Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 5:12 PM
Study NCT ID:
NCT00397033
Status:
COMPLETED
Last Update Posted:
2013-07-29
First Post:
2006-11-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.
Sponsor:
Organization:
Raw JSON
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'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety Population', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'otherNumAtRisk': 107, 'otherNumAffected': 61, 'seriousNumAtRisk': 107, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day', 'otherNumAtRisk': 108, 'otherNumAffected': 78, 'seriousNumAtRisk': 108, 'seriousNumAffected': 10}, {'id': 'EG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day', 'otherNumAtRisk': 98, 'otherNumAffected': 68, 'seriousNumAtRisk': 98, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 18, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Hypertonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Schizoaffective Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '9.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 98, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Salpingitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Suicidal behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '91.6', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '95.9', 'spread': '13.0', 'groupId': 'OG001'}, {'value': '92.7', 'spread': '12.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat population included all randomized participants who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.', 'testedNonInferiority': False}, {'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is based on the CMH chi-square test with modified ridit scores, stratified by concomitant medication stratum, and country.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': "Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of \\<= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject.", 'unitOfMeasure': 'count of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.'}, {'type': 'SECONDARY', 'title': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.9', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '-9.1', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '-11.3', 'spread': '6.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '-1.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.217', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.', 'unitOfMeasure': 'points on subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population.'}, {'type': 'SECONDARY', 'title': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '-4.2', 'spread': '5.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.108', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-1.0', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.430', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.', 'unitOfMeasure': 'points on a subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population'}, {'type': 'SECONDARY', 'title': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.7', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '-13.9', 'spread': '12.0', 'groupId': 'OG001'}, {'value': '-15.1', 'spread': '10.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '-1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.5', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-2.0', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '0.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum, and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.', 'unitOfMeasure': 'points on a subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population'}, {'type': 'SECONDARY', 'title': 'Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.7', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '-9.6', 'spread': '6.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-2.9', 'ciLowerLimit': '-4.6', 'ciUpperLimit': '-1.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.209', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.', 'unitOfMeasure': 'points on a subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '25.2', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '26.9', 'spread': '7.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with a baseline HAM-D-21 total score of \\>= 16.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.9', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '-13.6', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '-14.5', 'spread': '9.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.6', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-3.8', 'ciLowerLimit': '-6.8', 'ciUpperLimit': '-0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.5', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.', 'unitOfMeasure': 'points on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with a baseline HAM-D-21 total score of \\>= 16.'}, {'type': 'SECONDARY', 'title': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.0', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '-4.0', 'spread': '5.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.232', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.310', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.', 'unitOfMeasure': 'points on a subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population'}, {'type': 'SECONDARY', 'title': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.7', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '-5.7', 'spread': '4.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '-0.6', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.269', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.', 'unitOfMeasure': 'points on a subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population'}, {'type': 'SECONDARY', 'title': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.8', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '-7.0', 'spread': '4.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-2.1', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '-1.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.314', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.', 'unitOfMeasure': 'points on a subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population'}, {'type': 'SECONDARY', 'title': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.4', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '-4.3', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.099', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '0.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.', 'unitOfMeasure': 'points on a subscale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '4.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The CGI-S rating scale is a 7 point global assessment that measures the clinician\'s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects".', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population.'}, {'type': 'SECONDARY', 'title': 'Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '-0.