Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00303602
Status:
COMPLETED
Last Update Posted:
2009-06-10
First Post:
2006-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
Sponsor:
Organization:
Raw JSON
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Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks', 'otherNumAffected': 32, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks', 'otherNumAffected': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tongue spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sunburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Chest wall pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Coccydynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Muscle rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Muscle twitching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tongue paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Psychomotor agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}], 'seriousEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 84, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time Course of Change From Baseline in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'title': 'Week 2 (N=82, N=63)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (N=79, N=63)', 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.09', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (N=75, N=58)', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.13', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (N=70, N=54)', 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (N=67, N=51)', 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.18', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.428', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 2 Change from Baseline. There was no adjustment for multiple comparisons.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.859', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 4 Change from Baseline. There was no adjustment for multiple comparisons.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.885', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 8 Change from Baseline. There was no adjustment for multiple comparisons.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.784', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 12 Change from Baseline. There was no adjustment for multiple comparisons.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.465', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-value for Week 16 Change from Baseline. There was no adjustment for multiple comparisons', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Visit 2 (Baseline) to Visit 7 (16 Weeks)', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.', 'unitOfMeasure': 'kilograms/square meters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '1.49', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.442', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Change Difference', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.67', 'ciUpperLimit': '0.30', 'estimateComment': 'Change = Endpoint minus baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)', 'unitOfMeasure': 'kilograms/square meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '1.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.328', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Change Difference', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.32', 'estimateComment': 'Change = Endpoint minus baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (16 Weeks)', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.', 'unitOfMeasure': 'kilograms/square meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.42', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '0.57', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.385', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (16 Weeks)', 'description': 'Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in Waist Circumference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'spread': '5.25', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '5.30', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.914', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square Mean Change Difference', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-1.65', 'ciUpperLimit': '1.84', 'estimateComment': 'Change = endpoint minus baseline', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Waist circumference is measured on a bare abodomen just above the hip bone.', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'title': 'Up to Week 2 (N=82, N=63)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Up to Week 4 (N=79, N=63)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Up to Week 8 (N=75, N=58)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Up to Week 12 (N=70, N=54)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Up to Week 16 (N=67, N=51)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.325', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Up to Week 16 p-value', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2 (Baseline) to Visit 7 (Week 16)', 'description': 'Percentage loss of body weight = 100\\*(postbaseline weight - baseline weight)/baseline weight', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discontinuing the Trial by Visit (Week)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'title': 'Visit 3 (Week 2) Discontinuations', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 (Week 4) Discontinuations', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5 (Week 8) Discontinuations', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 (Week 12) Discontinuations', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7 (Week 16) Discontinuations', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2 (Baseline) to Visit 7 (Week 16)', 'description': 'The number of participants who discontinued by visit (non-cumulative).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.21', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '-5.02', 'spread': '2.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.344', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.1', 'spread': '11.62', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '10.83', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '0.3', 'spread': '7.55', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '8.