Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT00299702
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2006-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Chile', 'Denmark', 'India', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}, {'id': 'D018967', 'term': 'Risperidone'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '609-730-3693', 'title': 'Therapeutic Area Lead', 'organization': 'Ortho-McNeil, Inc. N America Pharm CNS/IM'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '15% of subjects did not meet stability inclusion criteria; many received supplemental antipsychotics post-randomization; biweekly visits may have increased aripiprazole adherence; numerous early dropouts may have led to dependent censoring and bias.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.', 'eventGroups': [{'id': 'EG000', 'title': 'RISPERDAL CONSTA', 'description': '25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks', 'otherNumAtRisk': 179, 'otherNumAffected': 151, 'seriousNumAtRisk': 179, 'seriousNumAffected': 31}, {'id': 'EG001', 'title': 'Abilify', 'description': '10-30 mg once daily oral for 104 weeks', 'otherNumAtRisk': 176, 'otherNumAffected': 141, 'seriousNumAtRisk': 176, 'seriousNumAffected': 35}], 'otherEvents': [{'term': 'HYPERPROLACTINAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SALIVARY HYPERSECRETION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'WEIGHT INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'TREMOR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'AKATHISIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'HYPERSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SOMNOLENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SEDATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 51}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 30}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SCHIZOPHRENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 15}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'RESTLESSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SLEEP DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'PANCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'CARDIO-RESPIRATORY ARREST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'GOITRE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ANAL FISSURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'IRRITABLE BOWEL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'MELAENA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'JOINT DISLOCATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'MULTIPLE DRUG OVERDOSE ACCIDENTAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ROAD TRAFFIC ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DIABETIC KETOACIDOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'AKATHISIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SCHIZOPHRENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'AGGRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DEPRESSION SUICIDAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'AFFECT LABILITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ALCOHOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'COMPLETED SUICIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'DRUG DEPENDENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'HOMICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'MANIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'MENTAL STATUS CHANGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 176, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risperdal Consta', 'description': '25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks'}, {'id': 'OG001', 'title': 'Abilify', 'description': '10-30 mg once daily oral for 104 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '197'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '169'}]}]}], 'analyses': [{'pValue': '0.684', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Hochberg procedure was used for adjusting multiple endpoint comparisons', 'groupDescription': 'Null hypothesis: there is no difference in time to relapse', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Insufficient number of subjects who had an event for median estimation.', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 to relapse', 'description': 'Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.'}, {'type': 'PRIMARY', 'title': 'Time in Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Risperdal Consta', 'description': '25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks'}, {'id': 'OG001', 'title': 'Abilify', 'description': '10-30 mg once daily oral for 104 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '373.5', 'spread': '282.6', 'groupId': 'OG000'}, {'value': '356.7', 'spread': '291.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.646', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Hochberg procedure was used for adjusting multiple endpoint comparisons', 'groupDescription': 'Null hypothesis: there is no difference in time in remission between the two treatment groups', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 to last PANSS measurement', 'description': 'Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Risperdal Consta', 'description': '25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks'}, {'id': 'FG001', 'title': 'Abilify', 'description': '10-30 mg once daily oral for 104 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '179'}, {'groupId': 'FG001', 'numSubjects': '176'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '50'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Insufficient Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Admin issues, sponsor decision, etc.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'The first patient in was on February 28, 2006; last patient out was on January 26, 2009. Enrollment occurred across multiple sites in the United States, Argentina, Chile, and India and patients were enrolled from outpatient psychiatric clinics associated with private medical practices, private clinical trial sites, and academic medical centers.', 'preAssignmentDetails': 'A Screening Visit (maximum of 14 days) prior to the Treatment Phase. Baseline included psychiatric exam, lab, ECG, and schizophrenia symptom rating scale. Subjects were permitted to remain on previous psychotropic medications (i.e., antipsychotic, antidepressant, mood stabilizer, anxiolytics) up to the first 4 weeks of the Treatment Phase.