Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-31 @ 9:00 PM
Study NCT ID:
NCT00921804
Status:
COMPLETED
Last Update Posted:
2010-06-30
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2020-08-18', 'unreleaseDate': '2020-08-25'}], 'estimatedResultsFirstSubmitDate': '2020-08-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D006212', 'term': 'Hallucinations'}, {'id': 'D010259', 'term': 'Paranoid Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-29', 'studyFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PANSS Total Score', 'timeFrame': 'Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28'}], 'secondaryOutcomes': [{'measure': 'PANSS Positive, Negative, and General Psychopathology Subscale Scores', 'timeFrame': 'Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28'}, {'measure': 'CGI-S', 'timeFrame': 'Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28'}, {'measure': 'Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events', 'timeFrame': 'Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28'}]}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Hallucinations', 'Paranoia', 'Inpatient schizophrenia clinical trial'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient will need to read, understand and sign an informed consent prior to any study specific procedures\n* Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry\n\nExclusion Criteria:\n\n* Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies)\n* Patients will be excluded if urine drug screen test show positive results\n* Smoking of more than 2 packs of cigarettes a day'}, 'identificationModule': {'nctId': 'NCT00921804', 'briefTitle': 'Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Active-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD8529 in Adult Schizophrenia Patients', 'orgStudyIdInfo': {'id': 'D1960C00004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD8529 40 mg', 'interventionNames': ['Drug: AZD 8529', 'Drug: Placebo to match risperidone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo to match AZD8529', 'Drug: Placebo to match risperidone']}, {'type': 'OTHER', 'label': '3', 'description': 'Risperidone 4 mg (2mg on Day 1)', 'interventionNames': ['Drug: Risperidone', 'Drug: Placebo to match AZD8529']}], 'interventions': [{'name': 'AZD 8529', 'type': 'DRUG', 'description': '40mg oral daily capsule administered as a single dose in the morning for 28 days', 'armGroupLabels': ['1']}, {'name': 'Risperidone', 'type': 'DRUG', 'otherNames': ['Risperdal'], 'description': '4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days', 'armGroupLabels': ['3']}, {'name': 'Placebo to match AZD8529', 'type': 'DRUG', 'description': 'Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period', 'armGroupLabels': ['2', '3']}, {'name': 'Placebo to match risperidone', 'type': 'DRUG', 'description': 'Placebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'Robert, Litman, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850'}, {'name': 'Mark Smith', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca1800 Concord PikeWilmington, DE, 19850'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MSD', 'oldOrganization': 'AstraZeneca'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-18', 'type': 'RELEASE'}, {'date': '2020-08-25', 'type': 'UNRELEASE'}], 'unpostedResponsibleParty': 'AstraZeneca'}}}}