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.708', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Systolic Blood Pressure Change to Endpoint p-value', 'statisticalMethod': 'Rank-Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.453', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Diastolic Blood Pressure Change to Endpoint p-value', 'statisticalMethod': 'Rank-Sum Test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Sitting blood pressure, taken from the same arm.', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.74', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'High-Density Lipoprotein Cholesterol', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Low-Density Lipoprotein Cholesterol (N=73, N=57)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.187', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Total Cholesterol Change to Endpoint p-value', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.', 'testedNonInferiority': False}, {'pValue': '0.163', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'High-Density Lipoprotein Cholesterol Change to Endpoint p-value', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.', 'testedNonInferiority': False}, {'pValue': '0.323', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Low-Density Lipoprotein Cholesterol Change to Endpoint p-value', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.', 'testedNonInferiority': False}, {'pValue': '0.581', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Triglycerides Change to Endpoint p-value', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.', 'unitOfMeasure': 'millimole/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.227', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.', 'unitOfMeasure': 'millimole/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'spread': '17.72', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '5.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Patients should be fasting a minimum of eight hours prior to serum insulin measurement.', 'unitOfMeasure': 'microIU/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.834', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals of this regression in CMH test.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with last observation carried forward'}, {'type': 'SECONDARY', 'title': 'Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.5', 'spread': '58.91', 'groupId': 'OG000'}, {'value': '-9.8', 'spread': '62.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.022', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Ranks of change from baseline were regressed on ranks of baseline value of assay. Treatments compared using residuals on this regression in CMH test.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.', 'unitOfMeasure': 'percent sensitivity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population with last observation carried forward.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'title': 'Baseline - Metabolic Syndrome (N=82, N=65)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Endpoint - Metabolic Syndrome (N=70, N=52)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.515', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'Endpoint Metabolic Syndrome p-value', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Patient meets definition of metabolic syndrome if they have \\>=3 risk factors: Waist circumference (men\\>102cm, women\\>88cm); triglycerides \\>=1.7mmol/L; HDL cholesterol (men\\<1.04mmol/L, women\\<1.30mmol/L); blood pressure \\>135/\\>=85 mmHg; Fasting glucose \\>=6.1mmol/L', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.118', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.79', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '1.60', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'OG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.61', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '2.72', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': "Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'FG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol entry criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SODO', 'description': 'Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks'}, {'id': 'BG001', 'title': 'SOT', 'description': 'Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.6', 'spread': '13.13', 'groupId': 'BG000'}, {'value': '38.7', 'spread': '12.23', 'groupId': 'BG001'}, {'value': '38.6', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence of Metabolic Syndrome', 'classes': [{'title': 'No', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Psychiatric Illness', 'classes': [{'title': 'Schizophrenia', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Schizophreniform', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Schizoaffective disorder', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Other related psychiatric disorder', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Bipolar disorder', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'African Descent', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Caucasian', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}, {'title': 'East/Southeast Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'First Nations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Blood Pressure', 'classes': [{'title': 'Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '120.3', 'spread': '16.45', 'groupId': 'BG000'}, {'value': '119.0', 'spread': '12.49', 'groupId': 'BG001'}, {'value': '119.7', 'spread': '14.82', 'groupId': 'BG002'}]}]}, {'title': 'Diastolic Blood Pressure', 'categories': [{'measurements': [{'value': '77.6', 'spread': '9.62', 'groupId': 'BG000'}, {'value': '75.8', 'spread': '9.15', 'groupId': 'BG001'}, {'value': '76.8', 'spread': '9.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '28.0', 'spread': '5.63', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '4.76', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '5.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms/meters-squared', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Clinical Global Impression-Severity Scale', 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '0.78', 'groupId': 'BG000'}, {'value': '3.2', 'spread': '0.85', 'groupId': 'BG001'}, {'value': '3.1', 'spread': '0.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Glucose', 'classes': [{'categories': [{'measurements': [{'value': '5.1', 'spread': '0.77', 'groupId': 'BG000'}, {'value': '5.0', 'spread': '0.46', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '0.