Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT00257166
Status:
COMPLETED
Last Update Posted:
2021-03-03
First Post:
2005-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
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.gov_Inquiries@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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Ziprasidone', 'description': "Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to \\[\\>=\\] 45 kilogram \\[kg\\] weight and ziprasidone 60 to 80 mg/day for participants with less than \\[\\<\\] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with \\>= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with \\<45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.", 'otherNumAtRisk': 149, 'otherNumAffected': 128, 'seriousNumAtRisk': 149, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo matched to ziprasidone capsule orally twice daily up to Week 4.', 'otherNumAtRisk': 88, 'otherNumAffected': 42, 'seriousNumAtRisk': 88, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypersexuality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 149, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': "Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to \\[\\>=\\] 45 kilogram \\[kg\\] weight and ziprasidone 60 to 80 mg/day for participants with less than \\[\\<\\] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with \\>= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with \\<45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to ziprasidone capsule orally twice daily up to Week 4.'}], 'classes': [{'title': 'Baseline (n=143,86)', 'categories': [{'measurements': [{'value': '26.2', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '27.0', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=97,51)', 'categories': [{'measurements': [{'value': '-13.8', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '-9.9', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.22', 'ciLowerLimit': '-8.12', 'ciUpperLimit': '-2.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.48', 'groupDescription': 'Change at Week 4: Mixed effects repeated measures Analysis of Covariance (ANCOVA) model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4', 'description': 'YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT): all randomized participants who had baseline measurements, took at least (\\>=) 1 dose of study medication (ziprasidone or placebo) and had \\>=1 post-baseline visit. Here, 'n' signifies those participants who were available for this measure at given time points for each group."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': "Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to \\[\\>=\\] 45 kilogram \\[kg\\] weight and ziprasidone 60 to 80 mg/day for participants with less than \\[\\<\\] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with \\>= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with \\<45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to ziprasidone capsule orally twice daily up to Week 4.'}], 'classes': [{'title': 'Change at Week 1 (n=131,85)', 'categories': [{'measurements': [{'value': '-9.3', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=120,81)', 'categories': [{'measurements': [{'value': '-11.5', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '-8.1', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=108,65)', 'categories': [{'measurements': [{'value': '-13.0', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '7.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2545', 'ciLowerLimit': '-5.1045', 'ciUpperLimit': '-1.4046', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.9422', 'groupDescription': 'Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0117', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.5857', 'ciLowerLimit': '-6.3705', 'ciUpperLimit': '-0.8009', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4184', 'groupDescription': 'Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.8665', 'ciLowerLimit': '-8.2345', 'ciUpperLimit': '-1.4985', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.7154', 'groupDescription': 'Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3', 'description': 'YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. 'N' (number of participants analyzed) signifies those participants who were available for this measure. 'n' signifies those participants who were available for this measure at given time points for each group respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': "Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to \\[\\>=\\] 45 kilogram \\[kg\\] weight and ziprasidone 60 to 80 mg/day for participants with less than \\[\\<\\] 45 kg weight over 2 weeks, as per investigator's discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with \\>= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with \\<45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matched to ziprasidone capsule orally twice daily up to Week 4.'}], 'classes': [{'title': 'Baseline (n=143,86)', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 1 (n=131,85)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 2 (n=120,82)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 3 (n=108,65)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 4 (n=96,51)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3754', 'ciLowerLimit': '-0.5696', 'ciUpperLimit': '-0.1812', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0989', 'groupDescription': 'Change at Week 1: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5596', 'ciLowerLimit': '-0.8256', 'ciUpperLimit': '-0.2936', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1355', 'groupDescription': 'Change at Week 2: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6798', 'ciLowerLimit': '-1.0024', 'ciUpperLimit': '-0.3572', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1643', 'groupDescription': 'Change at Week 3: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6884', 'ciLowerLimit': '-1.0342', 'ciUpperLimit': '-0.3426', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1761', 'groupDescription': 'Change at Week 4: Mixed effects repeated measures ANCOVA model with center and participant within center as random effects, treatment, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate was used for the analysis.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 2, 3, 4', 'description': "CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population. Here, 'n' signifies those participants who were available for this measure at given time points for each group respectively."}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Improvement (CGI-I) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': "Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to \\[\\>=\\] 45 kilogram \\[kg\\] weight and ziprasidone 60 to 80 mg/day for participants with less than \\[\\<\\] 45 kg weight over 2 weeks, as per investigator's discretion. 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Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with \\>= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with \\<45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion."}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo matched to ziprasidone capsule orally twice daily up to Week 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '10 to 13 years', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': '14 to 17 years', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': '>=18 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '131', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2005-11-21', 'resultsFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2005-11-21', 'lastUpdatePostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-05-24', 'studyFirstPostDateStruct': {'date': '2005-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4', 'timeFrame': 'Baseline, Week 4', 'description': 'YMRS: an 11-item scale that measured the severity of manic episodes. 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YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.'}, {'measure': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4', 'timeFrame': 'Baseline, Week 1, 2, 3, 4', 'description': "CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill)."}, {'measure': 'Clinical Global Impression - Improvement (CGI-I) Score', 'timeFrame': 'Week 1, 2, 3, 4', 'description': 'CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.'}]}, 'conditionsModule': {'conditions': ['Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '24111980', 'type': 'DERIVED', 'citation': 'Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Efficacy, long-term safety, and tolerability of ziprasidone in children and adolescents with bipolar disorder. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):545-57. doi: 10.1089/cap.2012.0029. Epub 2013 Oct 10.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281132&StudyName=Safety%20and%20efficacy%20of%20ziprasidone%20in%20children%20and%20adolescents%20with%20Bipolar%20I%20Disorder%20%28manic%20or%20mixed%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years\n\nExclusion Criteria:\n\n* Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical 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