Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00129220
Status:
COMPLETED
Last Update Posted:
2010-12-28
First Post:
2005-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D000087122', 'term': 'Mania'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Identified errors were corrected.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks', 'otherNumAtRisk': 105, 'otherNumAffected': 78, 'seriousNumAtRisk': 105, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks', 'otherNumAtRisk': 20, 'otherNumAffected': 14, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks', 'otherNumAtRisk': 96, 'otherNumAffected': 64, 'seriousNumAtRisk': 96, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hunger', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood pressure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Electrocardiogram qt prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Glycosylated haemoglobin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Depressive symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 105, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.6', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '-14.3', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '-6.8', 'spread': '14.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.62', 'ciLowerLimit': '-8.87', 'ciUpperLimit': '-2.37', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 weeks', 'description': 'The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.0', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '-14.7', 'spread': '13.1', 'groupId': 'OG001'}, {'value': '-10.1', 'spread': '15.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.774', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.78', 'ciLowerLimit': '-6.15', 'ciUpperLimit': '4.59', 'estimateComment': 'Least Squares Mean Difference = Olazapine minus Haloperidol.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day'}], 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.0', 'ciLowerLimit': '1.6', 'ciUpperLimit': '40.4', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Haloperidol.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 weeks', 'description': 'Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.15', 'ciUpperLimit': '0.21', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Haloperidol.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 weeks', 'description': "A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'title': '3-Week Change', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '1.5', 'groupId': 'OG002'}]}]}, {'title': '6-Week Change', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.87', 'ciUpperLimit': '-0.15', 'pValueComment': 'P-value for 3-Week Change.', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.722', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.57', 'pValueComment': 'P-value for 6-Week Change.', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Haloperidol.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': "A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'title': '3 Week Response Rate', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}, {'value': '44.3', 'groupId': 'OG002'}]}]}, {'title': '6 Week Response Rate', 'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}, {'value': '55.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.333', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '-6.7', 'ciUpperLimit': '20.1', 'pValueComment': 'P-value for 3-Week Response Rate.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.908', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.3', 'ciLowerLimit': '-21.0', 'ciUpperLimit': '18.4', 'pValueComment': 'P-value for 6-Week Response Rate.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'title': '3-Week Remission Rate', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}, {'value': '65.0', 'groupId': 'OG001'}, {'value': '41.2', 'groupId': 'OG002'}]}]}, {'title': '6-Week Remission Rate', 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000'}, {'value': '60.0', 'groupId': 'OG001'}, {'value': '52.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.384', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '-7.3', 'ciUpperLimit': '19.2', 'pValueComment': 'P-value for 3-Week Remission Rate.', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Placebo.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.982', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-21.3', 'ciUpperLimit': '21.8', 'pValueComment': 'P-value is for 6-Week Remission Rate', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Haloperidol.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Switched to Symptomatic Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'title': '3-Week Symptomatic Depression Rate', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}]}]}, {'title': '6-Week Symptomatic Depression Rate', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.698', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '4.9', 'pValueComment': 'P-value for 3-Week Symptomatic Depression Rate.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.1', 'ciLowerLimit': '-31.7', 'ciUpperLimit': '3.4', 'pValueComment': 'P-value for 6-Week Symptomatic Depression Rate.