Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-25 @ 7:45 PM
Study NCT ID:
NCT00269035
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2005-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SPECT Study With SB-773812 In Schizophrenic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2007-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-15', 'studyFirstSubmitDate': '2005-12-21', 'studyFirstSubmitQcDate': '2005-12-22', 'lastUpdatePostDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To investigate in schizophrenic patients the relationship between D2 RO, 5HT2A RO and stable plasma concentrations of SB-773812 (gr.1) and the relationship of D2 RO and PK over time at steady state to efficacy readouts after 6 w treatment (gr.2)', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'To assess the effect of 6 week treatment of SB-773812 on clinical symptoms as measured by Positive and Negative Symptoms Scale (PANSS), cognitive performance and CGI Severity and Improvement as a function of duration of dosing (group 2).', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SB-773812', 'SPECT', 'D2 RO', 'pharmacokinetics', 'schizophrenic patients', '5HT2A RO'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gsk-clinicalstudyregister.com/study/773812/007?search=study&search_terms=773812%2F007#rs', 'label': 'Results for study 773812/007 can be found on the GSK Clinical Study Register.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted in 2 groups of schizophrenic patients: in group 1 the relationship between the dopaminergic D2 receptor occupancy (D2 RO ) and serotoninergic 5HT2A receptor occupancy at stable plasma concentration (Cp) of SB-773812 will be investigated using SPECT scan in up to 15 chronic schizophrenic patients in an open- label design. In group 2 up to 80 patients will receive SB-773812 or Risperidone for 6 weeks to obtain at least 10 patients showing clinical improvement with SB-773812. The relationship of D2 RO, measured at steady state after chronic dosing at Cmax (6+/-2 h) and Ctrough (24+/-4 h), and PK at steady state after repeated doses, to efficacy readouts will be investigated. The SB-773812 dose administered will be selected as the highest dose proven to be safe and well tolerated from a previous study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* schizophrenic patients as diagnosed by DSM IV criteria.\n* In group 2, subject has schizophrenia or schizophreniform disorder and show moderate disease exacerbation, a PANSS score \\> 65 and a score in the PANSS positive scale (PANSS-P) =25.\n* Women of childbearing potential must agree to acceptable method of birth control.\n\nExclusion criteria:\n\n* Subject shows severe exacerbation, extreme instability, high risk for suicide or serious violent behaviour.\n* Any clinically or laboratory significant abnormality.\n* Subjects receiving a radiation dose from other activities of more than 10 mSv over any 3 year period.\n* Subjects with organic brain disease and history of severe head trauma.\n* Heart pacemaker, metallic prosthesis or other metallic body implants.\n* Significant head deformity.\n* Smokers with associated COPD.\n* History or presence of clinically significant gastro-intestinal, hepatic or renal disease.\n* History of cholecystectomy or biliary tract disease.\n* Positive for HBV, HCV or HIV.\n* Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT00269035', 'briefTitle': 'SPECT Study With SB-773812 In Schizophrenic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Parallel Study to Investigate Dopaminergic D2 and Serotoninergic 5HT2A Receptor Occupancy at Stable Plasma Concentrations of SB-773812 After Repeated Doses in Schizophrenic Patients. Relationship With Pharmacokinetics and Efficacy Readouts.', 'orgStudyIdInfo': {'id': '773812/007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1', 'description': 'Subjects in group 1 will receive SB-773812 tablet once daily till still steady Cp', 'interventionNames': ['Drug: SB773812']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group 2', 'description': 'Subjects in group 2 will receive SB-773812 tablets once daily over 6 weeks. Risperidone tablets 6 mg once daily from Days 1-7 two tablets of 3 mg and days 8 until stable Cp 6 mg tablets', 'interventionNames': ['Drug: SB773812', 'Drug: Risperidone']}], 'interventions': [{'name': 'SB773812', 'type': 'DRUG', 'description': 'SB-773812 tablets will be available with dose strength of 60 mg', 'armGroupLabels': ['Treatment Group 1', 'Treatment Group 2']}, {'name': 'Risperidone', 'type': 'DRUG', 'description': 'Risperidone tablets will be available with dose strength of 3 and 6 mg', 'armGroupLabels': ['Treatment Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Mataro (Barcelona)', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '08830', 'city': 'Sant Boi de Llobregat', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.34357, 'lon': 2.03659}}, {'zip': '08500', 'city': 'Vic (Barcelona)', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.93012, 'lon': 2.25486}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}