Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT00254202
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2005-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia
Sponsor:
Organization:
Raw JSON
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To provide the most conservative assessment of safety, the 10 patients erroneously randomized twice, who received study drug at each site and met the safety criteria, were counted twice in the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Iloperidone', 'description': 'Oral iloperidone', 'otherNumAtRisk': 300, 'deathsNumAtRisk': 300, 'otherNumAffected': 221, 'seriousNumAtRisk': 300, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Ziprasidone', 'description': 'Oral ziprasidone', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 118, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Oral placebo', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 86, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Microcytic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 300, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 147, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '140', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Iloperidone', 'description': 'Oral iloperidone'}, {'id': 'OG001', 'title': 'Ziprasidone', 'description': 'Oral ziprasidone'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Oral placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.0', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-12.3', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '-7.1', 'spread': '1.48', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': 'The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-to-Treat (ITT) population comprise all randomized patients who receive at least one dose of study medication in the short-term double-blind phase and for whom a baseline PANSS score measurement is obtained and at least one post-baseline PANSS score measurement is obtained while on study medication. For patients randomized in error at a second site after being randomized once, the data from the second site were excluded from analysis in the modified ITT population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Iloperidone', 'description': 'Oral iloperidone'}, {'id': 'FG001', 'title': 'Ziprasidone', 'description': 'Oral ziprasidone'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Oral placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized (excluding randomization errors)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '149'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '98'}, {'groupId': 'FG002', 'numSubjects': '90'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '102'}, {'groupId': 'FG001', 'numSubjects': '51'}, {'groupId': 'FG002', 'numSubjects': '59'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '593', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Iloperidone', 'description': 'Oral iloperidone'}, {'id': 'BG001', 'title': 'Ziprasidone', 'description': 'Oral ziprasidone'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Oral placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '40.7', 'spread': '10.4', 'groupId': 'BG002'}, {'value': '39.9', 'spread': '10.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}, {'value': '472', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '299', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '208', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 593}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2007-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2005-11-10', 'resultsFirstSubmitDate': '2024-04-01', 'studyFirstSubmitQcDate': '2005-11-10', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-11', 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score', 'timeFrame': '4 weeks', 'description': 'The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Atypical antipsychotic', 'Psychosis'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '19573479', 'type': 'DERIVED', 'citation': 'Volpi S, Potkin SG, Malhotra AK, Licamele L, Lavedan C. Applicability of a genetic signature for enhanced iloperidone efficacy in the treatment of schizophrenia. J Clin Psychiatry. 2009 Jun;70(6):801-9. doi: 10.4088/jcp.08m04391.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.', 'detailedDescription': "Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information.\n\nIloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV diagnosis of schizophrenia\n* PANSS-T of at least 70 at screening and baseline\n\nExclusion Criteria:\n\n* Clinically significant disease of the heart, kidneys, liver or gastrointestinal system\n* DSM-IV diagnosis of psychiatric disorder other than schizophrenia'}, 'identificationModule': {'nctId': 'NCT00254202', 'briefTitle': 'Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vanda Pharmaceuticals'}, 'officialTitle': 'A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Iloperidone in Schizophrenic Patients in Acute Exacerbation Followed by a Long-term Treatment Phase.', 'orgStudyIdInfo': {'id': 'VP-VYV-683-3101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Iloperidone', 'description': 'Oral iloperidone', 'interventionNames': ['Drug: Iloperidone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ziprasidone', 'description': 'Oral ziprasidone', 'interventionNames': ['Drug: Ziprasidone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Oral placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Iloperidone', 'type': 'DRUG', 'otherNames': ['Fanapt®', 'VYV-683'], 'armGroupLabels': ['Iloperidone']}, {'name': 'Ziprasidone', 'type': 'DRUG', 'armGroupLabels': ['Ziprasidone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 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