Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-31 @ 3:47 AM
Study NCT ID:
NCT00669903
Status:
TERMINATED
Last Update Posted:
2010-08-06
First Post:
2008-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'C543642', 'term': "spiro(1-azabicyclo(2.2.2)octane-3,2'(3H)-furo(2,3-b)pyridine)"}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'No publication or presentation of results until the earlier of the publication of the first multi-center publication and the second anniversary of the completion of the multi-center study at all sites. Sponsor must receive a copy of proposed manuscript for review and comment at least 60 days prior to its submission for publication or presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)', 'otherNumAtRisk': 23, 'otherNumAffected': 17, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)', 'otherNumAtRisk': 37, 'otherNumAffected': 22, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)', 'otherNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 22, 'otherNumAffected': 11, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'LETHARGY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'SEDATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'TOOTHACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'seriousEvents': [{'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)'}, {'id': 'OG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)'}, {'id': 'OG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.234', 'spread': '0.122', 'groupId': 'OG000', 'lowerLimit': '0.122'}, {'value': '0.240', 'spread': '0.072', 'groupId': 'OG001', 'lowerLimit': '0.072'}, {'value': '0.194', 'spread': '0.216', 'groupId': 'OG002', 'lowerLimit': '0.216'}, {'value': '0.266', 'spread': '0.099', 'groupId': 'OG003', 'lowerLimit': '0.099'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)'}, {'id': 'OG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)'}, {'id': 'OG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.313', 'spread': '0.163', 'groupId': 'OG000', 'lowerLimit': '0.163'}, {'value': '0.360', 'spread': '0.104', 'groupId': 'OG001', 'lowerLimit': '0.104'}, {'value': '0.281', 'spread': '0.249', 'groupId': 'OG002', 'lowerLimit': '0.249'}, {'value': '0.235', 'spread': '0.124', 'groupId': 'OG003', 'lowerLimit': '0.124'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'GMLT score is defined as the -log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)'}, {'id': 'OG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)'}, {'id': 'OG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.150', 'spread': '0.126', 'groupId': 'OG000', 'lowerLimit': '0.126'}, {'value': '0.102', 'spread': '0.100', 'groupId': 'OG001', 'lowerLimit': '0.100'}, {'value': '0.094', 'spread': '0.232', 'groupId': 'OG002', 'lowerLimit': '0.232'}, {'value': '0.316', 'spread': '0.152', 'groupId': 'OG003', 'lowerLimit': '0.152'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CogState Detection Task (DT) Standardized Change Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)'}, {'id': 'OG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)'}, {'id': 'OG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.116', 'spread': '0.116', 'groupId': 'OG000', 'lowerLimit': '0.116'}, {'value': '-0.014', 'spread': '0.115', 'groupId': 'OG001', 'lowerLimit': '0.115'}, {'value': '-0.095', 'spread': '0.158', 'groupId': 'OG002', 'lowerLimit': '0.158'}, {'value': '0.098', 'spread': '0.095', 'groupId': 'OG003', 'lowerLimit': '0.095'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CogState Identification Task (IT) Standardized Change Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)'}, {'id': 'OG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)'}, {'id': 'OG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.145', 'spread': '0.177', 'groupId': 'OG000', 'lowerLimit': '0.177'}, {'value': '-0.049', 'spread': '0.121', 'groupId': 'OG001', 'lowerLimit': '0.121'}, {'value': '-0.173', 'spread': '0.136', 'groupId': 'OG002', 'lowerLimit': '0.136'}, {'value': '-0.103', 'spread': '0.132', 'groupId': 'OG003', 'lowerLimit': '0.132'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)'}, {'id': 'OG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)'}, {'id': 'OG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.213', 'spread': '0.139', 'groupId': 'OG000', 'lowerLimit': '0.139'}, {'value': '0.406', 'spread': '0.112', 'groupId': 'OG001', 'lowerLimit': '0.112'}, {'value': '0.467', 'spread': '0.263', 'groupId': 'OG002', 'lowerLimit': '0.263'}, {'value': '0.409', 'spread': '0.183', 'groupId': 'OG003', 'lowerLimit': '0.183'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'GMRT score defined as the -log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate', 'unitOfMeasure': 'unit on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)'}, {'id': 'FG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)'}, {'id': 'FG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'Completed Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of two US centers were inititated with first patient enrolled on 2 April 2008 and last patient completed on 4 November 2008. A total of 158 patients were enrolled with 100 patients allocated to randomized treatment.', 'preAssignmentDetails': 'Patients were to receive a stable dose of an antipsychotic for the 4 weeks prior to randomization, have stable psychotic symptoms without a hospitalization for the 8 weeks prior to randomization, and were to be smoking an average of \\>=10 cigarettes per day. Enrolled patients who no longer met entry criteria at randomization were not randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '100', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD0328 Low Dose Group', 'description': 'AZD0328 Low dose group (0.00093 to 0.0028 mg oral solution)'}, {'id': 'BG001', 'title': 'AZD0328 Optimal Dose Group', 'description': 'AZD0328 Optimal dose group (0.0048 to 0.0329 mg oral solution)'}, {'id': 'BG002', 'title': 'AZD0328 High Dose Group', 'description': 'AZD0328 High dose group (0.075 to 0.675 mg oral solution)'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '41.7', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '40.0', 'spread': '9.8', 'groupId': 'BG003'}, {'value': '40.0', 'spread': '9.