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'The CGI-S rating scale is a 7 point global assessment that measures the clinician\'s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects".', 'unitOfMeasure': 'points on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.'}, {'type': 'PRIMARY', 'title': 'The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.7', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '-27.4', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '-30.6', 'spread': '19.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-8.3', 'ciLowerLimit': '-13.8', 'ciUpperLimit': '-2.9', 'pValueComment': 'The Hochberg step-up procedure was used to address multiplicity.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.8', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'groupDescription': 'One of the primary pairwise comparisons was paliperidone ER high dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.187', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-9.0', 'ciUpperLimit': '1.8', 'pValueComment': 'The Hochberg step-up procedure was used to address multiplicity.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.7', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'groupDescription': 'One of the primary pairwise comparisons was paliperidone ER low dose vs. placebo. The Hochberg step-up procedure was used to address multiplicity. P-value for between treatment group comparisons is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point', 'description': 'The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.', 'unitOfMeasure': 'points on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '2.9', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '1.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher Scores indicate worsening.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.', 'testedNonInferiority': False}, {'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Means Difference', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '0.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANOVA model with fixed-effects for treatment, concomitant medication stratum and country.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Week 6 LOCF End Point', 'description': 'The CGI-C rating scale is a 7 point global assessment that measures the clinician\'s impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to "No change". Ratings of \\<4 are equivalent to "improvement" and ratings of \\> 4 are equivalent to "worsening".', 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '28.5', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '28.4', 'spread': '7.4', 'groupId': 'OG001'}, {'value': '29.9', 'spread': '8.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech \\[rate/amount\\], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.", 'unitOfMeasure': 'points on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with a baseline YMRS total score of \\>= 16.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo'}, {'id': 'OG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'OG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.5', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '-14.3', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '-19.4', 'spread': '11.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-6.8', 'ciLowerLimit': '-9.9', 'ciUpperLimit': '-3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.6', 'estimateComment': 'Paliperidone Extended Release (ER) High Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}, {'pValue': '0.066', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciPctValue': '95', 'paramValue': '-2.8', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '0.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.5', 'estimateComment': 'Paliperidone Extended Release (ER) Low Dose - Placebo on the Change Scores. Higher scores indicate worsening.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from an ANCOVA model with fixed-effects for treatment, concomitant medication stratum and country, and baseline value as a covariate.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': "11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech \\[rate/amount\\], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60.", 'unitOfMeasure': 'points on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with a baseline YMRS total score of \\>= 16.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo'}, {'id': 'FG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'FG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '100'}]}, {'type': 'Safety Population: >= 1 Dose of Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '108'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '105'}, {'groupId': 'FG002', 'numSubjects': '98'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '77'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '310', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo'}, {'id': 'BG001', 'title': 'Paliperidone Extended Release (ER) Low Dose', 'description': 'Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day'}, {'id': 'BG002', 'title': 'Paliperidone Extended Release (ER) High Dose', 'description': 'Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '11.1', 'groupId': 'BG000'}, {'value': '38.1', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '36.5', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '37.3', 'spread': '10.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Intent-to-Treat Population', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intent-to-Treat Population', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Intent-to-Treat Population', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2006-11-07', 'resultsFirstSubmitDate': '2009-03-16', 'studyFirstSubmitQcDate': '2006-11-07', 'lastUpdatePostDateStruct': {'date': '2013-07-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-06-05', 'studyFirstPostDateStruct': {'date': '2006-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16', 'timeFrame': 'Baseline', 'description': 'Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.'}, {'measure': 'Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63.'}, {'measure': 'Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16', 'timeFrame': 'Baseline', 'description': "11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech \\[rate/amount\\], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60."}, {'measure': 'Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': "11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech \\[rate/amount\\], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60."}], 'primaryOutcomes': [{'measure': 'Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score', 'timeFrame': 'Baseline', 'description': 'The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.'}, {'measure': 'The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score.', 'timeFrame': 'Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point', 'description': 'The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Response', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': "Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of \\<= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject."}, {'measure': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening.'}, {'measure': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening.'}, {'measure': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening.'}, {'measure': 'Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening.'}, {'measure': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening.'}, {'measure': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening.'}, {'measure': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening.'}, {'measure': 'Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening.'}, {'measure': 'Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline', 'timeFrame': 'Baseline', 'description': 'The CGI-S rating scale is a 7 point global assessment that measures the clinician\'s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects".'}, {'measure': 'Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder', 'timeFrame': 'Baseline to Week 6 LOCF End Point', 'description': 'The CGI-S rating scale is a 7 point global assessment that measures the clinician\'s impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects".'}, {'measure': 'Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder', 'timeFrame': 'Week 6 LOCF End Point', 'description': 'The CGI-C rating scale is a 7 point global assessment that measures the clinician\'s impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to "No change". Ratings of \\<4 are equivalent to "improvement" and ratings of \\> 4 are equivalent to "worsening".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizoaffective Disorder', 'antipsychotic', 'paliperidone', 'placebo'], 'conditions': ['Schizoaffective Disorder', 'Psychotic Disorder']}, 'referencesModule': {'references': [{'pmid': '26934062', 'type': 'DERIVED', 'citation': 'Alphs L, Fu DJ, Turkoz I. Paliperidone for the treatment of schizoaffective disorder. Expert Opin Pharmacother. 2016;17(6):871-83. doi: 10.1517/14656566.2016.1161029. Epub 2016 Mar 24.'}, {'pmid': '20492853', 'type': 'DERIVED', 'citation': 'Canuso CM, Lindenmayer JP, Kosik-Gonzalez C, Turkoz I, Carothers J, Bossie CA, Schooler NR. A randomized, double-blind, placebo-controlled study of 2 dose ranges of paliperidone extended-release in the treatment of subjects with schizoaffective disorder. J Clin Psychiatry. 2010 May;71(5):587-98. doi: 10.4088/JCP.09m05564yel.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=33&filename=CR010498_CSR.pdf', 'label': 'A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of two dosages of paliperidone ER in the treatment of patients with schizoaffective disorder'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure the effectiveness and assess the safety of two dosages of the antipsychotic paliperidone extended-release (ER) in patients who are experiencing an acute episode of schizoaffective disorder.', 'detailedDescription': "Schizophrenia and schizoaffective disorder are closely related in terms of symptoms, coexisting conditions, and genetic risk. In previous studies in patients with schizophrenia, treatment with paliperidone extended-release (ER) improved psychotic symptoms, as well as mood symptoms evaluated by anxiety/depression and hostility/excitement Positive and Negative Symptoms of Schizophrenia (PANSS) factor scores. Therefore, paliperidone ER may also be effective in treating symptoms of schizoaffective disorder. Paliperidone's limited potential for drug-drug interaction is particularly important in this patient population, in which multiple drug therapy is relatively common. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo-controlled, parallel-group study is designed to examine the effectiveness and safety of paliperidone ER in adult patients with schizoaffective disorder who are experiencing an acute episode of this disorder. Patients in the study will be randomly assigned to 1 of 3 groups to receive 6 weeks of oral treatment with 1 of 2 dosages of paliperidone ER or placebo. The primary efficacy outcome will be the change from baseline to Week 6, or the last post-randomization assessment during double-blind treatment (endpoint), in the PANSS total score. Safety will be assessed by monitoring adverse events, clinical laboratory testing, pregnancy testing, vital signs measurements, physical examination, administration of a 12-lead ECG, movement disorders side effect scales, and the InterSePT Scale for Suicidal Thinking. Patients may also choose to participate in a pharmacogenomic (DNA) analysis. The primary study hypotheses are that at least one of the two dosages of paliperidone ER is better than placebo on the change from baseline in the PANSS total score in acutely ill patients with schizoaffective disorder at the end of 6 weeks of treatment. Patients will receive study drug by mouth for a total of 43 days. Beginning on Day 1, patients will take either placebo or 1 of 2 doses of paliperidone: 6 mg/day (low randomized dosage) or 12 mg/day (high randomized dosage). During the first 2 weeks, dosages may be adjusted."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizoaffective disorder\n* A total Positive and Negative Symptoms of Schizophrenia (PANSS) score of \\>= 60\n* A score of \\>= 16 on Young Mania Rating Scale (YMRS) or a score of \\>= 16 on the Hamilton Depression Rating Scale (HAM-D 21)\n\nExclusion Criteria:\n\n* A primary active mental illness diagnosis other than schizoaffective disorder\n* Patients with first episode psychosis\n* Active substance dependence within previous 6 months\n* Treatment with clozapine within 6 months of randomization\n* A history of treatment resistance, defined by failure to respond to 2 adequate trials of antipsychotic medication\n* Pregnancy, breast-feeding, or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT00397033', 'briefTitle': 'Evaluation of Effectiveness and Safety of Paliperidone Extended Release in Patients With Schizoaffective Disorder.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Two Dosages of Paliperidone ER in the Treatment of Patients With Schizoaffective Disorder.', 'orgStudyIdInfo': {'id': 'CR010498'}, 'secondaryIdInfos': [{'id': 'R076477SCA3001', 'type': 'OTHER', 'domain': 'Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '002', 'description': 'Paliperidone ER 12mg/day paliperidone er for 6 weeks', 'interventionNames': ['Drug: Paliperidone ER']}, {'type': 'EXPERIMENTAL', 'label': '001', 'description': 'Paliperidone ER 6mg/day paliperidone er for 6 weeks', 'interventionNames': ['Drug: Paliperidone ER']}, {'type': 'PLACEBO_COMPARATOR', 'label': '003', 'description': 'Placebo Placebo for 6 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Paliperidone ER', 'type': 'DRUG', 'description': '6mg/day paliperidone er for 6 weeks', 'armGroupLabels': ['001']}, {'name': 'Paliperidone ER', 'type': 'DRUG', 'description': '12mg/day paliperidone er for 6 weeks', 'armGroupLabels': ['002']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for 6 weeks', 'armGroupLabels': ['003']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}