Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-11 @ 3:36 AM
Study NCT ID:
NCT00257192
Status:
TERMINATED
Last Update Posted:
2021-03-25
First Post:
2005-11-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Germany', 'Mexico', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic 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 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}, 'limitationsAndCaveats': {'description': 'The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.'}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.', 'description': 'Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.', 'eventGroups': [{'id': 'EG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.', 'otherNumAtRisk': 193, 'otherNumAffected': 110, 'seriousNumAtRisk': 193, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.', 'otherNumAtRisk': 90, 'otherNumAffected': 27, 'seriousNumAtRisk': 90, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Overdose', 'notes': 'All overdoses were due to clinical or subject error.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Extrapyramidal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hallucination, auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hostility', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Impulsive behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 193, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.16', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-12.35', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1530', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.80', 'ciLowerLimit': '-4.28', 'ciUpperLimit': '0.67', 'pValueComment': 'Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.26', 'groupDescription': 'Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (\\<) 0.0124) or for futility (2-sided p-value greater than (\\>) 0.4772; The final analysis is to employ a 2-sided p-value \\<0.0462.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.05', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.84', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1289', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.06', 'pValueComment': 'Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Difference from placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': "CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at post-baseline observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '-23.58', 'spread': '1.42', 'groupId': 'OG000'}, {'value': '-21.01', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1987', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciPctValue': '95', 'paramValue': '-2.57', 'ciLowerLimit': '-6.50', 'ciUpperLimit': '1.36', 'pValueComment': 'Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.00', 'groupDescription': 'Total score: difference from placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at post-baseline observation.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PANSS: Positive and Negative Subscales at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Positive score', 'categories': [{'measurements': [{'value': '-7.22', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-5.88', 'spread': '0.56', 'groupId': 'OG001'}]}]}, {'title': 'Negative score', 'categories': [{'measurements': [{'value': '-5.51', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-5.09', 'spread': '0.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0412', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.33', 'ciLowerLimit': '-2.61', 'ciUpperLimit': '-0.05', 'pValueComment': 'Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.65', 'groupDescription': 'Positive score: difference from placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.4661', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.43', 'ciLowerLimit': '-1.57', 'ciUpperLimit': '0.72', 'pValueComment': 'Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.58', 'groupDescription': 'Negative score: difference from placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at post-baseline observation.