{"protocolSection":{"identificationModule":{"nctId":"NCT00183339","orgStudyIdInfo":{"id":"U54MH066418","type":"NIH","link":"https://reporter.nih.gov/quickSearch/U54MH066418"},"secondaryIdInfos":[{"id":"U54MH066418","type":"NIH","link":"https://reporter.nih.gov/quickSearch/U54MH066418"}],"organization":{"fullName":"University of North Carolina, Chapel Hill","class":"OTHER"},"briefTitle":"Early Intervention With Fluoxetine in Autism","officialTitle":"A Randomized, Placebo-controlled Trial of Fluoxetine in Preschool Children"},"statusModule":{"statusVerifiedDate":"2014-02","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2005-07"},"primaryCompletionDateStruct":{"date":"2008-02","type":"ACTUAL"},"completionDateStruct":{"date":"2008-02","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-06","studyFirstSubmitQcDate":"2005-09-12","studyFirstPostDateStruct":{"date":"2005-09-16","type":"ESTIMATED"},"resultsFirstSubmitDate":"2013-09-10","resultsFirstSubmitQcDate":"2014-02-07","resultsFirstPostDateStruct":{"date":"2014-03-26","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-02-07","lastUpdatePostDateStruct":{"date":"2014-03-26","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Linmarie Sikich, MD","investigatorTitle":"Associate Professor","investigatorAffiliation":"University of North Carolina, Chapel Hill"},"leadSponsor":{"name":"University of North Carolina, Chapel Hill","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism.","detailedDescription":"Autism, a brain disorder that affects a small percentage of Americans, often results in a lifetime of impaired thinking, feeling, and social functioning. The disorder generally becomes apparent in children by the age of 3. Autism typically affects a person's ability to communicate, form relationships with others, and respond appropriately to the external world. Some people with autism can function at a relatively high level, with speech and intelligence intact. Others have serious cognitive impairments and language delays, and some never speak. This study will assess the safety and effectiveness of treating autistic children with fluoxetine to enhance developmental processes in core areas impacted by autism.\n\nEach participant was randomly assigned to treatment with double-blinded placebo or fluoxetine for 12 months. After initial screening and randomization, participants were assessed every two weeks for approximately the first 3 months, or until the dose of medication is stabilized. After this initial period, they were assessed on a monthly basis. Dosing was flexible as determined by the adverse and beneficial responses to treatment although there was a suggested titration schedule."},"conditionsModule":{"conditions":["Autistic Disorder"],"keywords":["Autism"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":18,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo, liquid solution flexible dose 0.5 to 5ml every morning (AM)","interventionNames":["Drug: Placebo"]},{"label":"fluoxetine","type":"EXPERIMENTAL","description":"Fluoxetine, 20mg/5ml solution, flexible dose 0.5 to 5ml every AM","interventionNames":["Drug: Fluoxetine"]}],"interventions":[{"type":"DRUG","name":"Fluoxetine","description":"Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.","armGroupLabels":["fluoxetine"],"otherNames":["Prozac"]},{"type":"DRUG","name":"Placebo","description":"Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Rate of Recruitment","description":"In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment\\* 2sites ) /\\[ # participants randomized \\] and compared it to the typical # of months required to recruit an older child with ASD for a double-blind 12 week placebo controlled medication study, which is typically about 1.2 months at each of the sites involved in the study.","timeFrame":"19 months"}],"secondaryOutcomes":[{"measure":"Rate of Attrition","description":"The percentage of participants who discontinued treatment prior to completion of the 12 month study","timeFrame":"Measured at Month 12"},{"measure":"Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire","description":"This is a caregiver completed measure that assesses the extent to which the caregiver feels care of the participant influences the caregiver's and other family members' emotional states and/or activities. There are a total of 22 items rated from 1 - not at all to 5 - very much (with one item reverse scored). Total score is the sum of all the items (with one item reverse scored). There are three subscales objective strain -12 items, internalized subjective strain 6 items, externalized subjective 4 items. The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.","timeFrame":"12 months"},{"measure":"Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)","description":"The Aberrant Behavior Checklist (ABC) is a caregiver completed rating scale that assesses problem behaviors frequently seen in individuals with developmental disabilities. There are a total of 58 items on 5 subscales that are rated from 0 - not at all a problem to 3 - problem is severe in degree. The ABC-I consists of 15 items that reflect mood swings, self-injury and aggression. The subscale score is the sum of the score on each of the 15 items. The minimum score on the ABC-I is 0 and the maximum score is 45. Higher scores reflect more severe behavioral problems. A score \\> or = to 18 is generally considered clinically significant.","timeFrame":"12 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of autism\n\nExclusion Criteria:\n\n* Diagnosis of Asperger Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or Pervasive Development Disorder-Not Otherwise Specified\n* Informed that treatment with a selective serotonin reuptake inhibitor (SSRI) is medically inadvisable\n* Need for ongoing psychotropic medication (except for diphenhydramine, clonidine, or melatonin for sleep)\n* Recent use of stimulants within 5 days prior to enrollment\n* Ongoing need for or recent use of most psychotropic medications within 14 days of enrollment\n* Recent initiation of specialized educational, behavioral, or diet intervention for autism in the month prior to enrollment","healthyVolunteers":false,"sex":"ALL","minimumAge":"30 Months","maximumAge":"58 Months","stdAges":["CHILD"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Linmarie Sikich, MD","affiliation":"University of North Carolina, Chapel Hill","role":"STUDY_CHAIR"}],"locations":[{"facility":"Mount Sinai School of Medicine","city":"New York","state":"New York","zip":"10029","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"University of North Carolina, Chapel Hill","city":"Chapel Hill","state":"North Carolina","zip":"25714","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}}]},"referencesModule":{"references":[{"pmid":"37811711","type":"DERIVED","citation":"Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2."}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Placebo","description":"Participants who received placebo solution between .5ml and 5.0ml"},{"id":"FG001","title":"Fluoxetine","description":"Participants who received liquid fluoxetine 2-20 mg (of 4mg/1ml solution) in AM using a flexible dose strategy and planned 36 week titration schedule"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"8"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Placebo","description":"Participants will take the placebo"},{"id":"BG001","title":"Fluoxetine","description":"Participants will take liquid fluoxetine 2-20 mg"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"18"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"18"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"months","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"44.0","spread":"6.6"},{"groupId":"BG001","value":"42.6","spread":"8.1"},{"groupId":"BG002","value":"43.4","spread":"7.