Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT01009060
Status:
COMPLETED
Last Update Posted:
2017-11-08
First Post:
2009-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of GSK239512 in 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': 'C584220', 'term': 'GSK239512'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All SAEs and non-SAEs were reported up to Day 59.', 'description': 'Safety Population were used to report the AEs and serious AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 11, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 μg GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 15, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Middle insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.0606', 'groupId': 'OG000'}, {'value': '0.016', 'spread': '0.1342', 'groupId': 'OG001'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.086', 'spread': '0.0814', 'groupId': 'OG000'}, {'value': '0.104', 'spread': '0.0682', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.076', 'spread': '0.0816', 'groupId': 'OG000'}, {'value': '-0.012', 'spread': '0.1139', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.157', 'spread': '0.0859', 'groupId': 'OG000'}, {'value': '0.068', 'spread': '0.0901', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.099', 'spread': '0.0675', 'groupId': 'OG000'}, {'value': '0.184', 'spread': '0.1057', 'groupId': 'OG001'}]}]}, {'title': 'Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.1234', 'groupId': 'OG000'}, {'value': '0.194', 'spread': '0.1539', 'groupId': 'OG001'}]}]}, {'title': 'Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.004', 'spread': '0.1106', 'groupId': 'OG000'}, {'value': '0.107', 'spread': '0.1105', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7239', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.049', 'ciLowerLimit': '-0.288', 'ciUpperLimit': '0.190', 'groupDescription': 'Week 1', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8351', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.018', 'ciLowerLimit': '-0.127', 'ciUpperLimit': '0.163', 'groupDescription': 'Week 2', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4541', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.088', 'ciLowerLimit': '-0.287', 'ciUpperLimit': '0.110', 'groupDescription': 'Week 3', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4148', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.089', 'ciLowerLimit': '-0.272', 'ciUpperLimit': '0.093', 'groupDescription': 'Week 4', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3887', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.086', 'ciLowerLimit': '-0.082', 'ciUpperLimit': '0.254', 'groupDescription': 'Week 5', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2594', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.195', 'ciLowerLimit': '-0.093', 'ciUpperLimit': '0.484', 'groupDescription': 'Week 6', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4778', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.103', 'ciLowerLimit': '-0.139', 'ciUpperLimit': '0.344', 'groupDescription': 'Week 7', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to Week 7', 'description': 'The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.108', 'spread': '1.8759', 'groupId': 'OG000'}, {'value': '0.371', 'spread': '1.7801', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6947', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.737', 'ciLowerLimit': '-3.884', 'ciUpperLimit': '2.409', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 7', 'description': 'MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and \\< 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the indicated time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'title': 'Speed of Processing/Simple Reaction Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.541', 'spread': '0.1628', 'groupId': 'OG000'}, {'value': '0.289', 'spread': '0.1391', 'groupId': 'OG001'}]}]}, {'title': 'Attention/Vigilance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.067', 'spread': '0.1756', 'groupId': 'OG000'}, {'value': '0.246', 'spread': '0.1932', 'groupId': 'OG001'}]}]}, {'title': 'Working Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.2030', 'groupId': 'OG000'}, {'value': '0.412', 'spread': '0.2164', 'groupId': 'OG001'}]}]}, {'title': 'Visual Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.198', 'spread': '0.2414', 'groupId': 'OG000'}, {'value': '0.081', 'spread': '0.1699', 'groupId': 'OG001'}]}]}, {'title': 'Verbal Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.558', 'spread': '0.2853', 'groupId': 'OG000'}, {'value': '-0.160', 'spread': '0.2339', 'groupId': 'OG001'}]}]}, {'title': 'Reasoning/Problem Solving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.1168', 'groupId': 'OG000'}, {'value': '0.192', 'spread': '0.1085', 'groupId': 'OG001'}]}]}, {'title': 'Social Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.431', 'spread': '0.1544', 'groupId': 'OG000'}, {'value': '-0.401', 'spread': '0.1339', 'groupId': 'OG001'}]}]}, {'title': 'Working Memory (Two-Back Memory)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.247', 'spread': '0.1862', 'groupId': 'OG000'}, {'value': '0.316', 'spread': '0.2374', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1399', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.252', 'ciLowerLimit': '-0.535', 'ciUpperLimit': '0.030', 'estimateComment': 'For Speed of Processing/Simple Reaction Time', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.179', 'ciLowerLimit': '-0.176', 