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Risperdal Consta', 'description': '25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks'}, {'id': 'BG001', 'title': 'Abilify', 'description': '10-30 mg once daily oral for 104 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '350', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '11.66', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '11.49', 'groupId': 'BG001'}, {'value': '38', 'spread': '11.56', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'India', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'South America', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-22', 'studyFirstSubmitDate': '2006-03-03', 'resultsFirstSubmitDate': '2010-01-26', 'studyFirstSubmitQcDate': '2006-03-03', 'lastUpdatePostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-04', 'studyFirstPostDateStruct': {'date': '2006-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Relapse', 'timeFrame': 'Day 1 to relapse', 'description': 'Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.'}, {'measure': 'Time in Remission', 'timeFrame': 'Day 1 to last PANSS measurement', 'description': 'Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Relapse', 'Remission', 'Treatment Outcome', 'long-acting injectable'], 'conditions': ['Schizophrenia', 'Psychotic Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness of two antipsychotic medications, Risperdal® Consta® versus Abilify®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.', 'detailedDescription': "Although many patients with schizophrenia currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations of antipsychotics may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. The purpose of this trial is to evaluate the long-term effectiveness of Risperdal® Consta®, a long-acting injectable antipsychotic medication, versus Abilify®, an oral antipsychotic medication in patients with schizophrenia. The study will include patients, who in the investigator's opinion may benefit from a change in their current antipsychotic medication due to insufficient effectiveness, side effects or difficulty in adhering to a daily dose regimen. This is an open-label, randomized study in which patients will have an equal chance of receiving treatment for up to 2 years with Risperdal® Consta®, administered in the muscles near the hip every 2 weeks, or Abilify®, taken orally once daily. The initial dose and subsequent dose of study drug will be determined by the investigator. The patient's current oral antipsychotic medication will be decreased over the first four weeks of the study and discontinued. During the study, investigators may adjust the dose of study drug or add new antipsychotic medications to treat worsening psychotic symptoms. Patients may continue on or have added, antidepressants, mood stabilizers (except carbamazepine), sedative hypnotics, or anxiolytic medications during the study. Patients will return to the doctor's office every two weeks to receive an injection of Risperdal® Consta® or another supply of Abilify®. During certain visits, patients will be asked questions which will help the investigator determine the severity of the patient's illness, how well the study drug is working, quality of life, reasoning, memory, judgement and perception and side effects that may be associated with schizophrenia or treatment. Safety evaluations include the incidence of adverse events during the study, vital signs and clinical laboratory tests (both blood and urine). The study hypothesis is that Risperdal® Consta® is superior to Abilify® in the long-term treatment of subjects with schizophrenia as measured by time to relapse and time in remission. Treatment with Risperdal® Consta® (administered in the muscle every 2 weeks) at a dose of 25, 37.5 or 50 mg or Abilify® (administered orally daily) at a dose of 10-30 mg for 2 years. Investigators will determine the starting dose and may adjust the dosage of study drug during the study according to symptoms and treatment response."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with diagnosis of schizophrenia\n* Patient has had at least 2 psychotic relapses in the two years prior to study entry\n* patient is not adequately benefiting from their current antipsychotic medication\n\nExclusion Criteria:\n\n* Patients that have been hospitalized or had major medication changes within 2 months of study entry\n* Patients currently experiencing, or who have experienced worsening of disease symptoms within 2 months of study entry\n* Patients currently using clozapine or carbamazepine\n* Patients who have undergone electroconvulsive therapy or depot antipsychotic treatment within 6 months prior to study entry\n* pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00299702', 'briefTitle': 'Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}, 'officialTitle': 'A 2-year, Prospective, Blinded-rater, Open-label, Active-controlled, Multicenter, Randomized Study of Long-term Efficacy and Effectiveness Comparing Risperdal® Consta® and Abilify® (Aripiprazole) in Adults With Schizophrenia', 'orgStudyIdInfo': {'id': 'CR006121'}, 'secondaryIdInfos': [{'id': 'RISSCH4060', 'type': 'OTHER', 'domain': 'Johnson & Johnson Pharmaceutical Research and Development, L.L.C.'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '002', 'interventionNames': ['Drug: Abilify']}, {'type': 'EXPERIMENTAL', 'label': '001', 'interventionNames': ['Drug: Risperidal Consta']}], 'interventions': [{'name': 'Abilify', 'type': 'DRUG', 'description': '10-30 mg once daily for 104 weeks', 'armGroupLabels': ['002']}, {'name': 'Risperidal Consta', 'type': 'DRUG', 'description': '25mg, 37.5mg, or 50mg every 2 weeks for 104 weeks', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Janssen, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Vice President, Medical Affairs', 'oldOrganization': 'Ortho-McNeil Janssen Scientific Affairs, LLC'}}}}