Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-02 @ 12:59 PM
Study NCT ID:
NCT00280566
Status:
COMPLETED
Last Update Posted:
2021-03-25
First Post:
2006-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, '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 info other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This is a maintenance of effect design using a survival analysis methodology. In such a design it may be difficult to interpret timepoint by timepoint treatment group comparisons in MRS, CGI-S, CGI-I, MADRS, and PANSS.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Period 1 Open Label Ziprasidone', 'description': '40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.', 'otherNumAffected': 362, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Ziprasidone', 'description': 'Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.', 'otherNumAffected': 22, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2', 'otherNumAffected': 24, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 134}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v 11.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Affect lability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bipolar disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric decompensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 584, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 112, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Intervention for a Mood Episode During Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'categories': [{'measurements': [{'value': '172.159', 'spread': '5.646', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '201'}, {'value': '143.133', 'spread': '7.532', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0104', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Equality of Survival Curves across the treatment groups.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'alpha = 0.05 level of significance'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: 24 weeks or time of early termination', 'description': 'Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT):Subjects took at least 1 dose double blind medication and had at least 1 post randomization observation. Double Blind Period followed at least 8 weeks open-label ziprasidone plus mood stabilizer; 25 out of 127 and 36 out of 111 subjects had an intervention for a mood episode.'}, {'type': 'SECONDARY', 'title': 'Time to Discontinuation for Any Reason During Double Blind Period 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'categories': [{'measurements': [{'value': '153.526', 'spread': '6.454', 'groupId': 'OG000'}, {'value': '123.313', 'spread': '7.524', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0047', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'alpha = 0.05 level of significance', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'No adjustment made for multiple comparisons'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: 24 weeks or time of early termination', 'description': 'Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT). Number of participants who discontinued was 43 and 57 for ziprasidone and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Modified Time to Intervention for a Mood Episode (TIME)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'categories': [{'measurements': [{'value': '168.145', 'spread': '5.857', 'groupId': 'OG000'}, {'value': '140.325', 'spread': '7.627', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0205', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustment made for multiple comparisons', 'groupDescription': 'alpha = 0.05 level of significance', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Week 24 or time of early termination', 'description': 'Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT). 29 out of 127 ziprasidone subjects and 38 out of 111 placebo subjects met the modified criteria for an intervention for a mood episode'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'title': 'Week 1 (n=121, 106)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=116, 95)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=117,95)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=107, 79)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=98, 70)', 'categories': [{'measurements': [{'value': '-1.0', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=94,65)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=84, 58)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=85,53)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1247', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.55', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 1: Difference in Change during Period 2 MMRM ANCOVA: center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.7515', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance'}, {'pValue': '0.3074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.62', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance'}, {'pValue': '0.0758', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-1.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.71', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0162', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-1.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.82', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-3.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.83', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance'}, {'pValue': '0.0242', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-2.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.98', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-1.71', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.71', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Weeks 1 - 24 or time of early termination', 'description': 'Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'title': 'Week 1 (n=122, 106)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=117, 95)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=117, 95)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=107, 79)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=98, 70)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=94, 65)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=83, 58)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=85, 53)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0088', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.3677', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.11', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.10', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.9166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.2791', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.14', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.1460', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.7301', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.8162', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Weeks 1 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'title': 'Week 1 (n=122, 106)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=117, 95)', 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=117, 95', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=107, 79)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=98, 70)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=94, 65)', 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=83, 58)', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=85, 53)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0013', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.1167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.17', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.3413', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.2760', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.16', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0085', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.1317', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.27', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.1666', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Weeks 1 - 24 or time of early termination', 'description': "Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse.", 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'title': 'Week 1 (n=121, 106)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=117, 95)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=117, 95)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=107, 79)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '5.