'ciUpperLimit': '0.534', 'estimateComment': 'For Attention/Vigilance', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1547', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.391', 'ciLowerLimit': '-0.063', 'ciUpperLimit': '0.845', 'estimateComment': 'For Working Memory', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2531', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.279', 'ciLowerLimit': '-0.127', 'ciUpperLimit': '0.685', 'estimateComment': 'For Visual Learning', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2417', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.398', 'ciLowerLimit': '-0.167', 'ciUpperLimit': '0.963', 'estimateComment': 'For Verbal Learning', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.2069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.177', 'ciLowerLimit': '-0.055', 'ciUpperLimit': '0.409', 'estimateComment': 'For Reasoning/Problem Solving', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.8645', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.030', 'ciLowerLimit': '-0.262', 'ciUpperLimit': '0.322', 'estimateComment': 'For Social Cognition', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7873', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.069', 'ciLowerLimit': '-0.364', 'ciUpperLimit': '0.503', 'estimateComment': 'For Working Memory (Two-Back Memory)', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 7', 'description': 'The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the specified time points were analyzed. Par. recruited under protocol amendment 2 were not assessed at Weeks 1, 3, 5 or 6 and hence the number of par. at these visits are lower.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'title': 'Speed of Processing', 'categories': [{'measurements': [{'value': '2.045', 'spread': '1.7359', 'groupId': 'OG000'}, {'value': '-1.979', 'spread': '1.6030', 'groupId': 'OG001'}]}]}, {'title': 'Attention/Vigilance', 'categories': [{'measurements': [{'value': '-0.111', 'spread': '2.3028', 'groupId': 'OG000'}, {'value': '-2.351', 'spread': '2.1303', 'groupId': 'OG001'}]}]}, {'title': 'Working Memory', 'categories': [{'measurements': [{'value': '3.368', 'spread': '2.0677', 'groupId': 'OG000'}, {'value': '1.330', 'spread': '1.9086', 'groupId': 'OG001'}]}]}, {'title': 'Visual Learning', 'categories': [{'measurements': [{'value': '-0.718', 'spread': '2.3868', 'groupId': 'OG000'}, {'value': '-1.464', 'spread': '2.2060', 'groupId': 'OG001'}]}]}, {'title': 'Verbal Learning', 'categories': [{'measurements': [{'value': '-1.174', 'spread': '2.1772', 'groupId': 'OG000'}, {'value': '1.938', 'spread': '2.1123', 'groupId': 'OG001'}]}]}, {'title': 'Reasoning and Problem Solving', 'categories': [{'measurements': [{'value': '0.488', 'spread': '2.0863', 'groupId': 'OG000'}, {'value': '1.460', 'spread': '1.9621', 'groupId': 'OG001'}]}]}, {'title': 'Social Cognition', 'categories': [{'measurements': [{'value': '-0.411', 'spread': '3.0119', 'groupId': 'OG000'}, {'value': '-0.750', 'spread': '2.7790', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-4.024', 'ciLowerLimit': '-6.872', 'ciUpperLimit': '-1.175', 'estimateComment': 'For Speed of Processing', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3317', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.240', 'ciLowerLimit': '-6.085', 'ciUpperLimit': '1.605', 'estimateComment': 'For Attention/Vigilance', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.3243', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.038', 'ciLowerLimit': '-5.482', 'ciUpperLimit': '1.406', 'estimateComment': 'For Working Memory', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.7497', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.746', 'ciLowerLimit': '-4.667', 'ciUpperLimit': '3.175', 'estimateComment': 'For Visual Learning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.1585', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.112', 'ciLowerLimit': '-0.537', 'ciUpperLimit': '6.761', 'estimateComment': 'For Verbal Learning', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.6582', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.972', 'ciLowerLimit': '-2.709', 'ciUpperLimit': '4.654', 'estimateComment': 'For Reasoning and Problem Solving', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.9092', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.338', 'ciLowerLimit': '-5.316', 'ciUpperLimit': '4.639', 'estimateComment': 'For Social Cognition', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 7', 'description': 'MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and \\< 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.', 'unitOfMeasure': 'T-scores', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants at indicated time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.795', 'spread': '1.2410', 'groupId': 'OG000'}, {'value': '-3.819', 'spread': '1.1512', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4406', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.024', 'ciLowerLimit': '-3.237', 'ciUpperLimit': '1.190', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 7', 'description': 'BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; lower score is 18 and highest score is 126. