Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT00312494
Status:
COMPLETED
Last Update Posted:
2021-03-29
First Post:
2006-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092292', 'term': 'ziprasidone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.govCallCenter@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of \\< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \\< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population: all randomized subjects who were administered at least 1 dose of double-blind medication; includes data from the 2 sites that were closed due to GCP deviations.', 'eventGroups': [{'id': 'EG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer', 'otherNumAtRisk': 223, 'otherNumAffected': 134, 'seriousNumAtRisk': 223, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer', 'otherNumAtRisk': 216, 'otherNumAffected': 99, 'seriousNumAtRisk': 216, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer', 'otherNumAtRisk': 217, 'otherNumAffected': 82, 'seriousNumAtRisk': 217, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Anterograde amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Acute psychosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Emotional disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 223, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.19', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-10.95', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '-9.47', 'spread': '0.83', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1077', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': "The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.", 'groupDescription': 'N=135/arm (405 total) for 85% power for 2-sample t-test (2-sided alpha=0.05) based on true mean difference=3.5 and SD=10. Interim Analysis (IA) to validate sample-size assumptions and adjust sample-size if needed. Based on IA results total sample-size increased to N=223/arm (669 total) to maintain desired power. Null Hypothesis=No statistically significant difference between add-on ziprasidone (higher, lower dose) and add-on placebo groups with respect to the population mean for primary endpoint', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4274', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': "The p-values reported are unadjusted for multiple comparisons. Dunnet's procedure for multiple dose comparisons to placebo was used for primary efficacy measure at Week 3.", 'groupDescription': 'Week 3 Mixed Model Repeated Measures (MMRM) with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score. Tests were 2-sided and performed at the 0.05 significance level.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 3', 'description': 'YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \\[rate and amount\\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat population (ITT): all randomized subjects who received at least 1 dose of double-blind medication, who had 1 baseline and at least 1 post-baseline primary efficacy evaluation; excluding data from 2 sites that were closed due to Good Clinical Practices (GCP) deviations.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 1 and Week 2 in YMRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'classes': [{'title': 'Week 1 (n=202, 205, 200)', 'categories': [{'measurements': [{'value': '-4.38', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-4.56', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '-5.10', 'spread': '0.70', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=178, 188, 186)', 'categories': [{'measurements': [{'value': '-7.10', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-7.56', 'spread': '0.73', 'groupId': 'OG001'}, {'value': '-8.24', 'spread': '0.76', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4025', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2830', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4125', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1527', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline YMRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 1, Week 2', 'description': 'YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \\[rate and amount\\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population excluding data from 2 sites that were closed to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'classes': [{'title': 'Week 1 (n=202, 205, 200)', 'categories': [{'measurements': [{'value': '-2.16', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-2.47', 'spread': '0.49', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '0.63', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=178, 188, 186)', 'categories': [{'measurements': [{'value': '-3.27', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-3.24', 'spread': '0.55', 'groupId': 'OG001'}, {'value': '-1.71', 'spread': '0.66', 'groupId': 'OG002'}]}]}, {'title': 'Week 3 (n=163, 172, 170)', 'categories': [{'measurements': [{'value': '-4.20', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '0.64', 'groupId': 'OG001'}, {'value': '-2.90', 'spread': '0.70', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0101', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0694', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0183', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons', 'groupDescription': 'Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0176', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons', 'groupDescription': 'Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2302', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0796', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline MADRS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'classes': [{'title': 'Week 1 (n=202, 206, 200)', 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '0.07', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=178, 188, 186)', 'categories': [{'measurements': [{'value': '-0.70', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.74', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.73', 'spread': '0.09', 'groupId': 'OG002'}]}]}, {'title': 'Week 3 (n=163, 172, 171)', 