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression of Improvement (CGI-I) Score at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.66', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '2.85', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1820', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.09', 'pValueComment': 'Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'Difference from placebo', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 6', 'description': "CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at post-baseline observation.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Global Assessment Scale (CGAS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Week 2 (n=183, 86)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '8.7', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '5.9'}, {'value': '2.6', 'spread': '5.8', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '3.8'}]}]}, {'title': 'Week 4 (n=155, 63)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '10.4', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '9.5'}, {'value': '6.2', 'spread': '8.9', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '8.5'}]}]}, {'title': 'Week 6 (n=135, 52)', 'categories': [{'measurements': [{'value': '10.9', 'spread': '11.8', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '12.9'}, {'value': '10.8', 'spread': '9.9', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '13.5'}]}]}, {'title': 'ET (n=20, 15)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '10.1', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '6.0'}, {'value': '1.7', 'spread': '8.9', 'groupId': 'OG001', 'lowerLimit': '-3.2', 'upperLimit': '6.6'}]}]}, {'title': 'Week 6 [LOCF] (n=185, 87)', 'categories': [{'measurements': [{'value': '8.4', 'spread': '11.8', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '10.2'}, {'value': '6.4', 'spread': '10.6', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '8.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Early termination (ET)', 'description': 'CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward \\[LOCF\\] imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Child Health Questionnaire (CHQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Global health: Week 6', 'categories': [{'measurements': [{'value': '5.0', 'spread': '18.2', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '8.1'}, {'value': '8.5', 'spread': '24.7', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '15.5'}]}]}, {'title': 'Global health: ET', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '24.0', 'groupId': 'OG000', 'lowerLimit': '-13.5', 'upperLimit': '2.7'}, {'value': '-9.1', 'spread': '17.4', 'groupId': 'OG001', 'lowerLimit': '-15.3', 'upperLimit': '-2.8'}]}]}, {'title': 'Global health: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '2.8', 'spread': '19.9', 'groupId': 'OG000', 'lowerLimit': '-0.1', 'upperLimit': '5.8'}, {'value': '1.4', 'spread': '23.7', 'groupId': 'OG001', 'lowerLimit': '-3.9', 'upperLimit': '6.6'}]}]}, {'title': 'Global behavior: Week 6', 'categories': [{'measurements': [{'value': '9.4', 'spread': '23.6', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '13.4'}, {'value': '10.9', 'spread': '22.1', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '17.2'}]}]}, {'title': 'Global behavior: ET', 'categories': [{'measurements': [{'value': '6.4', 'spread': '21.4', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '13.6'}, {'value': '-0.5', 'spread': '23.0', 'groupId': 'OG001', 'lowerLimit': '-8.8', 'upperLimit': '7.8'}]}]}, {'title': 'Global behavior: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '8.8', 'spread': '23.1', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '12.3'}, {'value': '6.5', 'spread': '23.1', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '11.7'}]}]}, {'title': 'Family cohesion: Week 6', 'categories': [{'measurements': [{'value': '1.9', 'spread': '21.3', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '5.6'}, {'value': '-0.8', 'spread': '19.7', 'groupId': 'OG001', 'lowerLimit': '-6.4', 'upperLimit': '4.8'}]}]}, {'title': 'Family cohesion: ET', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '18.4', 'groupId': 'OG000', 'lowerLimit': '-8.0', 'upperLimit': '4.4'}, {'value': '-2.6', 'spread': '16.1', 