Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-01 @ 9:44 AM
Study NCT ID:
NCT04512066
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '1-800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks for double-blind treatment period Up to 48 weeks for extension period', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 23, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'RO6889450 45 mg (Double-blind Treatment Period)', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 14, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'RO6889450 150 mg (Double-blind Treatment Period)', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 23, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Risperidone 4 mg (Double-blind Treatment Period)', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 36, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo - RO6889450 45 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg once daily (QD) of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 5, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Placebo - RO6889450 150 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 6, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'RO6889450 45 mg (Extension Period)', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 7, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'RO6889450 150 mg (Extension Period)', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 12, 'seriousNumAtRisk': 45, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG008', 'title': 'Risperidone 4 mg (Extension Period)', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 5, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'seriousEvents': [{'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}, {'term': 'Gun shot wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 41, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 53, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG002', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.38', 'spread': '11.36', 'groupId': 'OG000'}, {'value': '98.54', 'spread': '9.51', 'groupId': 'OG001'}, {'value': '100.53', 'spread': '12.25', 'groupId': 'OG002'}, {'value': '100.03', 'spread': '10.56', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.69', 'spread': '20.18', 'groupId': 'OG000'}, {'value': '88.94', 'spread': '17.03', 'groupId': 'OG001'}, {'value': '85.18', 'spread': '17.67', 'groupId': 'OG002'}, {'value': '78.04', 'spread': '15.78', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.849', 'groupIds': ['OG000', 'OG001'], 'paramType': 'treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.60', 'ciLowerLimit': '-4.58', 'ciUpperLimit': '5.78', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.362', 'groupIds': ['OG000', 'OG002'], 'paramType': 'treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-2.83', 'ciLowerLimit': '-7.96', 'ciUpperLimit': '2.29', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'treatment effect', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-10.45', 'ciLowerLimit': '-15.46', 'ciUpperLimit': '-5.43', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 (Day 28)', 'description': 'The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS Factor Scores at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG002', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Anxiety/Depression - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.58', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '12.91', 'spread': '2.92', 'groupId': 'OG001'}, {'value': '11.54', 'spread': '3.40', 'groupId': 'OG002'}, {'value': '12.58', 'spread': '3.67', 'groupId': 'OG003'}]}]}, {'title': 'Anxiety/Depression - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.56', 'spread': '4.03', 'groupId': 'OG000'}, {'value': '9.88', 'spread': '4.15', 'groupId': 'OG001'}, {'value': '9.06', 'spread': '4.08', 'groupId': 'OG002'}, {'value': '8.50', 'spread': '4.09', 'groupId': 'OG003'}]}]}, {'title': 'Avolition - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.99', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '15.86', 'spread': '2.83', 'groupId': 'OG001'}, {'value': '16.38', 'spread': '3.25', 'groupId': 'OG002'}, {'value': '16.20', 'spread': '2.73', 'groupId': 'OG003'}]}]}, {'title': 'Avolition - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.04', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '13.67', 'spread': '4.42', 'groupId': 'OG001'}, {'value': '13.73', 'spread': '3.69', 'groupId': 'OG002'}, {'value': '12.93', 'spread': '3.44', 'groupId': 'OG003'}]}]}, {'title': 'Disorganized thought/Cognition - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.86', 'spread': '4.43', 'groupId': 'OG000'}, {'value': '21.43', 'spread': '4.66', 'groupId': 'OG001'}, {'value': '22.50', 'spread': '4.82', 'groupId': 'OG002'}, {'value': '21.45', 'spread': '4.87', 'groupId': 'OG003'}]}]}, {'title': 'Disorganized thought/Cognition - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.69', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '20.63', 'spread': '4.94', 'groupId': 'OG001'}, {'value': '19.41', 