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the indicated time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.206', 'spread': '2.4684', 'groupId': 'OG000'}, {'value': '-5.082', 'spread': '2.4087', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.876', 'ciLowerLimit': '-6.743', 'ciUpperLimit': '2.990', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 7', 'description': 'The SANS was a tool used to assess five symptom complexes to obtain clinical ratings of negative symptoms in par. with schizophrenia. Complexes include: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. Assessment was conducted on six-point scale (0=not at all to 5=severe) for a total scoring range of 0-120. Lower scores represent better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the indicated time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.926', 'spread': '2.6007', 'groupId': 'OG000'}, {'value': '4.750', 'spread': '2.3332', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4637', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.824', 'ciLowerLimit': '-2.334', 'ciUpperLimit': '5.982', 'statisticalMethod': 'Mixed Model Repeated Measure', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 7', 'description': 'The UPSA is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains- comprehension and planning, finance, communication, mobility and house management. When combined, measures functional capacity. The comprehension and planning ranges from 0 to 14, the finance ranges from 0 to 11, the communication ranges from 0 to 12, the mobility ranges from 0 to 9, and the house management ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was score at a given time post Baseline minus Baseline score', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only those participants available at the indicated time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 59', 'description': 'AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population consisted of all randomized par. who took at least one dose of investigational product.'}, {'type': 'SECONDARY', 'title': 'Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 59', 'description': 'Triplicate 12-lead ECGs were obtained at Baseline (screening visit). Single 12-lead ECGs were obtained at each subsequent time point during the study. Abnormal ECG findings were presented for the most severe on-treatment result.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants who showed most severe on-treatment abnormal ECG findings are presented.'}, {'type': 'SECONDARY', 'title': 'Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'title': 'SBP, Std, Week 3, <90 or >140 and DFB>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Std, Week 4, <90 or >140 and DFB>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Std, Week 5, <90 or >140 and IFB>=40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Std, Week 5, <90 or >140 and DFB>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Std, Week 6, <90 or >140 and DFB>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Std, follow-up, <90 or >140 and DFB>=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'SBP, Sup, Week 5, <90 or >140 and IFB>=40', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Std, Week 6, <50 or >90 and IBP >=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'DBP, Sup, Week 6, <50 or >90 and IBP >=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 59', 'description': 'Blood pressure readings both systolic and diastolic were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the par. got discharged. Blood pressure was measured in both standing (Std) and supine (Sup) position. Data with only abnormal values were presented. For SBP the data of concern was \\<90 or \\>140 and increase from Baseline (IFB) \\>=40; \\<90 or \\>140 and decrease from Baseline (DFB) \\>=30. For DBP the data of concern was \\<50 or \\>90 and IFB \\>=30; \\<50 or \\>90 and DFB \\>=20.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those par. available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Par. With Heart Rate Measured Value Outside Clinical Concern Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'title': 'Std, Week 5, <50 or >100 and IFB >=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Std, follow-up, <50 or >100 and IFB >=30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 59', 'description': 'Heart rate readings were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the participant got discharged. It was measured in both supine and standing position. For both Std and Sup positions, heart rate data of concern was \\<50 or \\>100 and IFB \\>=30; \\<50 or \\>100 and DFB \\>=30. Data with only abnormal values were presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those par. available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Par. With Abnormal Hematology Parameters Values at Any Time on Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'title': 'Eosinophils, Low', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils, High', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin, Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes, Low', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'RBC count, Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Reticulocytes, Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils count, Low', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 59', 'description': 'Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Hemoglobin concentration (MCHC), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red blood cell count (RBC), Reticulocytes, Neutrophils count and White blood cell (WBC) count were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those par. available at the indicated time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Par. With