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had HAMD-17 total scores ≤7 at baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'title': '3-Week Change', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '-0.0', 'spread': '5.3', 'groupId': 'OG002'}]}]}, {'title': '6-Week Change', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '5.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.019', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.48', 'ciLowerLimit': '-2.71', 'ciUpperLimit': '-0.25', 'pValueComment': 'P-value for 3-Week Change.', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Placebo.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.855', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-1.95', 'ciUpperLimit': '1.62', 'pValueComment': 'P-value for 6-Week Change.', 'estimateComment': 'Least Squares Mean Difference = Olanzapine minus Haloperidol.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set: participants who had baseline and post-baseline measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Switched to Syndromic Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'title': '3-Week Syndromic Depression Rate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}, {'title': '6-Week Syndromic Depression Rate', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.6', 'ciLowerLimit': '-14.9', 'ciUpperLimit': '5.7', 'pValueComment': 'P-value for 6-Week Syndromic Depression Rate.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set (participants who had baseline and post-baseline measurement) who had manic (not mixed) episode at baseline.'}, {'type': 'SECONDARY', 'title': 'Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'OG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '1.19', 'groupId': 'OG001'}, {'value': '0.30', 'spread': '0.91', 'groupId': 'OG002'}]}]}, {'title': 'Maximum Change from Baseline', 'categories': [{'measurements': [{'value': '0.70', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '2.89', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '1.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Maximum Change from Baseline.', 'statisticalMethod': 'Wilcoxon Rank Sum', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set (participants who had baseline and post-baseline measurements). Participants were included in the treatment group for which they actually received treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'FG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}], 'periods': [{'title': 'Study Period II', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '99'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '28'}]}, {'type': 'Entry Criteria Not Met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}, {'title': 'Study Period III', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'Study Period I was a week-long Screening Period. Study Period II was a 3-week-long Early Double-Blind Period. Study Period III was a 3-week-long Last Double-Blind Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks'}, {'id': 'BG001', 'title': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '49.3', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '10.9', 'groupId': 'BG002'}, {'value': '43.4', 'spread': '11.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Illness Episode: Manic versus Mixed', 'classes': [{'title': 'Manic', 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '203', 'groupId': 'BG003'}]}]}, {'title': 'Mixed', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Current Illness Episode: Psychotic versus Nonpsychotic', 'classes': [{'title': 'Psychotic', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}, {'title': 'Nonpsychotic', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '181', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hospitalization Status', 'classes': [{'title': 'In-Patients', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'Out-Patients', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '132', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Psychosis', 'classes': [{'title': 'Mood-Congruent', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}]}, {'title': 'Mood-Incongruent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Type of psychosis for those participants who had a current illness episode of psychotic (total number of participants with data in this baseline measure will be less than the total in each arm)', 'unitOfMeasure': 'participants'}, {'title': '17-Item Hamilton Depression Rating Scale Total Score', 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '3.9', 'groupId': 'BG000'}, {'value': '4.1', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '4.9', 'spread': '4.5', 'groupId': 'BG002'}, {'value': '4.7', 'spread': '4.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age of Onset of Illness', 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '37.7', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '30.9', 'spread': '10.7', 'groupId': 'BG002'}, {'value': '31.6', 'spread': '11.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression-Severity of Illness, Bipolar Version (CGI-BP)', 'classes': [{'title': 'Mania', 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '4.6', 'spread': '0.8', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '4.2', 'spread': '1.0', 'groupId': 'BG003'}]}]}, {'title': 'Depression', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '1.3', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'BG003'}]}]}, {'title': 'Overall Mood', 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '4.4', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '4.1', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '4.1', 'spread': '1.