'spread': '6.44', 'groupId': 'OG002'}, {'value': '17.07', 'spread': '4.66', 'groupId': 'OG003'}]}]}, {'title': 'Expressive deficit - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.89', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '10.31', 'spread': '3.96', 'groupId': 'OG001'}, {'value': '10.90', 'spread': '3.79', 'groupId': 'OG002'}, {'value': '10.23', 'spread': '3.43', 'groupId': 'OG003'}]}]}, {'title': 'Expressive deficit - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.81', 'spread': '4.01', 'groupId': 'OG000'}, {'value': '10.69', 'spread': '4.39', 'groupId': 'OG001'}, {'value': '10.16', 'spread': '4.18', 'groupId': 'OG002'}, {'value': '10.71', 'spread': '3.67', 'groupId': 'OG003'}]}]}, {'title': 'Totals general - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48.42', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '48.69', 'spread': '5.49', 'groupId': 'OG001'}, {'value': '48.68', 'spread': '6.57', 'groupId': 'OG002'}, {'value': '48.89', 'spread': '6.29', 'groupId': 'OG003'}]}]}, {'title': 'Totals general - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42.43', 'spread': '10.68', 'groupId': 'OG000'}, {'value': '43.71', 'spread': '9.06', 'groupId': 'OG001'}, {'value': '40.43', 'spread': '8.94', 'groupId': 'OG002'}, {'value': '37.07', 'spread': '8.12', 'groupId': 'OG003'}]}]}, {'title': 'Negative symptom factor score - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.58', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '23.02', 'spread': '5.19', 'groupId': 'OG001'}, {'value': '23.81', 'spread': '5.36', 'groupId': 'OG002'}, {'value': '23.34', 'spread': '4.55', 'groupId': 'OG003'}]}]}, {'title': 'Negative symptom factor score - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.63', 'spread': '6.04', 'groupId': 'OG000'}, {'value': '21.27', 'spread': '6.63', 'groupId': 'OG001'}, {'value': '20.80', 'spread': '5.70', 'groupId': 'OG002'}, {'value': '20.39', 'spread': '5.55', 'groupId': 'OG003'}]}]}, {'title': 'Totals negative - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24.10', 'spread': '5.29', 'groupId': 'OG000'}, {'value': '23.65', 'spread': '4.50', 'groupId': 'OG001'}, {'value': '24.59', 'spread': '4.87', 'groupId': 'OG002'}, {'value': '23.65', 'spread': '3.78', 'groupId': 'OG003'}]}]}, {'title': 'Totals negative - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.65', 'spread': '5.81', 'groupId': 'OG000'}, {'value': '21.82', 'spread': '5.85', 'groupId': 'OG001'}, {'value': '22.53', 'spread': '5.41', 'groupId': 'OG002'}, {'value': '21.45', 'spread': '5.13', 'groupId': 'OG003'}]}]}, {'title': 'Positive symptom factor score - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '31.40', 'spread': '3.59', 'groupId': 'OG000'}, {'value': '30.66', 'spread': '3.84', 'groupId': 'OG001'}, {'value': '32.03', 'spread': '4.89', 'groupId': 'OG002'}, {'value': '31.15', 'spread': '3.73', 'groupId': 'OG003'}]}]}, {'title': 'Positive symptom factor score - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '27.72', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '28.06', 'spread': '6.14', 'groupId': 'OG001'}, {'value': '26.63', 'spread': '7.16', 'groupId': 'OG002'}, {'value': '24.21', 'spread': '5.38', 'groupId': 'OG003'}]}]}, {'title': 'Totals positive - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.86', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '26.20', 'spread': '4.19', 'groupId': 'OG001'}, {'value': '27.26', 'spread': '5.13', 'groupId': 'OG002'}, {'value': '27.49', 'spread': '3.95', 'groupId': 'OG003'}]}]}, {'title': 'Totals positive - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.61', 'spread': '6.64', 'groupId': 'OG000'}, {'value': '23.41', 'spread': '6.14', 'groupId': 'OG001'}, {'value': '22.22', 'spread': '6.50', 'groupId': 'OG002'}, {'value': '19.52', 'spread': '5.11', 'groupId': 'OG003'}]}]}, {'title': 'Uncontrolled hostility/excitement - Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.94', 'spread': '3.94', 'groupId': 'OG000'}, {'value': '10.52', 'spread': '4.07', 'groupId': 'OG001'}, {'value': '10.65', 'spread': '4.12', 'groupId': 'OG002'}, {'value': '11.51', 'spread': '3.90', 'groupId': 'OG003'}]}]}, {'title': 'Uncontrolled hostility/excitement - Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.09', 'spread': '4.83', 'groupId': 'OG000'}, {'value': '9.10', 'spread': '4.33', 'groupId': 'OG001'}, {'value': '9.27', 'spread': '4.22', 'groupId': 'OG002'}, {'value': '7.86', 'spread': '4.