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=98, 70)', 'categories': [{'measurements': [{'value': '1.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=94,65)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=84, 58)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=85, 53)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-2.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.75', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 1 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.1412', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-1.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.91', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 2 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0861', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-1.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.87', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.5992', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.82', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.5873', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.41', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.76', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.2116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.97', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.78', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.1847', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.68', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.9972', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.00', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.82', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Weeks 1 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'title': 'Week 4 (n=123, 98)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=107, 79)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=98, 70)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=94, 65)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=84, 58)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=85, 53)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5954', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.93', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.3414', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.89', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.93', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.9745', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.23', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.5627', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.85', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.47', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.7410', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.10', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.9632', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.88', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Weeks 4 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Randomized to Double Blind Therapy with Placebo plus mood stabilizer'}], 'classes': [{'title': 'Week 4 (n=123, 98)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8 (n=107, 79)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=98, 70)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 16 (n=94, 65)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 20 (n=84, 58)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 (n=85, 53)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9538', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 4 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.8541', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.25', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.1084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.52', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0380', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.56', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.2649', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.2394', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '-0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.27', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Weeks 4 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. 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treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.0443', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.51', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 8 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.3039', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 12 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.9953', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.00', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '0.46', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 16 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.1653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.44', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 20 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}, {'pValue': '0.5771', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '0.18', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.32', 'estimateComment': 'Mean Difference (Final Values) = Least Squares Mean', 'groupDescription': 'Week 24 mixed effects repeated measures analysis of covariance (MMRM ANCOVA): center, subject within center as random effects; treatment, visit, visit by treatment interaction as fixed effects and baseline score as covariate.', 'statisticalMethod': 'MMRM ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'MMRM ANCOVA = mixed effects repeated measures analysis of covariance.'}], 'paramType': 'MEAN', 'timeFrame': 'Period 2: Weeks 4 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).', 'unitOfMeasure': 'scores on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intent to treat (ITT); (n) = number of subjects with analyzable data at observation for ziprasidone and placebo, respectively.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Period 1 Open Label Ziprasidone', 'description': '40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.'