'groupId': 'OG001', 'lowerLimit': '-8.5', 'upperLimit': '3.3'}]}]}, {'title': 'Family cohesion: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '1.2', 'spread': '20.8', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '4.3'}, {'value': '-1.1', 'spread': '18.1', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '2.9'}]}]}, {'title': 'Physical health: Week 6', 'categories': [{'measurements': [{'value': '3.5', 'spread': '33.9', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '9.3'}, {'value': '5.0', 'spread': '28.0', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '13.0'}]}]}, {'title': 'Physical health: ET', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '32.9', 'groupId': 'OG000', 'lowerLimit': '-17.6', 'upperLimit': '4.7'}, {'value': '3.2', 'spread': '23.3', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '11.8'}]}]}, {'title': 'Physical health: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '1.4', 'spread': '33.8', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '6.5'}, {'value': '4.8', 'spread': '26.0', 'groupId': 'OG001', 'lowerLimit': '-1.0', 'upperLimit': '10.6'}]}]}, {'title': 'Bodily pain: Week 6', 'categories': [{'measurements': [{'value': '4.4', 'spread': '21.6', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '8.1'}, {'value': '8.0', 'spread': '19.4', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '13.5'}]}]}, {'title': 'Bodily pain: ET', 'categories': [{'measurements': [{'value': '4.7', 'spread': '23.0', 'groupId': 'OG000', 'lowerLimit': '-3.1', 'upperLimit': '12.5'}, {'value': '0.0', 'spread': '14.6', 'groupId': 'OG001', 'lowerLimit': '-5.3', 'upperLimit': '5.3'}]}]}, {'title': 'Bodily pain: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '4.5', 'spread': '21.9', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '7.8'}, {'value': '4.9', 'spread': '18.1', 'groupId': 'OG001', 'lowerLimit': '0.9', 'upperLimit': '8.9'}]}]}, {'title': 'Emotion, behavior: Week 6', 'categories': [{'measurements': [{'value': '16.2', 'spread': '29.8', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '21.3'}, {'value': '13.8', 'spread': '31.1', 'groupId': 'OG001', 'lowerLimit': '4.9', 'upperLimit': '22.6'}]}]}, {'title': 'Emotion, behavior: ET', 'categories': [{'measurements': [{'value': '4.0', 'spread': '43.1', 'groupId': 'OG000', 'lowerLimit': '-10.6', 'upperLimit': '18.6'}, {'value': '-2.5', 'spread': '22.7', 'groupId': 'OG001', 'lowerLimit': '-10.8', 'upperLimit': '5.8'}]}]}, {'title': 'Emotion, behavior: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '13.6', 'spread': '33.4', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '18.6'}, {'value': '7.8', 'spread': '29.2', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '14.3'}]}]}, {'title': 'Time impact on parent: Week 6', 'categories': [{'measurements': [{'value': '8.8', 'spread': '25.4', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '13.1'}, {'value': '11.8', 'spread': '23.1', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '18.4'}]}]}, {'title': 'Time impact on parent: ET', 'categories': [{'measurements': [{'value': '2.0', 'spread': '25.8', 'groupId': 'OG000', 'lowerLimit': '-6.7', 'upperLimit': '10.7'}, {'value': '1.8', 'spread': '21.7', 'groupId': 'OG001', 'lowerLimit': '-6.2', 'upperLimit': '9.7'}]}]}, {'title': 'Time impact on parent: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '7.4', 'spread': '25.5', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '11.2'}, {'value': '8.0', 'spread': '23.1', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '13.2'}]}]}, {'title': 'Emotional impact on parent: Week 6', 'categories': [{'measurements': [{'value': '8.9', 'spread': '21.6', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '12.5'}, {'value': '10.0', 'spread': '22.3', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '16.3'}]}]}, {'title': 'Emotional impact on parent: ET', 'categories': [{'measurements': [{'value': '3.5', 'spread': '21.2', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '10.6'}, {'value': '2.7', 'spread': '12.6', 'groupId': 'OG001', 'lowerLimit': '-1.8', 'upperLimit': '7.3'}]}]}, {'title': 'Emotional impact on parent: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '7.7', 