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"18"}]}]}]},{"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":"1"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"2"}]},{"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":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"12"}]},{"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":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"18"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Rate of Recruitment","description":"In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment\\* 2sites ) /\\[ # participants randomized \\] and compared it to the typical # of months required to recruit an older child with ASD for a double-blind 12 week placebo controlled medication study, which is typically about 1.2 months at each of the sites involved in the study.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"months/participant at 1 site","timeFrame":"19 months","groups":[{"id":"OG000","title":"Placebo","description":"Participants will take the placebo"},{"id":"OG001","title":"Fluoxetine","description":"Participants will take liquid fluoxetine 2-20 mg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.1"},{"groupId":"OG001","value":"2.1"}]}]}]},{"type":"SECONDARY","title":"Rate of Attrition","description":"The percentage of participants who discontinued treatment prior to completion of the 12 month study","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percent of group that discontinued early","timeFrame":"Measured at Month 12","groups":[{"id":"OG000","title":"Placebo","description":"participants who were treated with flexible dose placebo solution"},{"id":"OG001","title":"Fluoxetine","description":"Participants treated with flexible dose fluoxetine solution"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"50"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire","description":"This is a caregiver completed measure that assesses the extent to which the caregiver feels care of the participant influences the caregiver's and other family members' emotional states and/or activities. There are a total of 22 items rated from 1 - not at all to 5 - very much (with one item reverse scored). Total score is the sum of all the items (with one item reverse scored). There are three subscales objective strain -12 items, internalized subjective strain 6 items, externalized subjective 4 items. The total score can range from a minimum of 0 - no strain at all, to 110 all items rated as very much.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"12 months","groups":[{"id":"OG000","title":"Placebo","description":"participants who were treated with flexible dose placebo solution"},{"id":"OG001","title":"Fluoxetine","description":"participants who were treated with flexible dose (2-20mg/D) fluoxetine solution"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"2.5"},{"groupId":"OG001","value":"-1.86","spread":"2.3"}]}]}]},{"type":"SECONDARY","title":"Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)","description":"The Aberrant Behavior Checklist (ABC) is a caregiver completed rating scale that assesses problem behaviors frequently seen in individuals with developmental disabilities. There are a total of 58 items on 5 subscales that are rated from 0 - not at all a problem to 3 - problem is severe in degree. The ABC-I consists of 15 items that reflect mood swings, self-injury and aggression. The subscale score is the sum of the score on each of the 15 items. The minimum score on the ABC-I is 0 and the maximum score is 45. Higher scores reflect more severe behavioral problems. A score \\> or = to 18 is generally considered clinically significant.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"12 months","groups":[{"id":"OG000","title":"Placebo","description":"Participants will take the placebo"},{"id":"OG001","title":"Fluoxetine","description":"Participants will take liquid fluoxetine 2-20 mg"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.70","spread":"2.9"},{"groupId":"OG001","value":"-8.50","spread":"10.6"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"12 months (The course of treatment for each participant in the trial)","eventGroups":[{"id":"EG000","title":"Placebo","description":"participants who were treated with flexible dose placebo 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disorders","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8}]},{"term":"Cold/Flu/other systemic infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":7,"numAtRisk":10},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":8}]},{"term":"Earache","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":10},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":8}]},{"term":"other eye disorders","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":3,"numAffected":3,"numAtRisk":8}]},{"term":"gastroenteritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":6,"numAtRisk":10},{"groupId":"EG001","numEvents":6,"numAffected":6,"numAtRisk":8}]},{"term":"allergies","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":10},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":8}]},{"term":"intentional injury","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8}]},{"term":"Local Infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8}]},{"term":"weight increased","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":8}]},{"term":"aggression","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":4,"numAtRisk":10},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":8}]},{"term":"Other infection","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":10},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":8}]},{"term":"enuresis","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":10},{"groupId":"EG001","numEvents":5,"numAffected":5,"numAtRisk":8}]},{"term":"cough","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 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(11.1)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":3,"numAffected":3,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":8}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"It took twice as long to recruit subjects for a study in children 30-58 months than it generally takes to recruit older children. It is possible to maintain subjects in double-blind trails for extended periods."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Linmarie Sikich, MD","organization":"University of North Carolina","email":"Lsikich@med.unc.edu","phone":"919 966 8653"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D001321","term":"Autistic Disorder"}],"ancestors":[{"id":"D000067877","term":"Autism Spectrum Disorder"},{"id":"D002659","term":"Child Development Disorders, Pervasive"},{"id":"D065886","term":"Neurodevelopmental Disorders"},{"id":"D001523","term":"Mental Disorders"}]},"interventionBrowseModule":{"meshes":[{"id":"D005473","term":"Fluoxetine"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}