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms, depressive symptoms, and overall mood symptoms. Each of the three symptoms are on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '162.74', 'spread': '8.07', 'groupId': 'BG000'}, {'value': '162.10', 'spread': '7.87', 'groupId': 'BG001'}, {'value': '163.09', 'spread': '9.66', 'groupId': 'BG002'}, {'value': '162.84', 'spread': '8.76', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Length of Current Illness Episode', 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '22.9', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '22.0', 'groupId': 'BG001'}, {'value': '33.5', 'spread': '25.4', 'groupId': 'BG002'}, {'value': '34.1', 'spread': '23.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Positive and Negative Syndrome Scale Positive Subscale Score', 'classes': [{'categories': [{'measurements': [{'value': '11.5', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '11.3', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '10.7', 'spread': '4.7', 'groupId': 'BG002'}, {'value': '11.1', 'spread': '4.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '60.88', 'spread': '11.69', 'groupId': 'BG000'}, {'value': '59.20', 'spread': '9.87', 'groupId': 'BG001'}, {'value': '61.86', 'spread': '13.78', 'groupId': 'BG002'}, {'value': '61.17', 'spread': '12.49', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Young Mania Rating Scale (YMRS) Total Score', 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '26.9', 'spread': '5.6', 'groupId': 'BG002'}, {'value': '27.3', 'spread': '5.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-10', 'studyFirstSubmitDate': '2005-08-08', 'resultsFirstSubmitDate': '2010-01-21', 'studyFirstSubmitQcDate': '2005-08-08', 'lastUpdatePostDateStruct': {'date': '2010-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-01-21', 'studyFirstPostDateStruct': {'date': '2005-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to 3 Week Endpoint in Young Mania Rating Scale (YMRS) Total Score', 'timeFrame': 'Baseline, 3 weeks', 'description': 'The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to 6 Week Endpoint in Young Mania Rating Scale (YMRS)', 'timeFrame': 'Baseline, 6 weeks', 'description': 'The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.'}, {'measure': 'Remission Rate of Bipolar Disorder (Olanzapine Versus Haloperidol)', 'timeFrame': '6 weeks', 'description': 'Remission of bipolar disorder was defined as completing the 6-week period with meeting the criteria for Young Mania Rating Scale (YMRS) total score of 12 or less and 17-Item Hamilton Depression Rating Scale (HAMD-17) total scores of 7 or less at Week 6. YMRS is an 11-item scale measuring severity of manic episodes; total score ranges = 0 (normal) to 60 (severe). The 17-item HAMD measures depression severity; total score ranges = 0 (normal) to 52 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.'}, {'measure': 'Change From Baseline to 6 Week Endpoint in Clinical Global Impressions - Bipolar Version (CGI-BP), Overall Severity of Illness', 'timeFrame': 'Baseline, 6 weeks', 'description': "A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of overall mood symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients)."}, {'measure': 'Change From Baseline to 3 Week and 6 Week Endpoints in Clinical Global Impression - Bipolar Version (CGI-BP) Mania Subscale', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': "A global rating scale for severity of patients adapted to bipolar disorder. Measures severity of the patient's overall severity of manic symptoms on a scale of 1 (normal, not at all ill) to 7 (among the most extremely ill patients)."}, {'measure': 'Response Rate of Manic Symptoms at 3 Weeks and 6 Weeks', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Participants who had 50 percent or more decrease from the baseline in YMRS total scores were defined as a responder. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. Response Rate (percent) = number of patients meeting response criterion for manic symptom divided by number of patients in treatment arm, multiplied by 100.'}, {'measure': 'Remission Rate of Manic Symptoms at 3 Weeks and 6 Weeks', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Participants who had a YMRS total score of 12 or less were considered to be in remission of manic symptoms. YMRS is an 11-item scale that measures severity of manic episodes; total score ranges from 0 (normal) to 60 (severe). Remission Rate (percent) = number of patients meeting remission criteria divided by number of patients in treatment arm, multiplied by 100.'}, {'measure': 'Percentage of Participants Who Switched to Symptomatic Depression', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Switch to symptomatic depression was defined as HAMD-17 total score ≥13 at any time in the participants with HAMD-17 total scores ≤7 at baseline. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).'}, {'measure': 'Change From Baseline to 3 Week and 6 Week Endpoints in the Positive Subscore of Positive and Negative Syndrome Scale (PANSS)', 'timeFrame': 'Baseline, 3 weeks, 6 weeks', 'description': 'Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For this study, the score was converted to 0 to 6 for each item range; hence, the total positive subscale score ranges from 0 to 42.'