'spread': '21.6', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '11.0'}, {'value': '7.4', 'spread': '19.4', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '11.6'}]}]}, {'title': 'Mental health: Week 6', 'categories': [{'measurements': [{'value': '8.1', 'spread': '15.3', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '10.7'}, {'value': '12.6', 'spread': '18.2', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '17.8'}]}]}, {'title': 'Mental health: ET', 'categories': [{'measurements': [{'value': '1.3', 'spread': '17.9', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '7.3'}, {'value': '-0.8', 'spread': '12.0', 'groupId': 'OG001', 'lowerLimit': '-5.2', 'upperLimit': '3.6'}]}]}, {'title': 'Mental health: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '6.7', 'spread': '16.1', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '9.1'}, {'value': '7.5', 'spread': '17.4', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '11.4'}]}]}, {'title': 'Physical function: Week 6', 'categories': [{'measurements': [{'value': '5.6', 'spread': '19.7', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '8.9'}, {'value': '5.9', 'spread': '25.2', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '13.1'}]}]}, {'title': 'Physical function: ET', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '22.5', 'groupId': 'OG000', 'lowerLimit': '-13.0', 'upperLimit': '2.2'}, {'value': '-0.2', 'spread': '17.7', 'groupId': 'OG001', 'lowerLimit': '-6.6', 'upperLimit': '6.2'}]}]}, {'title': 'Physical function: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '3.3', 'spread': '20.8', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '6.4'}, {'value': '3.7', 'spread': '22.8', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '8.7'}]}]}, {'title': 'Behavior scale: Week 6', 'categories': [{'measurements': [{'value': '9.0', 'spread': '17.1', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '11.9'}, {'value': '9.0', 'spread': '16.8', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '13.8'}]}]}, {'title': 'Behavior scale: ET', 'categories': [{'measurements': [{'value': '7.6', 'spread': '15.2', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '12.9'}, {'value': '0.6', 'spread': '17.1', 'groupId': 'OG001', 'lowerLimit': '-5.6', 'upperLimit': '6.7'}]}]}, {'title': 'Behavior scale: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '8.7', 'spread': '16.7', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '11.3'}, {'value': '5.8', 'spread': '17.4', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '9.6'}]}]}, {'title': 'Self-esteem: Week 6', 'categories': [{'measurements': [{'value': '6.0', 'spread': '17.5', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '9.0'}, {'value': '9.0', 'spread': '22.9', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '15.5'}]}]}, {'title': 'Self-esteem: ET', 'categories': [{'measurements': [{'value': '1.0', 'spread': '20.6', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '8.0'}, {'value': '1.3', 'spread': '14.0', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '6.5'}]}]}, {'title': 'Self-esteem: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '5.0', 'spread': '18.2', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '7.7'}, {'value': '6.4', 'spread': '20.2', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '10.9'}]}]}, {'title': 'General health perception: Week 6', 'categories': [{'measurements': [{'value': '1.1', 'spread': '11.6', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '3.1'}, {'value': '3.3', 'spread': '11.7', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '6.7'}]}]}, {'title': 'General health perception: ET', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '12.3', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '2.0'}, {'value': '-0.6', 'spread': '10.8', 'groupId': 'OG001', 'lowerLimit': '-4.5', 'upperLimit': '3.3'}]}]}, {'title': 'General health perception: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '0.4', 'spread': '11.8', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '2.2'}, {'value': '1.8', 'spread': '11.5', 'groupId': 'OG001', 'lowerLimit': '-0.8', 'upperLimit': '4.3'}]}]}, {'title': 'Family activities: Week 6', 