Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-27 @ 4:06 PM
Study NCT ID:
NCT00937261
Status:
UNKNOWN
Last Update Posted:
2010-10-28
First Post:
2009-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2013-09-03', 'releaseDate': '2013-06-19'}, {'resetDate': '2017-03-14', 'releaseDate': '2017-01-25'}, {'resetDate': '2021-01-21', 'releaseDate': '2021-01-20'}, {'resetDate': '2021-05-26', 'releaseDate': '2021-05-04'}, {'resetDate': '2021-07-01', 'releaseDate': '2021-06-11'}, {'resetDate': '2024-10-09', 'releaseDate': '2024-09-16'}, {'resetDate': '2025-01-13', 'releaseDate': '2025-01-09'}, {'resetDate': '2025-08-08', 'releaseDate': '2025-08-04'}], 'estimatedResultsFirstSubmitDate': '2013-06-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D000068882', 'term': 'Paliperidone Palmitate'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-27', 'studyFirstSubmitDate': '2009-07-07', 'studyFirstSubmitQcDate': '2009-07-08', 'lastUpdatePostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal', 'timeFrame': 'approximately 6-10 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand brain function and psychiatric and neurological illness when taking Invega or Risperdal. The objective is to compare the brain effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be evaluated with PET imaging, fMRI, and neurological ratings and assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are currently taking Risperdal and have been on the medication for at least three weeks\n* are diagnosed with schizophrenia\n* are able to provide written informed consent\n* can safely have an MRI\n\nExclusion Criteria:\n\n* are treatment resistant or intolerant to Risperdal\n* have participated in another drug study in the past 28 days\n* are pregnant or trying to become pregnant or are breastfeeding\n* are colorblind\n* have a history of alcohol, cannabis, or cocaine abuse within two weeks prior to the study\n* have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant\n* certain medications are also exclusionary including aripiprazole.'}, 'identificationModule': {'nctId': 'NCT00937261', 'briefTitle': 'Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning', 'orgStudyIdInfo': {'id': 'BIRN 2008-6382'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risperdal', 'description': 'Risperdal 2-8mg per day', 'interventionNames': ['Drug: Risperidone']}, {'type': 'EXPERIMENTAL', 'label': 'Invega', 'description': 'Invega 6-12mg per day', 'interventionNames': ['Drug: Paliperidone']}], 'interventions': [{'name': 'Risperidone', 'type': 'DRUG', 'otherNames': ['Risperdal'], 'description': '2mg - 8mg per day, for the duration of participation in the study', 'armGroupLabels': ['Risperdal']}, {'name': 'Paliperidone', 'type': 'DRUG', 'otherNames': ['Invega'], 'description': '6mg - 12mg per day, for the duration of participation in the study', 'armGroupLabels': ['Invega']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Steven G Potkin, M.D.', 'role': 'CONTACT', 'email': 'sgpotkin@uci.edu', 'phone': '949-824-8040'}, {'name': 'Liv McMillan, B.S.', 'role': 'CONTACT', 'email': 'liv@uci.edu', 'phone': '949-824-3770'}, {'name': 'Steven G Potkin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'centralContacts': [{'name': 'Liv McMillan, B.S.', 'role': 'CONTACT', 'email': 'liv@uci.edu', 'phone': '949-824-3770'}, {'name': 'Steven G Potkin, M.D.', 'role': 'CONTACT', 'email': 'sgpotkin@uci.edu', 'phone': '714-456-5697'}], 'overallOfficials': [{'name': 'Steven G Potkin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Janssen, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Steven G. Potkin, M.D.', 'oldOrganization': 'UC Irvine -FBIRN'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-06-19', 'type': 'RELEASE'}, {'date': '2013-09-03', 'type': 'RESET'}, {'date': '2017-01-25', 'type': 'RELEASE'}, {'date': '2017-03-14', 'type': 'RESET'}, {'date': '2021-01-20', 'type': 'RELEASE'}, {'date': '2021-01-21', 'type': 'RESET'}, {'date': '2021-05-04', 'type': 'RELEASE'}, {'date': '2021-05-26', 'type': 'RESET'}, {'date': '2021-06-11', 'type': 'RELEASE'}, {'date': '2021-07-01', 'type': 'RESET'}, {'date': '2024-09-16', 'type': 'RELEASE'}, {'date': '2024-10-09', 'type': 'RESET'}, {'date': '2025-01-09', 'type': 'RELEASE'}, {'date': '2025-01-13', 'type': 'RESET'}, {'date': '2025-08-04', 'type': 'RELEASE'}, {'date': '2025-08-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Paramjit Joshi, Professor of Psychiatry & Human Behavior, University of California, Irvine'}}}}