Abnormal Clinical Chemistry Parameters Values at Any Time On-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'title': 'ALT, High', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'AST, High', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'GGT, High', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, Low', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Glucose, High', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 59', 'description': 'Clinical chemistry parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Creatinine, Direct Bilirubin, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Sodium, Total Bilirubin, Total protein, Urea/ Blood urea nitrogen (BUN) were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those par. available at the indicated time point were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'OG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 59', 'description': 'Samples for urinalysis were collected on Days 1, 7, 14, 21, 28, 35, 42, 49 and up to Day 59 (follow-up) to assess specific gravity, pH, glucose, protein, blood and ketone by dipstick and microscopic examination (if blood or protein is abnormal).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentrations of GSK239512 (Cmax) at Steady State After Repeat Dosing on Dose Review Visit at Any Time On-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}, {'units': 'Plasma sample', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GSK239512 10 mcg', 'description': 'Par. received GSK239512 10 mcg daily as dose level 1 in the first week of study.'}, {'id': 'OG001', 'title': 'GSK239512 20 mcg', 'description': 'Par. received GSK239512 20 mcg daily as dose level 2 in the second week of study.'}, {'id': 'OG002', 'title': 'GSK239512 40 mcg', 'description': 'Par. received GSK239512 40 mcg daily as dose level 3 in the third week of study.'}, {'id': 'OG003', 'title': 'GSK239512 80 mcg', 'description': 'Par. received GSK239512 80 mcg daily as dose level 4 in the fourth week of study and continued to receive from fifth to seventh week as maintenance phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0250', 'spread': '37.44', 'groupId': 'OG000'}, {'value': '0.0496', 'spread': '29.84', 'groupId': 'OG001'}, {'value': '0.0790', 'spread': '51.85', 'groupId': 'OG002'}, {'value': '0.1775', 'spread': '42.91', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '15 minutes prior to start and 15 minutes after completion of CSSB at Week 1,2,3,4,5,6 and 7', 'description': "One Pharmacokinetic (PK) sample was collected within 15 minutes prior to the start of the CSSB and one PK sample was collected within 15 minutes after completion of the CSSB. 'n' was the number of samples available for analysis.", 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Plasma sample', 'denomUnitsSelected': 'Plasma sample', 'populationDescription': 'PK-concentration population included all par. for whom a PK sample was obtained and analyzed. Number of units analyzed are number of samples available for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'FG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 14 centers in the United States from 1 December 2009 to 10 August 2011. Study included d-amphetamine therapeutic challenge (dropped in amendment 2), treatment period of 7 weeks (4 weeks titration and 3 weeks of maintenance) and follow up visit approximately 7-10 days following their last dose of study medication.', 'preAssignmentDetails': 'A total of 118 participants (par.) were screened. Out of these 50 participants were randomized. Out of these, safety population consisted of 50 participants and intent-to-treat (ITT) population consisted of 46 participants.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Par. received oral placebo tablet matching with GSK239512 once daily for a period of 7 weeks.'}, {'id': 'BG001', 'title': 'GSK239512', 'description': 'Par. received oral GSK239512 once daily for a period of 7 weeks (4 weeks titration and 3 weeks at maintenance). Par. started at a daily dose of 10 micrograms (μg) GSK239512 and titrated up weekly through successive dose levels of 20 μg, 40 μg up to a maximum dose of 80 μg according to the titration regimen.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '9.54', 'groupId': 'BG000'}, {'value': '38.2', 'spread': '13.10', 'groupId': 'BG001'}, {'value': '39.2', 'spread': '11.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Number'}], 'populationDescription': 'Baseline characteristic data is presented for ITT population which consisted of all participants randomized to treatment, who had taken at least one dose of investigational product and who had at least one post-Baseline CogState Schizophrenia Battery (CSSB) assessment during the on-treatment phase.'}}, '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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2012-03-15', 'completionDateStruct': {'date': '2011-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2009-11-05', 'dispFirstSubmitQcDate': '2012-03-15', 'resultsFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2009-11-05', 'dispFirstPostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-29', 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Composite Score of CSSB Following Dosing With GSK239512', 'timeFrame': 'Baseline and up to Week 7', 'description': 'The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) at Week 7', 'timeFrame': 'Baseline and Week 7', 'description': 'MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and \\< 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.'