{"protocolSection":{"identificationModule":{"nctId":"NCT02357849","orgStudyIdInfo":{"id":"11-199"},"organization":{"fullName":"Northwell Health","class":"OTHER"},"briefTitle":"Fluoxetine vs Aripiprazole Comparative Trial (FACT)","officialTitle":"The Role of Antidepressants or Antipsychotics in Preventing Psychosis: Fluoxetine vs Aripiprazole Comparative Trial (FACT)","acronym":"FACT"},"statusModule":{"statusVerifiedDate":"2023-10","overallStatus":"TERMINATED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2014-07"},"primaryCompletionDateStruct":{"date":"2022-04-04","type":"ACTUAL"},"completionDateStruct":{"date":"2022-04-04","type":"ACTUAL"},"studyFirstSubmitDate":"2014-09-30","studyFirstSubmitQcDate":"2015-02-05","studyFirstPostDateStruct":{"date":"2015-02-06","type":"ESTIMATED"},"resultsFirstSubmitDate":"2023-10-05","resultsFirstSubmitQcDate":"2023-10-27","resultsFirstPostDateStruct":{"date":"2023-11-15","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-10-27","lastUpdatePostDateStruct":{"date":"2023-11-15","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Christoph U. Correll, MD","investigatorTitle":"Professor of Psychiatry and Molecular Medicine Hofstra North Shore LIJ School of Medicine","investigatorAffiliation":"Northwell Health"},"leadSponsor":{"name":"Northwell Health","class":"OTHER"}},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"We are conducting a randomized, 24-week, double-blind study, comparing fluoxetine with aripiprazole in 48 patients with attenuated positive symptoms at a level of at least moderate severity.","detailedDescription":"To Compare Fluoxetine and Aripiprazole on All-cause Discontinuation/Need to Add Another Psychiatric Medication, Symptomatic Improvement, and Adverse Effects"},"conditionsModule":{"conditions":["Attenuated Psychosis Syndrome"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"OTHER","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":9,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Aripiprazole","type":"ACTIVE_COMPARATOR","description":"To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (2mg wk1, 5mg wk2, 10mg wk3, 5-30 mg wk4-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need (5-30mg).","interventionNames":["Drug: Aripiprazole"]},{"label":"Fluoxetine","type":"ACTIVE_COMPARATOR","description":"To increase homogeneity and assure treatment with a clinically effective dose, patients will undergo a fixed titration phase during the first four weeks (5mg wk1, 10mg wk2, 20mg wk3, 10-60mg wk3-24), with the option to slow or halt the titration or decrease the target dose if intolerability develops. After 3 weeks, dosing will be flexible and left up to clinical choice and need(10-60mg).","interventionNames":["Drug: Fluoxetine"]}],"interventions":[{"type":"DRUG","name":"Aripiprazole","description":"see arm description","armGroupLabels":["Aripiprazole"],"otherNames":["Abilify"]},{"type":"DRUG","name":"Fluoxetine","description":"see arm description","armGroupLabels":["Fluoxetine"],"otherNames":["Prozac"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to Treatment Failure","description":"Time to either all-cause-discontinuation or need to add another psychotropic agent","timeFrame":"24 weeks"}],"secondaryOutcomes":[{"measure":"Change in Prodromal Symptoms (SOPS) Total Scores","description":"Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse)","timeFrame":"24 weeks"},{"measure":"Number of Patients With Specific Adverse Effects","description":"Number of patients with any adverse effects based on spontaneous report","timeFrame":"24 weeks"},{"measure":"Change in Social and Role Functioning Scores","description":"Change in social and role functioning scores (range: 0-10, higher sores = better outcome)","timeFrame":"24 weeks"},{"measure":"Subjective Well-being Questionnaire","description":"Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being)","timeFrame":"24 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* consent obtained from patients and their parents (assent for patients under 18);\n* age 12-25 years (inclusive);\n* English-speaking;\n* at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe.\n\nExclusion Criteria:\n\n* lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features;\n* current psychosis (any positive symptom SOPS score of 6, i.e., extreme);\n* current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features;\n* current stimulant treatment;\n* history of neurological, neuroendocrine or other medical condition known to affect the brain;\n* any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine;\n* past or current substance dependence; sunstance abuse within the last 4 weeks;\n* IQ \\< 70.","healthyVolunteers":false,"sex":"ALL","minimumAge":"12 Years","maximumAge":"25 Years","stdAges":["CHILD","ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Christoph U Correll, MD","affiliation":"North Shore