'categories': [{'measurements': [{'value': '9.2', 'spread': '22.6', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '13.0'}, {'value': '14.6', 'spread': '22.5', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '21.0'}]}]}, {'title': 'Family activities: ET', 'categories': [{'measurements': [{'value': '1.3', 'spread': '16.8', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '7.1'}, {'value': '-4.6', 'spread': '16.5', 'groupId': 'OG001', 'lowerLimit': '-10.6', 'upperLimit': '1.5'}]}]}, {'title': 'Family activities: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '7.5', 'spread': '21.7', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '10.8'}, {'value': '7.8', 'spread': '22.0', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '12.7'}]}]}, {'title': 'Change in health: Week 6', 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '0.6'}, {'value': '0.6', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '0.9'}]}]}, {'title': 'Change in health: ET', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '-0.1'}, {'value': '-0.1', 'spread': '0.8', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '0.2'}]}]}, {'title': 'Change in health: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.5'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '0.6'}]}]}, {'title': 'Physical health global subscale: Week 6', 'categories': [{'measurements': [{'value': '1.8', 'spread': '9.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.5'}, {'value': '2.4', 'spread': '9.8', 'groupId': 'OG001', 'lowerLimit': '-0.4', 'upperLimit': '5.2'}]}]}, {'title': 'Physical health global subscale: ET', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '11.8', 'groupId': 'OG000', 'lowerLimit': '-6.9', 'upperLimit': '1.3'}, {'value': '0.1', 'spread': '4.4', 'groupId': 'OG001', 'lowerLimit': '-1.5', 'upperLimit': '1.7'}]}]}, {'title': 'Physical health global subscale: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '0.9', 'spread': '10.3', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '2.4'}, {'value': '1.6', 'spread': '8.2', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '3.4'}]}]}, {'title': 'Psychosocial health global subscale: Week 6', 'categories': [{'measurements': [{'value': '6.6', 'spread': '9.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '8.3'}, {'value': '7.7', 'spread': '11.0', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '10.9'}]}]}, {'title': 'Psychosocial health global subscale: ET', 'categories': [{'measurements': [{'value': '3.1', 'spread': '10.4', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '6.6'}, {'value': '0.0', 'spread': '5.7', 'groupId': 'OG001', 'lowerLimit': '-2.0', 'upperLimit': '2.1'}]}]}, {'title': 'Psychosocial health global subscale: Week 6 [LOCF]', 'categories': [{'measurements': [{'value': '5.9', 'spread': '9.8', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '7.4'}, {'value': '4.8', 'spread': '10.0', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '7.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, ET', 'description': "CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Week 1 (n=165, 69)', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '7.1', 'groupId': 'OG000', 'lowerLimit': '-3.53', 'upperLimit': '-1.33'}, {'value': '-1.3', 'spread': '5.8', 'groupId': 'OG001', 'lowerLimit': '-2.72', 'upperLimit': '0.05'}]}]}, {'title': 'Week 2 (n=161, 71)', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '8.0', 'groupId': 'OG000', 'lowerLimit': '-3.79', 'upperLimit': '-1.29'}, {'value': '-1.0', 'spread': '6.2', 'groupId': 'OG001', 'lowerLimit': '-2.42', 'upperLimit': '0.51'}]}]}, {'title': 'Week 3 (n=146, 64)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '6.7', 'groupId': 'OG000', 'lowerLimit': '-4.06', 'upperLimit': '-1.88'}, {'value': '-0.7', 'spread': '5.7', 'groupId': 'OG001', 'lowerLimit': '-2.08', 'upperLimit': '0.77'}]}]}, {'title': 'Week 4 (n=138, 51)', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '7.4', 'groupId': 'OG000', 'lowerLimit': '-3.96', 'upperLimit': '-1.46'}, {'value': '-1.0', 'spread': '6.5', 'groupId': 'OG001', 'lowerLimit': '-2.79', 'upperLimit': '0.87'}]}]}, {'title': 'Week 5 (n=126, 44)', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '7.0', 