Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT00183404
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Olanzapine Treatment in Children With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-01-11', 'releaseDate': '2017-12-14'}], 'estimatedResultsFirstSubmitDate': '2017-12-14'}}, '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': 'D000077152', 'term': 'Olanzapine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-14', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Psychiatric Rating Scale", 'timeFrame': 'Measured monthly throughout the study'}], 'secondaryOutcomes': [{'measure': 'Aberrant Behavior Checklist', 'timeFrame': 'Measured monthly throughout the study'}, {'measure': 'Clinical Global Impressions', 'timeFrame': 'Measured monthly throughout the study'}, {'measure': 'Treatment Emergent Symptoms Scale', 'timeFrame': 'Measured monthly throughout the study'}, {'measure': 'Olanzapine Untoward Effects Checklist', 'timeFrame': 'Measured monthly throughout the study'}, {'measure': 'Abnormal Involuntary Movement Scale', 'timeFrame': 'Measured monthly throughout the study'}, {'measure': 'Neurological Rating Scale', 'timeFrame': 'Measured monthly throughout the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Drug Treatment', 'Child', 'Olanzapine'], 'conditions': ['Autism']}, 'descriptionModule': {'briefSummary': 'This study will determine the short- and long-term safety and effectiveness of the drug olanzapine (Zyprexa®) for reducing symptoms of autism in children.', 'detailedDescription': 'Autism is a serious childhood disorder that can significantly impair functioning and development. Educational and psychosocial programs are standard treatments for autistic children, but drug therapy is often needed as well. Haloperidol is the drug most commonly prescribed for symptoms of autism. However, long-term administration of haloperidol has been associated with adverse effects such as blurred vision, constipation, and nausea. The investigation of alternative drug treatments is necessary. This study will determine whether the antipsychotic drug olanzapine may be a safe and effective alternative to haloperidol for treating symptoms of autism in children.\n\nThis study will last 36 weeks and will comprise 2 phases. In Phase I, participants will be randomly assigned to receive either olanzapine or placebo for 12 weeks. Participants who do not respond to treatment will complete their participation in the study. Participants who respond to their assigned Phase I treatment will continue onto Phase II. All Phase II participants will receive olanzapine daily for 6 months. Self-report scales and checklists will be used to assess participants after each phase; these measures will be completed by participants and their parents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of autism\n* Parent or guardian willing to provide informed consent\n\nExclusion Criteria:\n\n* Uncontrolled seizure disorder\n* Medical illness other than autism affecting the whole body\n* Obesity\n* History of psychosis\n* Impairment of voluntary movement\n* History of olanzapine treatment'}, 'identificationModule': {'nctId': 'NCT00183404', 'briefTitle': 'Long-Term Olanzapine Treatment in Children With Autism', 'organization': {'class': 'OTHER', 'fullName': 'Drexel University'}, 'officialTitle': 'Long-Term Olanzapine Treatment in Children With Autism', 'orgStudyIdInfo': {'id': 'R01MH073524', 'link': 'https://reporter.nih.gov/quickSearch/R01MH073524', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH073524', 'link': 'https://reporter.nih.gov/quickSearch/R01MH073524', 'type': 'NIH'}, {'id': 'DDTR B2-NDA', 'type': 'OTHER_GRANT', 'domain': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olanzapine', 'description': 'Participants will take open olanzapine for up to 20 additional weeks after phase 1.', 'interventionNames': ['Drug: Olanzapine']}], 'interventions': [{'name': 'Olanzapine', 'type': 'DRUG', 'otherNames': ['Open Olanzapine'], 'description': 'Olanzapine tablets, dosed once or twice per day, dosage 2.5 to 20 mg per day', 'armGroupLabels': ['Olanzapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19124', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Drexel University College of Medicine at Friends Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Richard P. Malone, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Drexel University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drexel University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-12-14', 'type': 'RELEASE'}, {'date': '2018-01-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Drexel University'}}}}