}, {'measure': 'Change From Baseline in Individual Cognitive Domain Scores in CSSB at Week 7', 'timeFrame': 'Baseline and Week 7', 'description': 'The CSSB is a computerized battery with following domains (score range): Verbal memory (0-75), working memory (0-28), motor speed (0-100), verbal fluency, attention and speed of information processing (0-110) and executive functions with higher score representing better performance. Two Baseline CSSB testing were conducted; the first on the day prior to commencing dosing (Day -1) and the other test pre-dose on Day 1: the average of the two tests was used as Baseline. Change from Baseline was calculated as score at a given time minus score at Baseline. For each individual task from the CSSB, the Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. A composite score was calculated by averaging all the measures, and then calculating a z-score of the composite. Higher the composite score, better is the performance. Z-score is the measure of standard deviation away from the mean score.'}, {'measure': 'Change From Baseline in Individual Cognitive Domain Scores in MCCB at Week 7', 'timeFrame': 'Baseline and Week 7', 'description': 'MCCB measures functioning across various cognitive domains and is comprised of ten tests that assess seven cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition) Its measurements are based on timed paper-and-pencil, computerized, and orally-administered tests, as well as spatial tests using geometric cubes. MCCB composite T scores are between 40 and 60 (normal range) and \\< 40 (below normal range). Higher scores indicate better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.'}, {'measure': 'Change From Baseline in Brief Psychiatric Rating Scale (BPRS) at Week 7', 'timeFrame': 'Baseline and Week 7', 'description': 'BPRS is the clinician rating of psychiatric symptoms; higher score indicates higher severity; 18-items scored 1-7; lower score is 18 and highest score is 126. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.'}, {'measure': 'Change From Baseline in Schedule for Assessment of Negative Symptoms (SANS) at Week 7', 'timeFrame': 'Baseline and Week 7', 'description': 'The SANS was a tool used to assess five symptom complexes to obtain clinical ratings of negative symptoms in par. with schizophrenia. Complexes include: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. Assessment was conducted on six-point scale (0=not at all to 5=severe) for a total scoring range of 0-120. Lower scores represent better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either measurement meant to be used in the mean was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was calculated as score at a given time post Baseline minus score at Baseline.'}, {'measure': 'Change From Baseline in University of California and San Diego (UCSD) Performance Based Skills Assessment (UPSA) at Week 7', 'timeFrame': 'Baseline and Week 7', 'description': 'The UPSA is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains- comprehension and planning, finance, communication, mobility and house management. When combined, measures functional capacity. The comprehension and planning ranges from 0 to 14, the finance ranges from 0 to 11, the communication ranges from 0 to 12, the mobility ranges from 0 to 9, and the house management ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance. The Baseline was calculated as the mean of the second screening assessment and the Day 1 pre-dose assessment. If either was missing, then the Baseline value was the non-missing assessment. If both were missing, then Baseline was considered missing and the task was excluded from the analysis. Change from Baseline was score at a given time post Baseline minus Baseline score'}, {'measure': 'Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Day 59', 'description': 'AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.'}, {'measure': 'Number of Par. With Most Severe On-treatment Abnormal Electrocardiogram (ECG) Findings', 'timeFrame': 'Up to Day 59', 'description': 'Triplicate 12-lead ECGs were obtained at Baseline (screening visit). Single 12-lead ECGs were obtained at each subsequent time point during the study. Abnormal ECG findings were presented for the most severe on-treatment result.'}, {'measure': 'Number of Par. With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Readings Outside Clinical Concern Range', 'timeFrame': 'Up to Day 59', 'description': 'Blood pressure readings both systolic and diastolic were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the par. got discharged. Blood pressure was measured in both standing (Std) and supine (Sup) position. Data with only abnormal values were presented. For SBP the data of concern was \\<90 or \\>140 and increase from Baseline (IFB) \\>=40; \\<90 or \\>140 and decrease from Baseline (DFB) \\>=30. For DBP the data of concern was \\<50 or \\>90 and IFB \\>=30; \\<50 or \\>90 and DFB \\>=20.'}, {'measure': 'Number of Par. With Heart Rate Measured Value Outside Clinical Concern Range', 'timeFrame': 'Up to Day 59', 'description': 'Heart rate readings were collected at pre-dose and then hourly post-dose until 6 hours post-dose or until the participant got discharged. It was measured in both supine and standing position. For both Std and Sup positions, heart rate data of concern was \\<50 or \\>100 and IFB \\>=30; \\<50 or \\>100 and DFB \\>=30. Data with only abnormal values were presented.'