40.76078,"lon":-111.89105}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Sertraline","description":"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age \\>65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."},{"id":"FG001","title":"Placebo","description":"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Sertraline","description":"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age \\>65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."},{"id":"BG001","title":"Placebo","description":"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}],"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"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]}]}]},{"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":"0"},{"groupId":"BG002","value":"0"}]},{"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":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]},{"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":"3"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"5"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Clinician-Administered PTSD Scale","populationDescription":"All subjects lost to follow-up","reportingStatus":"POSTED","timeFrame":"Month","groups":[{"id":"OG000","title":"Sertraline","description":"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age \\>65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."},{"id":"OG001","title":"Placebo","description":"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Beck Scale for Suicide Ideation","populationDescription":"All subjects lost to follow-up","reportingStatus":"POSTED","timeFrame":"1 month","groups":[{"id":"OG000","title":"Sertraline","description":"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age \\>65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."},{"id":"OG001","title":"Placebo","description":"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","eventGroups":[{"id":"EG000","title":"Sertraline","description":"Patients age 18-65: sertraline 50mg PO qday for one week, then 100mg PO qday for one week, then 150mg PO qday for one week, then 200mg PO qday for one week, with flexible titration. Patient age \\>65: sertraline 25mg PO qday for one week, then 50mg PO qday for one week, then 75mg PO qday for one week, then 100mg PO qday for one week, with flexible titration\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.","seriousNumAffected":0,"seriousNumAtRisk":3,"otherNumAffected":0,"otherNumAtRisk":3},{"id":"EG001","title":"Placebo","description":"Placebo 1 capsule PO qday for one week, then 2 capsules PO qday for one week, then 3 capsules PO qday for one week, then 4 capsules PO qday for one week.\n\nSertraline: \\< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.","seriousNumAffected":0,"seriousNumAtRisk":2,"otherNumAffected":0,"otherNumAtRisk":2}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Brent Kious, MD","organization":"University of Utah","email":"brent.kious@hsc.utah.edu","phone":"801-585-1418"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D013313","term":"Stress Disorders, Post-Traumatic"},{"id":"D002056","term":"Burns"}],"ancestors":[{"id":"D040921","term":"Stress Disorders, Traumatic"},{"id":"D000068099","term":"Trauma and Stressor Related Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D014947","term":"Wounds and Injuries"}]},"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}