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '86', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Positive and Negative Syndrome Scale (PANSS) total score', 'classes': [{'categories': [{'measurements': [{'value': '67.9', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '72.1', 'spread': '12.2', 'groupId': 'BG002'}, {'value': '69.5', 'spread': '13.2', 'groupId': 'BG003'}, {'value': '70.4', 'spread': '11.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline Positive and Negative Syndrome Scale (PANSS) total score. Best value for PANSS total score = 30 to worse value for PANSS total score = 210', 'unitOfMeasure': 'Points of PANSS score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'Since AZD0328 is unlikely to meet the current Target Product Profile, Astrazeneca decided to stop further development of AZD0328', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-09', 'studyFirstSubmitDate': '2008-04-29', 'resultsFirstSubmitDate': '2010-02-04', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-07-09', 'studyFirstPostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).'}], 'secondaryOutcomes': [{'measure': 'CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'GMLT score is defined as the -log10 transform of the sum of the number of errors made during GMLT trials. Mean GMLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMLT standardized change score was calculated as the change from baseline in the mean GMLT score divided by the within subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).'}, {'measure': 'CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'OCLT score is defined as the arcsine transform of the proportion of correct responses during OCLT trials. Mean OCLT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The OCLT standardized change score was calculated as the change from baseline in the mean OCLT score divided by the within-subject standard deviation. Scale range from negative infinity (worst value) to positive infinity (best value).'}, {'measure': 'CogState Detection Task (DT) Standardized Change Score at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'DT score is defined as -1 times the mean of log10 transformed reaction times for all correct responses. Mean DT score was calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The DT standardized change score will be calculated as the change from baseline in the mean DT score divided by the within-subject standard deviation. Score range from negative infinity (worst value) to positive infinity (best value).'}, {'measure': 'CogState Identification Task (IT) Standardized Change Score at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'IT score defined as 1 times the mean of log10 transformed reaction times for all correct responses. Mean IT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The IT standardized change score will be calculated as the change from baseline in the mean IT score divided by the within-subject standard dev. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate'}, {'measure': 'CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14', 'timeFrame': 'Baseline and Day 14', 'description': 'GMRT score defined as the -log10 transform of the sum of the number of errors made during GMRT trials. Mean GMRT score calculated as the average of the 2 hour, 5 hour, and 8 hour scores. The GMRT standardized change score was calculated as change from baseline in mean GMRT score divided by the within subject standard deviation. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, assessment day-by-treatment interaction as fixed factors, center as random factor, and baseline score as a covariate'}]}, 'conditionsModule': {'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of schizophrenia according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)\n* Low level of Extra-pyramidal symptoms\n* No clinically significant findings on physical examination\n\nExclusion Criteria:\n\n* Diagnosis of schizoaffective or schizophreniform disorders\n* Any significant psychiatric or neurological disease other than schizophrenia'}, 'identificationModule': {'nctId': 'NCT00669903', 'briefTitle': 'Study to Asses Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of AZD0328 in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Oral Multiple Ascending Doses of AZD0328 in Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'D0190C00007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD0328 low dose', 'interventionNames': ['Drug: AZD0328']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'AZD0328 Optimal dose', 'interventionNames': ['Drug: AZD0328']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'AZD0328 High dose', 'interventionNames': ['Drug: AZD0328']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'Placebo Comparator', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD0328', 'type': 'DRUG', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Didier Meulien - Medical Science Director', 'oldOrganization': 'AstraZeneca'}}}}