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 (Day 28)', 'description': 'PANSS factors are modified groupings of the 30 PANSS items from the original three subscales (positive, negative, and general psychopathology). Each item is rated on a scale of 1 (absent) to 7 (most extreme). The positive symptom factor contains 8 items (score range 8-56); the negative symptom and disorganized thought/cognition factors contain 7 items (score range 7-49); the uncontrolled hostility/excitement, expressive deficit, and anxiety/depression factors contain 4 items (score range 4-28); and the avolition domain contains 3 items (score range 3-21). The negative and positive totals each have a range of 7-49 and the general total has a range of 16-112. Higher scores indicate higher symptom severity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With at Least 20% or 50% Improvement From Baseline in the PANSS Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG002', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': '20% improvement - Week 1', 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}, {'value': '26.2', 'groupId': 'OG001'}, {'value': '27.9', 'groupId': 'OG002'}, {'value': '25.4', 'groupId': 'OG003'}]}]}, {'title': '20% improvement - Week 2', 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}, {'value': '36.8', 'groupId': 'OG002'}, {'value': '43.7', 'groupId': 'OG003'}]}]}, {'title': '20% improvement - Week 3', 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}, {'value': '38.2', 'groupId': 'OG002'}, {'value': '59.2', 'groupId': 'OG003'}]}]}, {'title': '20% improvement - Week 4', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}, {'value': '36.8', 'groupId': 'OG002'}, {'value': '59.2', 'groupId': 'OG003'}]}]}, {'title': '50% improvement - Week 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '2.8', 'groupId': 'OG003'}]}]}, {'title': '50% improvement - Week 2', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}, {'value': '4.4', 'groupId': 'OG002'}, {'value': '4.2', 'groupId': 'OG003'}]}]}, {'title': '50% improvement - Week 3', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '2.9', 'groupId': 'OG002'}, {'value': '14.1', 'groupId': 'OG003'}]}]}, {'title': '50% improvement - Week 4', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}, {'value': '8.8', 'groupId': 'OG002'}, {'value': '14.1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.', 'unitOfMeasure': 'Proportion expressed as percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG002', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.13', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '5.09', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '5.25', 'spread': '0.63', 'groupId': 'OG002'}, {'value': '5.27', 'spread': '0.61', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '4.42', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '4.29', 'spread': '0.85', 'groupId': 'OG002'}, {'value': '3.88', 'spread': '0.94', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 (Day 28)', 'description': 'The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Improvement (CGI-I) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG002', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.87', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '3.60', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '3.56', 'spread': '0.88', 'groupId': 'OG002'}, {'value': '3.40', 'spread': '0.87', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.63', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '3.39', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '3.33', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '2.99', 'spread': '1.01', 'groupId': 'OG003'}]}]}, {'title': 'Day 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.47', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '3.28', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '3.13', 'spread': '1.06', 'groupId': 'OG002'}, {'value': '2.79', 'spread': '1.01', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.27', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '1.17', 'groupId': 'OG001'}, {'value': '2.96', 'spread': '0.93', 'groupId': 'OG002'}, {'value': '2.43', 'spread': '0.89', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4 (Day 28)', 'description': 'The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'PANSS Total Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - RO6889450 45 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg once daily (QD) of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG001', 'title': 'Placebo - RO6889450 150 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG002', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG004', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '103.44', 'spread': '12.58', 'groupId': 'OG000'}, {'value': '99.12', 'spread': '10.16', 'groupId': 'OG001'}, {'value': '98.66', 'spread': '9.64', 'groupId': 'OG002'}, {'value': '99.00', 'spread': '11.37', 'groupId': 'OG003'}, {'value': '100.30', 'spread': '11.49', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '75.10', 'spread': '17.53', 'groupId': 'OG000'}, {'value': '76.73', 'spread': '21.09', 'groupId': 'OG001'}, {'value': '76.25', 'spread': '17.89', 'groupId': 'OG002'}, {'value': '79.30', 'spread': '13.68', 'groupId': 'OG003'}, {'value': '67.74', 'spread': '11.50', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With at Least 20% or 50% Improvement in the PANSS Total Score up to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - RO6889450 45 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg once daily (QD) of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG001', 'title': 'Placebo - RO6889450 150 