'categories': [{'measurements': [{'value': '-0.94', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6191', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5629', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.9049', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7153', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2420', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6121', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline as covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Improvement (CGI-I) Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'classes': [{'title': 'Week 1 (n=202, 206, 200)', 'categories': [{'measurements': [{'value': '3.34', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '3.34', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '3.38', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Week 2 (n=178, 188, 186)', 'categories': [{'measurements': [{'value': '3.02', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '2.98', 'spread': '0.10', 'groupId': 'OG002'}]}]}, {'title': 'Week 3 (n=163, 172, 171)', 'categories': [{'measurements': [{'value': '2.65', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '2.72', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6138', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.6536', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 1 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4758', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.7581', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 2 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2221', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.5665', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, and treatment by visit interaction.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': "CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected.", 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'classes': [{'title': 'Week 3 total score (n=198, 199, 189)', 'categories': [{'measurements': [{'value': '-4.87', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '-5.34', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '-3.44', 'spread': '1.84', 'groupId': 'OG002'}]}]}, {'title': 'Week 3 positive score (n=198, 199, 189)', 'categories': [{'measurements': [{'value': '-1.94', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '-2.26', 'spread': '0.52', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '0.56', 'groupId': 'OG002'}]}]}, {'title': 'Week 3 negative score (n=198, 199, 189)', 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '0.52', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1063', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2499', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 total score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0876', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3623', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 positive score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS positive score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4686', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2202', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 negative score MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline PANSS negative score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 3', 'description': 'PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population excluding data from 2 sites that were closed due to GCP deviations; (n)=number of subjects for ziprasidone (higher dose), ziprasidone (lower dose), and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Assessment of Functioning (GAF) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'classes': [{'categories': [{'measurements': [{'value': '8.79', 'spread': '1.23', 'groupId': 'OG000'}, {'value': '9.62', 'spread': '1.25', 'groupId': 'OG001'}, {'value': '7.79', 'spread': '1.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0728', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3174', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline GAF score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 3', 'description': 'GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population excluding data from 2 sites that were closed due to GCP deviations.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '210', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.68', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '-1.27', 'spread': '0.46', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4460', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.3253', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The p-values reported are unadjusted for multiple comparisons.', 'groupDescription': 'Week 3 MMRM with model terms: treatment, length of prior lithium/divalproex usage, type of mood stabilizer therapy, rapid cycling, hospitalization status, visit, treatment by visit interaction, and baseline LIFE-RIFT total score.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 3', 'description': 'LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population excluding data from 2 sites that were closed due to GCP deviations.'}, {'type': 'SECONDARY', 'title': 'Anonymized Pharmacogenomic Blood Draw', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'OG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'timeFrame': 'Baseline', 'description': 'Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects eligible (optional consent); samples were not to be analyzed as part of the current protocol and the analysis was not to be covered by the statistical analysis plan.