}, {'id': 'FG001', 'title': 'Ziprasidone', 'description': 'Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2'}], 'periods': [{'title': 'Period 1 Open Label Ziprasidone', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 subject inappropriately randomized into 2 different sites. Data from this subject was excluded.', 'groupId': 'FG000', 'numSubjects': '584'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Subject excluded as described above is counted as 2; enrolled in 2 sites (2 identification numbers)', 'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '343'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Laboratory Abnormality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2 Double Blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 subject in Period 1 did not want to be randomized into Period 2', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '54'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '57'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'Laboratory Abnormality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Trial intended to be outpatient trial. Patients hospitalized at the screening visit due to disease under study were to be stable enough for outpatient status within approximately 5 days.', 'preAssignmentDetails': 'Period 1:open label stabilization (ziprasidone plus lithium or valproic acid mood stabilizer). Period 2:subjects stabilized for 8 weeks randomized to blinded treatment (ziprasidone plus mood stabilizer or placebo plus mood stabilizer). 241 completed Period 1, 238 summarized in Period 2: 1 subject not randomized to Period 2, 2 excluded as per note.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ziprasidone', 'description': 'Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.6', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '38.0', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '38.4', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}], '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': 584}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2006-01-19', 'resultsFirstSubmitDate': '2009-05-06', 'studyFirstSubmitQcDate': '2006-01-19', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-11-11', 'studyFirstPostDateStruct': {'date': '2006-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Intervention for a Mood Episode During Double Blind Period', 'timeFrame': 'Period 2: 24 weeks or time of early termination', 'description': 'Time to Intervention for Mood Episode (TIME) while on randomized drug after at least 8 weeks of symptom reduction on open-label ziprasidone plus mood stabilizer. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.'}], 'secondaryOutcomes': [{'measure': 'Time to Discontinuation for Any Reason During Double Blind Period 2', 'timeFrame': 'Period 2: 24 weeks or time of early termination', 'description': 'Key Secondary endpoint is time to discontinuation for any reason. Profile of patients remaining in the trial over time.'}, {'measure': 'Modified Time to Intervention for a Mood Episode (TIME)', 'timeFrame': 'Period 2: Week 24 or time of early termination', 'description': 'Time to intervention for a mood episode or time to discontinuation for treatment related adverse events, or death due to drug, or death due to disease. Mood episode considered to have occurred and subject discontinued if one or more of the following: Investigator (INV) decides discontinuation is in best interest of subject; loss of effect and/or change to treatment regimen (INV judgment); subject hospitalized for disease under study; Mania Rating Scale (MRS) and/or Montgomery-Asberg Rating Scale (MADRS) rating is ≥18 for 2 consecutive visits scheduled no more than 10 days apart.'}, {'measure': 'Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period', 'timeFrame': 'Period 2: Weeks 1 - 24 or time of early termination', 'description': 'Period 2 Baseline = last observation in Period 1 to the start of Period 2. MRS is 11-item scale to measure mania; derived from Schedule for Affective Disorders and Schizophrenia-Change Behavior (SADS-CB). Subscales: Manic Syndrome (elevated mood, less need for sleep, excessive energy and activity, grandiosity), Behavior and Ideation (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment), and Impaired Insight. Racing thoughts range=0 to 2 (highest level of abnormal=2); all other items 0 to 5 (highest level of abnormal=5). Higher score = greater abnormality.'}, {'measure': 'Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period', 'timeFrame': 'Period 2: Weeks 1 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Clinical Global Impression Severity Score is 7-item scale rates severity of illness from 0=not assessed, 1= normal to 7=most extremely ill.'}, {'measure': 'Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period', 'timeFrame': 'Period 2: Weeks 1 - 24 or time of early termination', 'description': "Clinical Global Impression measures 7 items in Global assessment of improvement in patient's condition; 0=not assessed, 1= very much improved to 7= very much worse."}, {'measure': 'Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period', 'timeFrame': 'Period 2: Weeks 1 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. MADRS is 10-item instrument measuring depression: scales from 0=Normal to 6 = most abnormal.'}, {'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period', 'timeFrame': 'Period 2: Weeks 4 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive and Negative Syndrome Scale Total Score is 30-item scale measuring severity of psychopathology (16 items), positive symptoms (7 items) and negative symptoms (7 items); scale from 1 (absent) to 7 (extreme)'}, {'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period', 'timeFrame': 'Period 2: Weeks 4 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Positive Scale is 7-items derived from PANSS; 1 (absent), 2 (minimal) to 7 (extreme).'}, {'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period', 'timeFrame': 'Period 2: Weeks 4 - 24 or time of early termination', 'description': 'Baseline for Period 2 is the last observation in Period 1 to the start of Period 2. Negative Scale is 7 items derived from PANSS; scale is 1 (absent) to 7 (extreme).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bipolar Mania', 'Bipolar Disorder']}, 'referencesModule': {'references': [{'pmid': '20122373', 'type': 'DERIVED', 'citation': 'Bowden CL, Vieta E, Ice KS, Schwartz JH, Wang PP, Versavel M. Ziprasidone plus a mood stabilizer in subjects with bipolar I disorder: a 6-month, randomized, placebo-controlled, double-blind trial. J Clin Psychiatry. 2010 Feb;71(2):130-7. doi: 10.4088/JCP.09m05482yel. Epub 2010 Jan 26.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281137&StudyName=Safety%20and%20Maintenance%20of%20Effect%20of%20Ziprasidone%20Plus%20a%20Mood%20Stabilizer%20in%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 ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)\n\nExclusion Criteria:\n\nUltra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome'}, 'identificationModule': {'nctId': 'NCT00280566', 'briefTitle': 'Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents', 'orgStudyIdInfo': {'id': 'A1281137'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ziprasidone', 'description': 'Active treatment, double-blind, randomized arm', 'interventionNames': ['Drug: Ziprasidone Oral Capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo treatment, double-blind, randomized arm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.', 'armGroupLabels': ['Placebo']}, {'name': 'Ziprasidone Oral Capsule', 'type': 'DRUG', 'otherNames': ['Geodon, Zeldox'], 'description': 'Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.', 'armGroupLabels': ['Ziprasidone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35226', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35924', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85251', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 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