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG002', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG004', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}, {'value': '36.0', 'groupId': 'OG001'}, {'value': '46.3', 'groupId': 'OG002'}, {'value': '53.3', 'groupId': 'OG003'}, {'value': '75.5', 'groupId': 'OG004'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}, {'value': '43.9', 'groupId': 'OG002'}, {'value': '37.8', 'groupId': 'OG003'}, {'value': '69.8', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '28.0', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}, {'value': '48.8', 'groupId': 'OG002'}, {'value': '28.9', 'groupId': 'OG003'}, {'value': '50.9', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.', 'unitOfMeasure': 'Proportion expressed as a percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'CGI-S up to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - RO6889450 45 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg once daily (QD) of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG001', 'title': 'Placebo - RO6889450 150 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG002', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG004', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5.28', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '5.16', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '5.05', 'spread': '0.50', 'groupId': 'OG002'}, {'value': '5.16', 'spread': '0.60', 'groupId': 'OG003'}, {'value': '5.26', 'spread': '0.62', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.33', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '3.73', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '3.56', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '3.90', 'spread': '0.85', 'groupId': 'OG003'}, {'value': '3.06', 'spread': '0.81', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 12', 'description': 'The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'CGI-I up to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - RO6889450 45 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg once daily (QD) of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG001', 'title': 'Placebo - RO6889450 150 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG002', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG004', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3.54', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '3.76', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '3.54', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '3.56', 'spread': '0.84', 'groupId': 'OG003'}, {'value': '3.38', 'spread': '0.84', 'groupId': 'OG004'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.33', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '1.56', 'groupId': 'OG001'}, {'value': '2.30', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '2.65', 'spread': '0.93', 'groupId': 'OG003'}, {'value': '2.00', 'spread': '0.82', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 12', 'description': 'The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'Participants Ready for Discharge From First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ) at 4-Week Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.'}, {'id': 'OG001', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG002', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '79.3', 'upperLimit': '95.1'}, {'value': '83.1', 'groupId': 'OG001', 'lowerLimit': '71.7', 'upperLimit': '91.2'}, {'value': '89.7', 'groupId': 'OG002', 'lowerLimit': '79.9', 'upperLimit': '95.8'}, {'value': '97.2', 'groupId': 'OG003', 'lowerLimit': '90.2', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'after 4-week treatment', 'description': 'The RDQ is a tool used to assess inpatients with schizophrenia on their readiness for discharge from inpatient treatment. It consists of five items that assess suicidality/homicidality, control of aggression/impulsivity, activities of daily living, medication-taking, and delusions/hallucinations interfering with functioning and global status. An additional item examines the overall clinical state of the patient and the final question assesses readiness for discharge. The values reported are the proportion (expressed as a percentage) of participants in each analysis group considered ready for discharge according to the RDQ.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of RO6889450', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo - RO6889450 45 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg once daily (QD) of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG001', 'title': 'Placebo - RO6889450 150 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'OG002', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'OG003', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '65', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.50', 'spread': '69.2', 'groupId': 'OG002'}, {'value': '423.83', 'spread': '43.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.53', 'spread': '111.4', 'groupId': 'OG002'}, {'value': '463.21', 'spread': '73.