'groupId': 'OG000', 'lowerLimit': '-4.32', 'upperLimit': '-1.86'}, {'value': '-0.8', 'spread': '8.3', 'groupId': 'OG001', 'lowerLimit': '-3.32', 'upperLimit': '1.73'}]}]}, {'title': 'Week 6 (n=119, 42)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '7.4', 'groupId': 'OG000', 'lowerLimit': '-4.30', 'upperLimit': '-1.62'}, {'value': '-1.9', 'spread': '6.7', 'groupId': 'OG001', 'lowerLimit': '-3.94', 'upperLimit': '0.22'}]}]}, {'title': 'Week 6 [LOCF] (n=167, 71)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '8.2', 'groupId': 'OG000', 'lowerLimit': '-3.58', 'upperLimit': '-1.07'}, {'value': '-0.3', 'spread': '8.8', 'groupId': 'OG001', 'lowerLimit': '-2.37', 'upperLimit': '1.81'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': "CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Week 1 (n=179, 82)', 'categories': [{'measurements': [{'value': '-2.8', 'spread': '6.6', 'groupId': 'OG000', 'lowerLimit': '-3.78', 'upperLimit': '-1.84'}, {'value': '-1.4', 'spread': '5.7', 'groupId': 'OG001', 'lowerLimit': '-2.62', 'upperLimit': '-0.11'}]}]}, {'title': 'Week 2 (n=174, 80)', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '7.3', 'groupId': 'OG000', 'lowerLimit': '-5.24', 'upperLimit': '-3.07'}, {'value': '-2.5', 'spread': '5.6', 'groupId': 'OG001', 'lowerLimit': '-3.73', 'upperLimit': '-1.25'}]}]}, {'title': 'Week 3 (n=157, 69)', 'categories': [{'measurements': [{'value': '-5.5', 'spread': '7.4', 'groupId': 'OG000', 'lowerLimit': '-6.69', 'upperLimit': '-4.35'}, {'value': '-3.2', 'spread': '5.4', 'groupId': 'OG001', 'lowerLimit': '-4.48', 'upperLimit': '-1.90'}]}]}, {'title': 'Week 4 (n=148, 59)', 'categories': [{'measurements': [{'value': '-6.0', 'spread': '7.6', 'groupId': 'OG000', 'lowerLimit': '-7.20', 'upperLimit': '-4.74'}, {'value': '-4.9', 'spread': '6.6', 'groupId': 'OG001', 'lowerLimit': '-6.65', 'upperLimit': '-3.18'}]}]}, {'title': 'Week 5 (n=135, 49)', 'categories': [{'measurements': [{'value': '-7.0', 'spread': '8.5', 'groupId': 'OG000', 'lowerLimit': '-8.47', 'upperLimit': '-5.57'}, {'value': '-5.6', 'spread': '5.9', 'groupId': 'OG001', 'lowerLimit': '-7.30', 'upperLimit': '-3.92'}]}]}, {'title': 'Week 6 (n=126, 47)', 'categories': [{'measurements': [{'value': '-7.9', 'spread': '7.9', 'groupId': 'OG000', 'lowerLimit': '-9.29', 'upperLimit': '-6.52'}, {'value': '-6.5', 'spread': '5.5', 'groupId': 'OG001', 'lowerLimit': '-8.13', 'upperLimit': '-4.89'}]}]}, {'title': 'Week 6 [LOCF] (n=178, 82)', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '8.7', 'groupId': 'OG000', 'lowerLimit': '-7.07', 'upperLimit': '-4.51'}, {'value': '-4.0', 'spread': '7.3', 'groupId': 'OG001', 'lowerLimit': '-5.64', 'upperLimit': '-2.43'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': "CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Week 1 (n=188, 86)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 (n=182, 86)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 3 (n=165, 74)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 (n=154, 63)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 5 (n=141, 54)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=134, 52)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF] (n=189, 87)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': "CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Week 2 (n=38, 15)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 (n=30, 8)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF] (n=39, 15)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 2, Week 6', 'description': "Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Sedation: Week 6 (n=124, 47)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.7', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '0.33'}, {'value': '-0.4', 'spread': '1.8', 'groupId': 'OG001', 'lowerLimit': '-0.98', 'upperLimit': '0.08'}]}]}, {'title': 'Sedation: ET (n=23, 26)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '2.3', 'groupId': 'OG000', 'lowerLimit': '-0.98', 'upperLimit': '0.98'}, {'value': '0.2', 'spread': '1.3', 'groupId': 'OG001', 'lowerLimit': '-0.34', 'upperLimit': '0.73'}]}]}, {'title': 'Sedation: Week 6 [LOCF] (n=147, 