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimole/Liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Insulin', 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '14.65', 'groupId': 'BG000'}, {'value': '10.0', 'spread': '7.18', 'groupId': 'BG001'}, {'value': '11.9', 'spread': '12.06', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'micro International Unit/milliliter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Lipoproteins', 'classes': [{'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.01', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '1.01', 'groupId': 'BG001'}, {'value': '5.1', 'spread': '1.0', 'groupId': 'BG002'}]}]}, {'title': 'High-Density Lipoprotein Cholesterol', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.40', 'groupId': 'BG000'}, {'value': '1.3', 'spread': '0.34', 'groupId': 'BG001'}, {'value': '1.3', 'spread': '0.37', 'groupId': 'BG002'}]}]}, {'title': 'Low-Density Lipoprotein Cholesterol', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.81', 'groupId': 'BG000'}, {'value': '3.0', 'spread': '0.88', 'groupId': 'BG001'}, {'value': '3.1', 'spread': '0.84', 'groupId': 'BG002'}]}]}, {'title': 'Triglycerides', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.77', 'groupId': 'BG000'}, {'value': '1.7', 'spread': '0.90', 'groupId': 'BG001'}, {'value': '1.7', 'spread': '0.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimole/Liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Global Assessment of Functioning Scale', 'classes': [{'categories': [{'measurements': [{'value': '63.4', 'spread': '12.82', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '12.39', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '12.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Glycosylated Hemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '0.45', 'groupId': 'BG000'}, {'value': '5.5', 'spread': '0.38', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '0.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.0', 'spread': '10.18', 'groupId': 'BG000'}, {'value': '168.9', 'spread': '10.23', 'groupId': 'BG001'}, {'value': '169.5', 'spread': '10.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjective Appetite (Visual Analog Scale)', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'spread': '20.85', 'groupId': 'BG000'}, {'value': '65.7', 'spread': '19.24', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '20.16', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Subjective Well-Being Under Neuroleptic Treatment - Short Form', 'classes': [{'title': 'Total Score', 'categories': [{'measurements': [{'value': '85.5', 'spread': '15.59', 'groupId': 'BG000'}, {'value': '85.6', 'spread': '15.00', 'groupId': 'BG001'}, {'value': '85.5', 'spread': '15.28', 'groupId': 'BG002'}]}]}, {'title': 'Social Integration Subscale', 'categories': [{'measurements': [{'value': '17.0', 'spread': '4.38', 'groupId': 'BG000'}, {'value': '17.0', 'spread': '3.97', 'groupId': 'BG001'}, {'value': '17.0', 'spread': '4.19', 'groupId': 'BG002'}]}]}, {'title': 'Physical Functioning Subscale', 'categories': [{'measurements': [{'value': '17.0', 'spread': '3.53', 'groupId': 'BG000'}, {'value': '17.2', 'spread': '3.26', 'groupId': 'BG001'}, {'value': '17.1', 'spread': '3.41', 'groupId': 'BG002'}]}]}, {'title': 'Mental Functioning Subscale', 'categories': [{'measurements': [{'value': '16.7', 'spread': '4.02', 'groupId': 'BG000'}, {'value': '16.7', 'spread': '4.20', 'groupId': 'BG001'}, {'value': '16.7', 'spread': '4.09', 'groupId': 'BG002'}]}]}, {'title': 'Self-Control Subscale', 'categories': [{'measurements': [{'value': '17.0', 'spread': '3.45', 'groupId': 'BG000'}, {'value': '17.3', 'spread': '4.15', 'groupId': 'BG001'}, {'value': '17.1', 'spread': '3.76', 'groupId': 'BG002'}]}]}, {'title': 'Emotional Regulation Subscale', 'categories': [{'measurements': [{'value': '17.6', 'spread': '4.07', 'groupId': 'BG000'}, {'value': '17.4', 'spread': '3.82', 'groupId': 'BG001'}, {'value': '17.5', 'spread': '3.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 4 to 24. Total score ranges from 20 to 120.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist Circumference', 'classes': [{'categories': [{'measurements': [{'value': '96.1', 'spread': '13.24', 'groupId': 'BG000'}, {'value': '97.2', 'spread': '12.97', 'groupId': 'BG001'}, {'value': '96.6', 'spread': '13.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '81.1', 'spread': '18.97', 'groupId': 'BG000'}, {'value': '81.2', 'spread': '17.05', 'groupId': 'BG001'}, {'value': '81.1', 'spread': '18.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-05', 'studyFirstSubmitDate': '2006-03-15', 'resultsFirstSubmitDate': '2008-12-19', 'studyFirstSubmitQcDate': '2006-03-15', 'lastUpdatePostDateStruct': {'date': '2009-06-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-04-09', 'studyFirstPostDateStruct': {'date': '2006-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time Course of Change From Baseline in Body Mass Index (BMI)', 'timeFrame': 'Visit 2 (Baseline) to Visit 7 (16 Weeks)', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of change from baseline to endpoint. Change = Endpoint (Week 16) minus Baseline (Week 0)'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (16 Weeks)', 'description': 'Body mass index is an estimate of body fat based on body weight divided by height squared. Comparisons of change from baseline to endpoint between participants who completed their treatment. Change = Endpoint value minus Baseline value.'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in Weight', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (16 Weeks)', 'description': 'Weight of undressed patient (undergarments allowed), measured preferably at the same time each day.'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in Waist Circumference', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Waist circumference is measured on a bare abodomen just above the hip bone.'}, {'measure': 'Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period', 'timeFrame': 'Visit 2 (Baseline) to Visit 7 (Week 16)', 'description': 'Percentage loss of body weight = 100\\*(postbaseline weight - baseline weight)/baseline weight'}, {'measure': 'Number of Participants Discontinuing the Trial by Visit (Week)', 'timeFrame': 'Visit 2 (Baseline) to Visit 7 (Week 16)', 'description': 'The number of participants who discontinued by visit (non-cumulative).'}, {'measure': 'Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Participant chooses where they think their appetite lies on a 10 centimeter line between two anchors (0 - very poor appetite and 10 - very strong appetite). The possible range of scores is 0 to 100 and represents millimeters on the 10 centimeter line.'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in Blood Pressure', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Sitting blood pressure, taken from the same arm.'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Patients should be fasting a minimum of eight hours prior to lipoprotein measurements.'}, {'measure': 'Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Patients should be fasting a minimum of eight hours prior to plasma glucose measurement.'