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '49.67', 'spread': '155.4', 'groupId': 'OG000'}, {'value': '212.27', 'spread': '25.0', 'groupId': 'OG001'}, {'value': '94.57', 'spread': '108.1', 'groupId': 'OG002'}, {'value': '419.41', 'spread': '93.0', 'groupId': 'OG003'}]}]}, {'title': 'Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '59.99', 'spread': '248.3', 'groupId': 'OG000'}, {'value': '274.58', 'spread': '208.8', 'groupId': 'OG001'}, {'value': '108.57', 'spread': '76.4', 'groupId': 'OG002'}, {'value': '390.65', 'spread': '138.4', 'groupId': 'OG003'}]}]}, {'title': 'Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '70.99', 'spread': '320.4', 'groupId': 'OG000'}, {'value': '217.65', 'spread': '491.6', 'groupId': 'OG001'}, {'value': '108.59', 'spread': '55.5', 'groupId': 'OG002'}, {'value': '237.42', 'spread': '541.2', 'groupId': 'OG003'}]}]}, {'title': 'Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77.11', 'spread': '85.5', 'groupId': 'OG000'}, {'value': '165.99', 'spread': '963.0', 'groupId': 'OG001'}, {'value': '92.24', 'spread': '128.5', 'groupId': 'OG002'}, {'value': '265.09', 'spread': '353.6', 'groupId': 'OG003'}]}]}, {'title': 'Day 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.39', 'spread': '46.0', 'groupId': 'OG002'}, {'value': '733.98', 'spread': '65.5', 'groupId': 'OG003'}]}]}, {'title': 'Day 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.13', 'spread': 'NA', 'comment': 'The value was not estimable for data from a single participant.', 'groupId': 'OG002'}, {'value': '139.71', 'spread': '120.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 7 - Day 336', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The efficacy analysis population (EAP) included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.'}, {'id': 'FG001', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'FG002', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'FG003', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}, {'id': 'FG004', 'title': 'Placebo - RO6889450 45 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg once daily (QD) of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}, {'id': 'FG005', 'title': 'Placebo - RO6889450 150 mg', 'description': 'Participants from the placebo arm in the double-blind treatment period that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm started in the extension period.'}], 'periods': [{'title': 'Double-blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '71'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '74'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '56'}, {'groupId': 'FG004', 'numSubjects': '25'}, {'groupId': 'FG005', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '38'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '18'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '287 participants initially randomized in the double-blind treatment period. 11 excluded from final analysis due to having not received assigned study medication or because of re-enrollment. Participants were not required to participate in all study parts and those that did not continue to the double-blind treatment period either discontinued the study during the double-blind treatment period or exited the study after completing the period. 197 continued to the double-blind extension period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '276', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received oral placebo QD for 4 weeks. Participants from this arm that continued on to the extension period were randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks, or up to an additional 44 weeks if they continued to the optional 36-week safety extension.\n\nNote: This arm was only in the double-blind treatment period.'}, {'id': 'BG001', 'title': 'RO6889450 45 mg', 'description': 'Participants received 45 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'BG002', 'title': 'RO6889450 150 mg', 'description': 'Participants received 150 mg of RO6889450 QD for 4, 12, or 48 weeks.'}, {'id': 'BG003', 'title': 'Risperidone 4 mg', 'description': 'Participants received 4 mg of risperidone QD for 4, 12, or 48 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.2', 'spread': '7.1', 'groupId': 'BG000'}, {'value': '34.0', 'spread': '7.0', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '6.5', 'groupId': 'BG002'}, {'value': '32.9', 'spread': '7.1', 'groupId': 'BG003'}, {'value': '33.1', 'spread': '6.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '205', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '239', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '143', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The efficacy analysis population (EAP) was used to determine baseline characteristics. The EAP included all randomized participants who received at least one dose of study medication and who had primary efficacy assessments at baseline and on at least one occasion post-baseline.