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'FG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '226'}, {'groupId': 'FG002', 'numSubjects': '222'}]}, {'type': 'Received Study Treatment', 'achievements': [{'comment': '1 subject randomized to higher dose; received lower dose at baseline, higher dose weeks 1 and 2.', 'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '216'}, {'groupId': 'FG002', 'numSubjects': '217'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '1 subject randomized to higher dose; received lower dose baseline and/or week 1; higher dose week 2.', 'groupId': 'FG000', 'numSubjects': '161'}, {'groupId': 'FG001', 'numSubjects': '168'}, {'groupId': 'FG002', 'numSubjects': '179'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '43'}]}], 'dropWithdraws': [{'type': 'Randomized; not treated with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Laboratory abnormality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}, {'value': '656', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ziprasidone (Higher Dose)', 'description': 'Ziprasidone 120 to 160 mg daily + Mood Stabilizer'}, {'id': 'BG001', 'title': 'Ziprasidone (Lower Dose)', 'description': 'Ziprasidone 40 to 80 mg daily + Mood Stabilizer'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Between 18 and 44 years', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '375', 'groupId': 'BG003'}]}]}, {'title': 'Between 45 and 64 years', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}, {'value': '278', 'groupId': 'BG003'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}, {'value': '318', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 680}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2006-04-06', 'resultsFirstSubmitDate': '2009-12-17', 'studyFirstSubmitQcDate': '2006-04-06', 'lastUpdatePostDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-12-17', 'studyFirstPostDateStruct': {'date': '2006-04-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 3 in Young Mania Rating Scale (YMRS)', 'timeFrame': 'Baseline, Week 3', 'description': 'YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \\[rate and amount\\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 1 and Week 2 in YMRS', 'timeFrame': 'Baseline, Week 1, Week 2', 'description': 'YMRS is an 11-item scale (elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, speech \\[rate and amount\\], language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight) used to assess the severity of manic symptoms and effect of treatment on mania severity. Seven items ranked on scale from 0 to 4; 4 items ranked 0 to 8. Total possible score 0 to 60: higher scores indicate greater severity. Change calculated as mean of (value of YMRS score at observation minus baseline value).'}, {'measure': 'Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Scores', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts); rated on a 7-point Likert scale 0 (normal) to 6 (most abnormal) with anchors at 2-point intervals; total score 0 to 44 (higher score indicates greater severity of symptoms). Change calculated as mean of (value of MADRS score at observation minus baseline value).'}, {'measure': 'Change From Baseline in Clinical Global Impression Scale - Severity (CGI-S) Score', 'timeFrame': 'Baseline, Week 1, Week 2, Week 3', 'description': 'CGI-S is a single-item clinician rated scale used to assess global severity of bipolar illness based on an overall evaluation of symptoms of bipolar mania, associated behavioral symptoms, and condition of the subject. Rating ranges from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score = more affected. Change calculated as mean of (value of CGI-S score at observation minus baseline value).'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I) Scale Scores', 'timeFrame': 'Week 1, Week 2, Week 3', 'description': "CGI-I is a single-item clinician rated scale used to assess global improvement in the subject's clinical state (bipolar mania) in response to study treatment and as compared to their status at pre-treatment baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score = more affected."}, {'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score', 'timeFrame': 'Baseline, Week 3', 'description': 'PANSS is a 30-item scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Scores rated 1 (absent symptoms) to 7 (extreme); total score range 30 to 210: higher score indicates greater severity. Change calculated as mean of (value of PANSS score at observation minus baseline value).'}, {'measure': 'Change From Baseline in Global Assessment of Functioning (GAF) Score', 'timeFrame': 'Baseline, Week 3', 'description': 'GAF measures the severity of illness-related impairment in psychological, social, and occupational functioning; rated on a 100-point scale (single score of 1 to 100) with 100 indicating superior functioning. Change calculated as mean of (value of GAF score at observation minus baseline value).'}, {'measure': 'Change From Baseline in Longitudinal Interval Follow-up Evaluation Range of Impaired Functioning (LIFE-RIFT) Score', 'timeFrame': 'Baseline, Week 3', 'description': 'LIFE-RIFT measures severity of illness-related impairment in 4 domains: work, interpersonal relations, recreation, and global satisfaction; has a total score and individual domain scores. Domain scores range from 1 to 5 (scores ≥ 2 reflect impaired functioning). Total score is sum of the 4 domains with range of 4 (very good) to 20 (very poor): higher scores indicate greater impairment. Change calculated as mean of (value of LIFE-RIFT score at observation minus baseline value).'}, {'measure': 'Anonymized Pharmacogenomic Blood Draw', 'timeFrame': 'Baseline', 'description': 'Anonymized pharmacogenomic blood draw to evaluate the pharmacogenomic basis for ziprasidone treatment responsivity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '23218158', 'type': 'DERIVED', 'citation': 'Sachs GS, Vanderburg DG, Edman S, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 2: influence of protocol-specific eligibility criteria on signal detection. J Clin Psychiatry. 2012 Nov;73(11):1420-5. doi: 10.4088/JCP.11m07389.'}, {'pmid': '23218157', 'type': 'DERIVED', 'citation': 'Sachs GS, Vanderburg DG, Karayal ON, Kolluri S, Bachinsky M, Cavus I. Adjunctive oral ziprasidone in patients with acute mania treated with lithium or divalproex, part 1: results of a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 Nov;73(11):1412-9. doi: 10.4088/JCP.11m07388.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281143&StudyName=3-week%20study%20to%20evaluate%20efficacy%20and%20safety%20of%20ziprasidone%20with%20either%20lithium%20or%20divalproex%20in%20acutely%20manic%20subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).\n* At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.\n* Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.\n\nExclusion Criteria:\n\n* Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (DSM-IV TR) diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (NOS) (298.9).\n* Subjects with other DSM-IV-TR Axis I or Axis II disorders (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6-month period prior to screening.'}, 'identificationModule': 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