}, {'measure': 'Number of Par. With Abnormal Hematology Parameters Values at Any Time on Treatment', 'timeFrame': 'Up to Day 59', 'description': 'Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Hemoglobin concentration (MCHC), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red blood cell count (RBC), Reticulocytes, Neutrophils count and White blood cell (WBC) count were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.'}, {'measure': 'Number of Par. With Abnormal Clinical Chemistry Parameters Values at Any Time On-treatment', 'timeFrame': 'Up to Day 59', 'description': 'Clinical chemistry parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase, Aspartate Amino Transferase (AST), Calcium, Creatinine, Direct Bilirubin, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Sodium, Total Bilirubin, Total protein, Urea/ Blood urea nitrogen (BUN) were presented as values of potential clinical concern at any time on treatment. Only those parameters with any abnormal value are presented.'}, {'measure': 'Number of Par. With Abnormal Urinalysis Parameters Values of Potential Clinical Concern', 'timeFrame': 'Up to Day 59', 'description': 'Samples for urinalysis were collected on Days 1, 7, 14, 21, 28, 35, 42, 49 and up to Day 59 (follow-up) to assess specific gravity, pH, glucose, protein, blood and ketone by dipstick and microscopic examination (if blood or protein is abnormal).'}, {'measure': 'Plasma Concentrations of GSK239512 (Cmax) at Steady State After Repeat Dosing on Dose Review Visit at Any Time On-treatment', 'timeFrame': '15 minutes prior to start and 15 minutes after completion of CSSB at Week 1,2,3,4,5,6 and 7', 'description': "One Pharmacokinetic (PK) sample was collected within 15 minutes prior to the start of the CSSB and one PK sample was collected within 15 minutes after completion of the CSSB. 'n' was the number of samples available for analysis."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['H3 Antagonist', 'Schizophrenia', 'double blind', 'Histamine', 'randomised', 'placebo controlled', 'Cognition'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'availIpds': [{'id': '113147', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113147', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113147', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113147', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113147', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113147', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '113147', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'pmid': '25728831', 'type': 'DERIVED', 'citation': 'Jarskog LF, Lowy MT, Grove RA, Keefe RS, Horrigan JP, Ball MP, Breier A, Buchanan RW, Carter CS, Csernansky JG, Goff DC, Green MF, Kantrowitz JT, Keshavan MS, Laurelle M, Lieberman JA, Marder SR, Maruff P, McMahon RP, Seidman LJ, Peykamian MA. A Phase II study of a histamine H(3) receptor antagonist GSK239512 for cognitive impairment in stable schizophrenia subjects on antipsychotic therapy. Schizophr Res. 2015 May;164(1-3):136-42. doi: 10.1016/j.schres.2015.01.041. Epub 2015 Feb 24.'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with schizophrenia', 'detailedDescription': 'This is a 7-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group design study in male and female subjects with schizophrenia who are stabilised on antipsychotic medication. Subjects will be randomised to receive either GSK239512 or placebo for 7 weeks. They will undergo weekly review of safety, tolerability and cognitive performance measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of Schizophrenia\n2. No acute exacerbation of symptoms requiring hospital admission or step up care in the previous six months.\n3. Not on any symptomatic treatment for cognition\n\nExclusion Criteria:\n\n1. Poses a significant homicidal or suicidal risk or evidence of previous homicidal or suicidal risk.\n2. Co-morbid psychiatric or significant physical illness\n3. Alcohol or drug abuse or dependence.'}, 'identificationModule': {'nctId': 'NCT01009060', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of GSK239512 in Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomised Double-blind, Placebo Controlled, Parallel Group Study to Evaluate the Cognitive Enhancing Effect of GSK239512 in Stable Patients With Schizophrenia', 'orgStudyIdInfo': {'id': '113147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GSK239512', 'description': 'Repeat dose.', 'interventionNames': ['Drug: GSK239512']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Repeat dose. Placebo to match GSK239512', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GSK239512', 'type': 'DRUG', 'description': 'Histamine H3 Antagonist', 'armGroupLabels': ['GSK239512']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match GSK239512', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92102', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46222', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21228', 'city': 'Catonsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.27205, 'lon': -76.73192}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02130', 'city': 'Jamaica Plain', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.30982, 'lon': -71.12033}}, {'zip': '08054', 'city': 'Mount Laurel', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.934, 'lon': -74.891}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27509', 'city': 'Butner', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.13209, 'lon': -78.75667}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}