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-06', 'size': 1694079, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-16T19:00', 'hasProtocol': True}, {'date': '2022-03-25', 'size': 5215744, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-16T19:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 287}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2020-08-12', 'resultsFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-09-15', 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4', 'timeFrame': 'Week 4 (Day 28)', 'description': 'The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in PANSS Factor Scores at Week 4', 'timeFrame': 'Week 4 (Day 28)', 'description': 'PANSS factors are modified groupings of the 30 PANSS items from the original three subscales (positive, negative, and general psychopathology). Each item is rated on a scale of 1 (absent) to 7 (most extreme). The positive symptom factor contains 8 items (score range 8-56); the negative symptom and disorganized thought/cognition factors contain 7 items (score range 7-49); the uncontrolled hostility/excitement, expressive deficit, and anxiety/depression factors contain 4 items (score range 4-28); and the avolition domain contains 3 items (score range 3-21). The negative and positive totals each have a range of 7-49 and the general total has a range of 16-112. Higher scores indicate higher symptom severity.'}, {'measure': 'Proportion of Participants With at Least 20% or 50% Improvement From Baseline in the PANSS Total Score', 'timeFrame': 'Baseline to Week 12', 'description': 'The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.'}, {'measure': 'Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores', 'timeFrame': 'Week 4 (Day 28)', 'description': 'The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms.'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I) Scores', 'timeFrame': 'Week 4 (Day 28)', 'description': 'The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse.'}, {'measure': 'PANSS Total Score at Week 12', 'timeFrame': 'Week 12', 'description': 'The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.'}, {'measure': 'Proportion of Participants With at Least 20% or 50% Improvement in the PANSS Total Score up to Week 12', 'timeFrame': 'Weeks 4, 8, and 12', 'description': 'The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.'}, {'measure': 'CGI-S up to Week 12', 'timeFrame': 'Up to Week 12', 'description': 'The CGI-S measures global severity of illness at a given point in time using a 7-point scale, where 1 = no symptoms and 7 = very severe symptoms.'}, {'measure': 'CGI-I up to Week 12', 'timeFrame': 'Up to Week 12', 'description': 'The CGI-I measures change from the baseline state at subsequent visits using a 7-point scale, where 1 = very much improved and 7 = very much worse.'}, {'measure': 'Participants Ready for Discharge From First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ) at 4-Week Treatment', 'timeFrame': 'after 4-week treatment', 'description': 'The RDQ is a tool used to assess inpatients with schizophrenia on their readiness for discharge from inpatient treatment. It consists of five items that assess suicidality/homicidality, control of aggression/impulsivity, activities of daily living, medication-taking, and delusions/hallucinations interfering with functioning and global status. An additional item examines the overall clinical state of the patient and the final question assesses readiness for discharge. The values reported are the proportion (expressed as a percentage) of participants in each analysis group considered ready for discharge according to the RDQ.'}, {'measure': 'Plasma Concentration of RO6889450', 'timeFrame': 'Day 7 - Day 336'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia, Schizoaffective Disorder']}, 'referencesModule': {'references': [{'pmid': '36369028', 'type': 'DERIVED', 'citation': 'Halff EF, Rutigliano G, Garcia-Hidalgo A, Howes OD. Trace amine-associated receptor 1 (TAAR1) agonism as a new treatment strategy for schizophrenia and related disorders. Trends Neurosci. 2023 Jan;46(1):60-74. doi: 10.1016/j.tins.2022.10.010. Epub 2022 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Participant must be 18 to 45 years of age inclusive\n* Participants with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)\n* Disease duration \\</=10 years\n* Have a current acute exacerbation of schizophrenia of no more than 8 weeks before screening visit and no current signs of apparent lack of treatment response\n* At the time of screening, the participant needs to be either hospitalized or requiring inpatient psychiatric care according to clinical judgment. If the participant has been hospitalized for the current exacerbation, the hospitalization has to be of a maximum of 1 week prior to screening.