}, {'measure': 'Percentage of Participants Who Switched to Syndromic Depression', 'timeFrame': '3 weeks, 6 weeks', 'description': 'Switch to syndromic depression was operationally defined by meeting both of the following criteria: At baseline, the symptoms did not meet the criteria for a mixed episode based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR). The critiera were met for a Major Depressive Episode (MDE), at any point after randomization, based on DSM-IV-TR. Rather than the 2-week period required for an MDE in the DSM-IV-TR, the patient had to meet the criteria of an MDE for at least 7 consecutive days (during Weeks 1 through 6).'}, {'measure': 'Maximum Change From Baseline During 6-Week Period in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score', 'timeFrame': 'Baseline to 6 weeks', 'description': 'Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) is a scale used to evaluate the severity of drug induced extra-pyramidal symptoms occurring during antipsychotic drug treatment. Scale consists of 8 individual symptom scales with scores ranging from 0 (none/normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe).'}]}, 'conditionsModule': {'keywords': ['Manic or mixed episode associated with bipolar I disorder'], 'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '22134043', 'type': 'DERIVED', 'citation': 'Katagiri H, Takita Y, Tohen M, Higuchi T, Kanba S, Takahashi M. Efficacy and safety of olanzapine in the treatment of Japanese patients with bipolar I disorder in a current manic or mixed episode: a randomized, double-blind, placebo- and haloperidol-controlled study. J Affect Disord. 2012 Feb;136(3):476-84. doi: 10.1016/j.jad.2011.10.045. Epub 2011 Nov 30.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the efficacy of olanzapine in the treatment of manic or mixed symptoms associated with bipolar I disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the criteria for manic or mixed episodes according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) and have a diagnosis of "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed".\n* Have a total score on the Young Mania Rating Scale (YMRS) of at least 20 at Visit 1 and Visit 2.\n\nExclusion Criteria:\n\n* Have received an antidepressant or a psychostimulant within 5 days prior to Visit 1.\n* The duration of the current episode is more than 90 days at Visit 1.\n* Have a history or a diagnosis of diabetes mellitus.\n* Have received any psychotropic medication within 2 days prior to Visit 2 (except for benzodiazepines).'}, 'identificationModule': {'nctId': 'NCT00129220', 'briefTitle': 'Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Placebo- and Haloperidol-Controlled Double-Blind Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder', 'orgStudyIdInfo': {'id': '9636'}, 'secondaryIdInfos': [{'id': 'F1D-JE-BMAC', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Olanzapine', 'description': 'olanzapine: 5 to 20 mg per day for 6 weeks', 'interventionNames': ['Drug: olanzapine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Haloperidol', 'description': 'haloperidol: 2.5 to 10 mg per day for 6 weeks', 'interventionNames': ['Drug: haloperidol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'olanzapine', 'type': 'DRUG', 'otherNames': ['LY170053', 'Zyprexa'], 'description': '5-20 mg, oral, once daily (evening), for 6 weeks', 'armGroupLabels': ['Olanzapine']}, {'name': 'haloperidol', 'type': 'DRUG', 'description': '2.5-10 mg, oral, twice daily (morning and evening), for 6 weeks.', 'armGroupLabels': ['Haloperidol']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo, oral tablets, twice daily (morning and evening), for 3 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '470-1168', 'city': 'Aichi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.51879, 'lon': 130.62158}}, {'zip': '010-1654', 'city': 'Akita', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.71667, 'lon': 140.11667}}, {'zip': '283-0062', 'city': 'Chiba', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '807-8555', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '370-2455', 'city': 'Gunma', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '004-0841', 'city': 'Hokkaido', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '663-8501', 'city': 'Hyōgo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.36667, 'lon': 144.43333}}, {'zip': '236-0037', 'city': 'Kanagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.58333, 'lon': 139.91667}}, {'zip': '861-0002', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '384-8540', 'city': 'Nagano', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '700-8558', 'city': 'Okayama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '904-2222', 'city': 'Okinawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.33583, 'lon': 127.80139}}, {'zip': '561-0803', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '842-0192', 'city': 'Saga', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'zip': '343-0032', 'city': 'Saitama', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.90807, 'lon': 139.65657}}, {'zip': '160-0023', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Chief Medical Officer', 'oldOrganization': 'Eli Lilly'}}}}