LIJ","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"The Zucker Hillside Hospital","city":"Glen Oaks","state":"New York","zip":"11004","country":"United States","geoPoint":{"lat":40.74705,"lon":-73.71152}}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"outpatient clinic","groups":[{"id":"FG000","title":"Aripiprazole","description":"Intervention arm"},{"id":"FG001","title":"Fluoxetine","description":"Active control arm"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Aripiprazole","description":"Intervention arm"},{"id":"BG001","title":"Fluoxetine","description":"Active control arm"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}]},{"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":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15.5","spread":"1.3"},{"groupId":"BG001","value":"16.0","spread":"1.7"},{"groupId":"BG002","value":"15.8","spread":"1.6"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]}]}]},{"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":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"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":"1"},{"groupId":"BG002","value":"2"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]},{"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":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}]}]}]},{"title":"Treatment Failure","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time to Treatment Failure","description":"Time to either all-cause-discontinuation or need to add another psychotropic agent","populationDescription":"Data was not collected","reportingStatus":"POSTED","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Aripiprazole","description":"Intervention arm"},{"id":"OG001","title":"Fluoxetine","description":"Active control arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Change in Prodromal Symptoms (SOPS) Total Scores","description":"Change in Prodromal Symptoms (SOPS) total scores (range: 0-30, higher = worse)","populationDescription":"Data was not collected","reportingStatus":"POSTED","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Aripiprazole","description":"Intervention arm"},{"id":"OG001","title":"Fluoxetine","description":"Active control arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Number of Patients With Specific Adverse Effects","description":"Number of patients with any adverse effects based on spontaneous report","populationDescription":"Data was not collected","reportingStatus":"POSTED","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Aripiprazole","description":"Intervention arm"},{"id":"OG001","title":"Fluoxetine","description":"Active control arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Change in Social and Role Functioning Scores","description":"Change in social and role functioning scores (range: 0-10, higher sores = better outcome)","populationDescription":"Data was not collected","reportingStatus":"POSTED","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Aripiprazole","description":"Intervention arm"},{"id":"OG001","title":"Fluoxetine","description":"Active control arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]},{"type":"SECONDARY","title":"Subjective Well-being Questionnaire","description":"Subjective well-being questionnaire (Total score rang: 20-120, with higher scores indicating greater well-being)","populationDescription":"Data was not collected","reportingStatus":"POSTED","timeFrame":"24 weeks","groups":[{"id":"OG000","title":"Aripiprazole","description":"Intervention arm"},{"id":"OG001","title":"Fluoxetine","description":"Active control arm"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"6 months","eventGroups":[{"id":"EG000","title":"Aripiprazole","description":"Intervention arm","deathsNumAffected":0,"deathsNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"otherNumAffected":0,"otherNumAtRisk":4},{"id":"EG001","title":"Fluoxetine","description":"Active control arm","deathsNumAffected":0,"deathsNumAtRisk":5,"seriousNumAffected":0,"seriousNumAtRisk":5,"otherNumAffected":0,"otherNumAtRisk":5}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Christoph Correll","organization":"Northwell Health","email":"ccorrell@northwell.edu","phone":"718-470","phoneExt":"7000"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2016-03-09","uploadDate":"2023-10-27T14:12","filename":"Prot_SAP_000.pdf","size":401769},{"typeAbbrev":"ICF","hasProtocol":false,"hasSap":false,"hasIcf":true,"label":"Informed Consent Form","date":"2016-09-02","uploadDate":"2023-10-05T14:45","filename":"ICF_001.pdf","size":336037}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D000068180","term":"Aripiprazole"},{"id":"D005473","term":"Fluoxetine"}],"ancestors":[{"id":"D010879","term":"Piperazines"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D015363","term":"Quinolones"},{"id":"D011804","term":"Quinolines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}