\n* In previous exacerbations and hospitalizations, the subject has shown a pattern of response to appropriate antipsychotic treatment\n* Medically stable over a period of 3 months (non-psychiatric conditions) prior to screening visit and not expected to require hospitalization or change of treatment for non-psychiatric conditions for the duration of the study\n* Screening and baseline CGI-S \\>/=4 (moderate or worse)\n* Screening and baseline PANSS total score \\>= 80\n* Based on screening and baseline PANSS, scores of \\>/= 4 (moderate or worse) on 2 or more of the following items: delusions, conceptual disorganization, unusual thought content, hallucinatory behavior, or suspiciousness/persecution\n* Body mass index between 18 and 35 kg/m2 inclusive\n* Male and female participants; female participants agree to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug\n\nAdditional inclusion criteria for optional 36-Week Safety Extension Phase\n\n* Successful completion of the 12-week treatment period\n* No signs or symptoms of worsening of the psychiatric or medical status that would preclude the patient from the participation in the 36-Week Safety Extension Phase or affect their ability to comply with the study requirements.\n\nExclusion criteria\n\n* Has been inpatient for \\> 1 week or had any other hospitalization for acute exacerbation of schizophrenia or schizoaffective disorder within the prior 8 weeks or signs of lack of response to antipsychotic treatment\n* Disease duration \\> 10 years\n* Is currently an inpatient on an involuntary basis\n* Subject answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment within one month from screening or between screening and baseline\n* Lifetime history of homicidal behavior\n* Moderate to severe substance use disorder within six months (excluding nicotine) as defined by DSM-5\n* Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder)\n* A prior or current general medical condition that might be impairing cognition or other psychiatric functioning (e.g., migraine headaches requiring prophylaxis treatment, head trauma, dementia, seizure disorder, stroke; or neurodegenerative, inflammatory, infectious, neoplastic, toxic, metabolic, or endocrine conditions)\n* Clinically significant abnormalities in laboratory safety test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), including a) Aspartate aminotransferase (AST), OR alanine aminotransferase (ALT) 2 x upper limit of normal (ULN), OR total bilirubin \\> 1.5 ULN with the exception of known Gilbert syndrome. b) Serum creatinine \\> 1.5 ULN\n* Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV, untreated), or human immunodeficiency virus (HIV)-1 and -2. HCV participants who have been successfully treated and who test negative for HCV RNA are eligible for entry into the study\n* Tardive dyskinesia that is moderate to severe or requires treatment\n* History of neuroleptic malignant syndrome\n* Average triplicate QTcF interval greater than 450 msec for males and 470 msec for females or other clinically significant abnormality on screening ECG based on centralized reading\n* Participant for whom risperidone is contraindicated or who have a documented history of lack of response or intolerance to risperidone or paliperidone or participants with known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperdal\n* Participant treated with a long acting injectable antipsychotic or other antipsychotics that cannot be washed-out within the allotted screening period\n* History of electro-convulsive therapy (ECT) for any reason\n* Participant treated with clozapine at any dose within 12 months of screening visit or participants treated with clozapine at 200 mg/day or above at any time; low dose (\\< 200mg/day) use for insomnia or dyskinesia longer than 12 months prior to screening visit is permitted\n* Participants currently receiving a psychotropic or other medication used as a psychotropic, which cannot be discontinued during the screening period\n* Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenorphine, methadone, cocaine and barbiturates. In case of positive urine drug screen for cannabinoids, the participant may be allowed to enter the study if approved by Medical Monitor\n* Participant has previously received RO6889450\n* Participant received an investigational drug within 28 days or five times the half-life of the investigational drug prior to the first study drug administration\n* Diagnosis of COVID-19 infection (confirmed or presumptive) 4 weeks prior to screening or during screening. Participants can be re-screened after 4 weeks of full recovery in addition to investigator and/or institutional approval to enroll'}, 'identificationModule': {'nctId': 'NCT04512066', 'briefTitle': 'A Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder', 'orgStudyIdInfo': {'id': 'BP41743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '150 mg Once Daily (QD) RO6889450', 'description': 'Participants will receive 150 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks.', 'interventionNames': ['Drug: RO6889450']}, {'type': 'EXPERIMENTAL', 'label': '45 mg QD RO6889450', 'description': 'Participants will receive 45 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks.', 'interventionNames': ['Drug: RO6889450']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive oral placebo QD for 4 weeks. 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