Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00515320
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2007-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Fluoxetine in Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-06-19', 'releaseDate': '2013-04-30'}], 'estimatedResultsFirstSubmitDate': '2013-04-30'}}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-26', 'studyFirstSubmitDate': '2007-08-10', 'studyFirstSubmitQcDate': '2007-08-10', 'lastUpdatePostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.', 'timeFrame': 'Throughout the study'}], 'secondaryOutcomes': [{'measure': 'The time and dose related course of therapeutic effects', 'timeFrame': 'Throughout the study'}, {'measure': 'The inter-relationship between these effects in the context of global clinical changes.', 'timeFrame': 'Throughout the study'}, {'measure': 'The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.', 'timeFrame': 'Throughout the study'}, {'measure': 'Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autism', 'children', 'adolescent', 'Fluoxetine', 'Autistic Disorder', 'Repetitive behavior', 'SSRI', 'Selective Serotonin Reuptake Inhibitor'], 'conditions': ['Autistic Disorder']}, '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.'}, {'pmid': '31267292', 'type': 'DERIVED', 'citation': 'Herscu P, Handen BL, Arnold LE, Snape MF, Bregman JD, Ginsberg L, Hendren R, Kolevzon A, Melmed R, Mintz M, Minshew N, Sikich L, Attalla A, King B, Owley T, Childress A, Chugani H, Frazier J, Cartwright C, Murphy T; Autism Speaks Autism Clinical Trials Network. The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder. J Autism Dev Disord. 2020 Sep;50(9):3233-3244. doi: 10.1007/s10803-019-04120-y.'}], 'seeAlsoLinks': [{'url': 'http://www.autismspeaks.org', 'label': 'www.autismspeaks.org'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets DSM-IV criteria for autistic disorder, .\n* CYBOCS-PDD score of at least 10 at screening.\n\nExclusion Criteria:\n\n* Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.\n* Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.\n* Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.\n\nOther protocol-defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00515320', 'acronym': 'SOFIA', 'briefTitle': 'Study of Fluoxetine in Autism', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neuropharm'}, 'officialTitle': 'Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.', 'orgStudyIdInfo': {'id': 'NPL-2008-4-AUTUS-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoxetine', 'interventionNames': ['Drug: Fluoxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Fluoxetine', 'type': 'DRUG', 'otherNames': ['NPL-2008'], 'description': 'Once daily oral dispersible tablet 2mg 9mg or 18mg', 'armGroupLabels': ['Fluoxetine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral dispersible tablet placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Autism Research and Resource Centre', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida, Department of Psychiatry', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '30080', 'city': 'Smyrna', 'state': 'Georgia', 'country': 'United States', 'facility': 'Institute for Behavioral Medicine', 'geoPoint': {'lat': 33.88399, 'lon': -84.51438}}, {'zip': '60637-1448', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60563', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'AMR-Baber Research Inc.', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}, {'zip': '02155', 'city': 'Medford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Harvard Medical School', 'geoPoint': {'lat': 42.41843, 'lon': -71.10616}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': "Children's Hospital of Michigan", 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Center for Psychiatry and Behavioral Medicine', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'facility': 'CRCNJ', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '11714', 'city': 'Bethpage', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Hospital', 'geoPoint': {'lat': 40.74427, 'lon': -73.48207}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '15203', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Western Psychiatric Institute and Clinic/ Merck Child Outpatient Clinic', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Red Oak Psychiatry Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98105-0371', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hosptial University of Washington", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neuropharm', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Autism Speaks', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-04-30', 'type': 'RELEASE'}, {'date': '2013-06-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Neuropharm'}}}}