{"protocolSection":{"identificationModule":{"nctId":"NCT01223001","orgStudyIdInfo":{"id":"RHI 05-096"},"secondaryIdInfos":[{"id":"F1J-US-X025","type":"OTHER","domain":"Eli Lilly and Co."}],"organization":{"fullName":"Rehabilitation Hospital of Indiana","class":"OTHER"},"briefTitle":"Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury","officialTitle":"Prevention of Depression and Enhancement of Cognitive Recovery Following Traumatic Brain Injury With Duloxetine","acronym":"Duloxetine"},"statusModule":{"statusVerifiedDate":"2014-11","overallStatus":"TERMINATED","whyStopped":"Most potential subjects had already been prescribed Cymbalta.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"1996-09"},"primaryCompletionDateStruct":{"date":"2011-07","type":"ACTUAL"},"completionDateStruct":{"date":"2011-07","type":"ACTUAL"},"studyFirstSubmitDate":"2010-10-15","studyFirstSubmitQcDate":"2010-10-15","studyFirstPostDateStruct":{"date":"2010-10-18","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-11-06","resultsFirstSubmitQcDate":"2014-12-15","resultsFirstPostDateStruct":{"date":"2014-12-17","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-12-15","lastUpdatePostDateStruct":{"date":"2014-12-17","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Rehabilitation Hospital of Indiana","class":"OTHER"},"collaborators":[{"name":"Eli Lilly and Company","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.","detailedDescription":"The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function. Research exploring the use of selective serotonin reuptake inhibitors in the treatment of post-traumatic depression generally validates this approach (Horsfield et al., 2002). However, the literature suggests that serotonin/norepinephrine reuptake inhibitors such as duloxetine may be more effective in the treatment of depression."},"conditionsModule":{"conditions":["Traumatic Brain Injury","Depression"],"keywords":["Depression","Traumatic brain injury","Duloxetine","Cymbalta","impaired cognitive function"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":8,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"ACTIVE_COMPARATOR","description":"Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.","interventionNames":["Drug: Duloxetine"]},{"label":"Sugar pill","type":"PLACEBO_COMPARATOR","description":"Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.","interventionNames":["Drug: Sugar pill"]}],"interventions":[{"type":"DRUG","name":"Duloxetine","description":"Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta"]},{"type":"DRUG","name":"Sugar pill","description":"Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.","armGroupLabels":["Sugar pill"],"otherNames":["Lactose"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Hamilton Rating Scale for Depression","description":"To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.","timeFrame":"9 months"}],"secondaryOutcomes":[{"measure":"Hopkins Verbal Learning Test","description":"To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.","timeFrame":"9 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Study participants will be 40 men and women between the ages of 18 and 75 who provide appropriate consent and who are agreeable to study requirements\n* Diagnosed with mild to moderate traumatic brain injury as defined by an initial Mayo Traumatic Brain Injury Severity Scale\n* Have memory impairments defined by a Hopkins Verbal Learning Test delayed recall score which falls less than or equal to 1.5 standard deviation below the mean.\n\nExclusion Criteria:\n\n* Refusal to give informed consent\n* A previous Central Nervous System illness or injury, including seizure that exhibits residual symptoms.\n* Current post-traumatic seizure disorder\n* A previous diagnosis of a psychotic disorder\n* Current or previous (in the last 6 months) treatment history for alcohol or substance dependency\n* Medications affecting noradrenergic or dopaminergic systems, alpha-adrenergic antihypertensives, antidepressant, phenobarbital, Monoamine oxidase inhibitor (MAOI), scheduled benzodiazepines, psychoactive herbal supplements (including Kava, St. John's wort), or nutritional supplements or within at least 14 days of discontinuing treatment with the above medications or supplements.\n* A known suicide risk\n* A pregnant or breastfeeding woman\n* Uncontrolled narrow-angle glaucoma\n* Serious and/or unstable medical comorbidity (e.g., AIDS, cancer, history of uncontrolled hypertension or cardiovascular disease) psychological condition, or clinically significant laboratory abnormality that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study\n* Liver enzymes \\> 1.5 times upper limit of normal\n* Patients with end-stage renal disease (requiring dialysis) or severe renal impairment\n* Known hypersensitivity to duloxetine or any of the inactive ingredients","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Lance Trexler, Ph.D.","affiliation":"Rehabilitation Hospital of Indiana","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Rehabilitation Hospital of Indiana","city":"Indianapolis","state":"Indiana","zip":"46254","country":"United States","geoPoint":{"lat":39.76838,"lon":-86.15804}}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"All subjects performed cognitive testing and assessment for depression. No subjects with seizure disorder or substance abuse issues or previous psychiatric history enrolled. Subjects excluded from the study had previously been prescribed Duloxetine.","recruitmentDetails":"Subjects recruited from in-patient and medical clinic population. All subjects suffering from traumatic brain injury and loss of cognitive function.","groups":[{"id":"FG000","title":"Duloxetine","description":"Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously."},{"id":"FG001","title":"Sugar Pill","description":"Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine","description":"Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously."},{"id":"BG001","title":"Sugar Pill","description":"Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}],"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":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]},{"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":"4"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"7"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"8"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Hamilton Rating Scale for Depression","description":"To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.","populationDescription":"Analysis was not conducted. Study was terminated before interim analysis. Raw data is stored in a secure location, but not able to be accessed.","reportingStatus":"POSTED","timeFrame":"9 months","groups":[{"id":"OG000","title":"Duloxetine","description":"Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously."},{"id":"OG001","title":"Sugar Pill","description":"Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Hopkins Verbal Learning Test","description":"To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.","reportingStatus":"NOT_POSTED","timeFrame":"9 months"}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Duration of study participation per subject.","description":"Subjects did not experience adverse events of any type.","eventGroups":[{"id":"EG000","title":"Duloxetine","description":"Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.","seriousNumAffected":0,"seriousNumAtRisk":4,"otherNumAffected":0,"otherNumAtRisk":4},{"id":"EG001","title":"Sugar Pill","description":"Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.","seriousNumAffected":0,"seriousNumAtRisk":4,"otherNumAffected":0,"otherNumAtRisk":4}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"All subjects excluded (n=6) had already been prescribed Duloxetine. Completion of the study by the remaining 4 per group was not achieved due to noncompliance."},"certainAgreement":{"piSponsorEmployee":false,"restrictionType":"GT60","restrictiveAgreement":true},"pointOfContact":{"title":"Dr. Lance Trexler","organization":"The Rehabilitation Hospital of Indiana","email":"lance.trexler@rhin.com","phone":"(317)879-8940"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D000070642","term":"Brain Injuries, Traumatic"},{"id":"D003863","term":"Depression"}],"ancestors":[{"id":"D001930","term":"Brain Injuries"},{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D006259","term":"Craniocerebral Trauma"},{"id":"D020196","term":"Trauma, Nervous System"},{"id":"D014947","term":"Wounds and Injuries"},{"id":"D001526","term":"Behavioral Symptoms"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068736","term":"Duloxetine Hydrochloride"},{"id":"D000073893","term":"Sugars"},{"id":"D007785","term":"Lactose"}],"ancestors":[{"id":"D013876","term":"Thiophenes"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D002241","term":"Carbohydrates"},{"id":"D004187","term":"Disaccharides"},{"id":"D009844","term":"Oligosaccharides"},{"id":"D011134","term":"Polysaccharides"}]}},"hasResults":true}