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Patients should be fasting a minimum of eight hours prior to serum insulin measurement.'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)'}, {'measure': 'Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'HOMA-S is an estimate of insulin sensitivity. The HOMA model is a computer model of the glucose insulin feedback system in the fasted state. The model consists of a number of non-linear empirical equations describing the functions of organs and tissues involved in glucose regulation.'}, {'measure': 'Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Patient meets definition of metabolic syndrome if they have \\>=3 risk factors: Waist circumference (men\\>102cm, women\\>88cm); triglycerides \\>=1.7mmol/L; HDL cholesterol (men\\<1.04mmol/L, women\\<1.30mmol/L); blood pressure \\>135/\\>=85 mmHg; Fasting glucose \\>=6.1mmol/L'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': 'Measures subjective well-being for previous 7 days. 20 items covering 5 health domains (subscales) (4 items each): emotional regulation, self-control, mental functioning, social integration, and physical functioning. Individual scores range from 1 (not at all) to 6 (very much). Subscale scores range from 1 to 24. Total score ranges from 1 to 120.'}, {'measure': 'Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale', 'timeFrame': 'Visit 2 (Baseline) and Visit 7 (Week 16)', 'description': "Measures physician's judgment of a patient's overall level of functioning. Ratings are based on a scale of 1 to 100, with the following classification range: 1-10 (severely impaired) to 91-100 (superior functioning)."}]}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Schizoaffective Disorder', 'Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '20840778', 'type': 'DERIVED', 'citation': 'Case M, Treuer T, Karagianis J, Hoffmann VP. The potential role of appetite in predicting weight changes during treatment with olanzapine. BMC Psychiatry. 2010 Sep 14;10:72. doi: 10.1186/1471-244X-10-72.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (Patients must):\n\n* Be at least 18 years old\n* Have gained weight while taking olanzapine\n* Be able to visit the doctor's office seven times over 4 months (17 weeks)\n\nExclusion Criteria (Patients must NOT):\n\n* Have started a weight loss program within the last 8 weeks\n* Have an illness that might affect patient's weight during the study\n* Have an allergy to phenylalanine, mannitol or saccharine\n* Be taking any medication (except for olanzapine) that might affect patient's weight"}, 'identificationModule': {'nctId': 'NCT00303602', 'briefTitle': 'Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)', 'orgStudyIdInfo': {'id': '10268'}, 'secondaryIdInfos': [{'id': 'F1D-CA-S063'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Sublingual orally disintegrating olanzapine (SODO)', 'interventionNames': ['Drug: Sublingual orally disintegrating olanzapine (SODO)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Oral olanzapine', 'interventionNames': ['Drug: Oral olanzapine']}], 'interventions': [{'name': 'Sublingual orally disintegrating olanzapine (SODO)', 'type': 'DRUG', 'otherNames': ['LY170053', 'Zydis'], 'description': '5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.', 'armGroupLabels': ['A']}, {'name': 'Oral olanzapine', 'type': 'DRUG', 'otherNames': ['LY170053', 'Zyprexa'], 'description': '5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', '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': 33.11921, 'lon': -117.08642}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', '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': 33.77391, 'lon': -117.94145}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', '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': 32.67811, 'lon': -117.0992}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', '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': 33.78779, 'lon': -117.85311}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', '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': 33.749, 'lon': -84.38798}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', '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': 36.17497, 'lon': -115.13722}}, {'zip': '10312', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', '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': 40.56233, 'lon': -74.13986}}, {'zip': 'V2A 4M4', 'city': 'Penticton', 'state': 'British Columbia', 'country': 'Canada', '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': 49.48062, 'lon': -119.58584}}, {'zip': 'R3E 3N4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', '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': 49.8844, 'lon': -97.14704}}, {'zip': 'B2Y 3Z9', 'city': 'Dartmouth', 'state': 'Nova Scotia', 'country': 'Canada', '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': 44.67134, 'lon': -63.57719}}, {'zip': 'B3H 2E2', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', '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': 44.64269, 'lon': -63.57688}}, {'zip': 'B1S 2E8', 'city': 'Sydney', 'state': 'Nova Scotia', 'country': 'Canada', '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': 46.1351, 'lon': -60.1831}}, {'zip': 'N7L 1B7', 'city': 'Chatham', 'state': 'Ontario', 'country': 'Canada', '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': 42.41224, 'lon': -82.18494}}, {'zip': 'P3C 1T4', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', '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': 46.49, 'lon': -80.99001}}, {'zip': 'K7L 4X3', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', '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': 44.22976, 'lon': -76.48098}}, {'zip': 'N9C 3Z4', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', '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': 42.30008, 'lon': -83.01654}}, {'zip': 'J1G 1W4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', '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': 45.40008, 'lon': -71.89908}}, {'zip': '01030', 'city': 'Mexico City', 'country': 'Mexico', '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': 19.42847, 'lon': -99.12766}}, {'zip': '3816 CP', 'city': 'Amersfoort', 'country': 'Netherlands', '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': 52.155, 'lon': 5.3875}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', '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': 51.9225, 'lon': 4.47917}}, {'zip': '00918', 'city': 'San Juan', 'country': 'Puerto Rico', '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': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM 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'}}}}