72)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.8', 'groupId': 'OG000', 'lowerLimit': '-0.28', 'upperLimit': '0.30'}, {'value': '-0.2', 'spread': '1.7', 'groupId': 'OG001', 'lowerLimit': '-0.63', 'upperLimit': '0.16'}]}]}, {'title': 'Verbal Memory: Week 6 (n=124, 47)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '12.1', 'groupId': 'OG000', 'lowerLimit': '-0.83', 'upperLimit': '3.45'}, {'value': '0.5', 'spread': '14.0', 'groupId': 'OG001', 'lowerLimit': '-3.63', 'upperLimit': '4.59'}]}]}, {'title': 'Verbal Memory: ET (n=24, 25)', 'categories': [{'measurements': [{'value': '-2.3', 'spread': '13.9', 'groupId': 'OG000', 'lowerLimit': '-8.22', 'upperLimit': '3.53'}, {'value': '-2.6', 'spread': '15.1', 'groupId': 'OG001', 'lowerLimit': '-8.80', 'upperLimit': '3.66'}]}]}, {'title': 'Verbal Memory: Week 6 [LOCF] (n=148, 71)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '12.4', 'groupId': 'OG000', 'lowerLimit': '-1.39', 'upperLimit': '2.66'}, {'value': '-0.5', 'spread': '14.4', 'groupId': 'OG001', 'lowerLimit': '-3.95', 'upperLimit': '2.87'}]}]}, {'title': 'Visual Memory: Week 6 (n=124, 46)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '13.3', 'groupId': 'OG000', 'lowerLimit': '-1.89', 'upperLimit': '2.83'}, {'value': '2.0', 'spread': '14.5', 'groupId': 'OG001', 'lowerLimit': '-2.31', 'upperLimit': '6.28'}]}]}, {'title': 'Visual Memory: ET (n=24, 26)', 'categories': [{'measurements': [{'value': '-3.8', 'spread': '10.2', 'groupId': 'OG000', 'lowerLimit': '-8.10', 'upperLimit': '0.48'}, {'value': '0.4', 'spread': '14.2', 'groupId': 'OG001', 'lowerLimit': '-5.28', 'upperLimit': '6.17'}]}]}, {'title': 'Visual Memory: Week 6 [LOCF] (n=148, 71)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '12.9', 'groupId': 'OG000', 'lowerLimit': '-2.46', 'upperLimit': '1.69'}, {'value': '1.2', 'spread': '14.3', 'groupId': 'OG001', 'lowerLimit': '-2.19', 'upperLimit': '4.60'}]}]}, {'title': 'Processing Speed: Week 6 (n=124, 46)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '13.5', 'groupId': 'OG000', 'lowerLimit': '-1.06', 'upperLimit': '3.73'}, {'value': '1.0', 'spread': '12.0', 'groupId': 'OG001', 'lowerLimit': '-2.58', 'upperLimit': '4.53'}]}]}, {'title': 'Processing Speed: ET (n=24, 25)', 'categories': [{'measurements': [{'value': '-10.6', 'spread': '34.5', 'groupId': 'OG000', 'lowerLimit': '-25.14', 'upperLimit': '3.99'}, {'value': '0.5', 'spread': '5.4', 'groupId': 'OG001', 'lowerLimit': '-1.73', 'upperLimit': '2.74'}]}]}, {'title': 'Processing Speed: Week 6 [LOCF] (n=148, 70)', 'categories': [{'measurements': [{'value': '-0.6', 'spread': '18.9', 'groupId': 'OG000', 'lowerLimit': '-3.73', 'upperLimit': '2.45'}, {'value': '0.6', 'spread': '10.1', 'groupId': 'OG001', 'lowerLimit': '-1.76', 'upperLimit': '3.06'}]}]}, {'title': 'Reasoning: Week 6 (n=122, 46)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '12.0', 'groupId': 'OG000', 'lowerLimit': '0.09', 'upperLimit': '4.41'}, {'value': '-0.7', 'spread': '14.6', 'groupId': 'OG001', 'lowerLimit': '-5.03', 'upperLimit': '3.65'}]}]}, {'title': 'Reasoning: ET (n=23, 25)', 'categories': [{'measurements': [{'value': '1.3', 'spread': '15.8', 'groupId': 'OG000', 'lowerLimit': '-5.56', 'upperLimit': '8.12'}, {'value': '3.3', 'spread': '14.0', 'groupId': 'OG001', 'lowerLimit': '-2.47', 'upperLimit': '9.13'}]}]}, {'title': 'Reasoning: Week 6 [LOCF] (n=145, 70)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '12.7', 'groupId': 'OG000', 'lowerLimit': '-0.16', 'upperLimit': '4.03'}, {'value': '0.7', 'spread': '14.1', 'groupId': 'OG001', 'lowerLimit': '-2.66', 'upperLimit': '4.06'}]}]}, {'title': 'Executive Functioning: Week 6 (n=123, 46)', 'categories': [{'measurements': [{'value': '2.9', 'spread': '15.4', 'groupId': 'OG000', 'lowerLimit': '0.19', 'upperLimit': '5.68'}, {'value': '2.7', 'spread': '18.2', 'groupId': 'OG001', 'lowerLimit': '-2.76', 'upperLimit': '8.07'}]}]}, {'title': 'Executive Functioning: ET (n=23, 26)', 'categories': [{'measurements': [{'value': '-6.7', 'spread': '9.1', 'groupId': 'OG000', 'lowerLimit': '-10.61', 'upperLimit': '-2.77'}, {'value': '4.6', 'spread': '13.2', 'groupId': 'OG001', 'lowerLimit': '-0.68', 'upperLimit': '9.95'}]}]}, {'title': 'Executive Functioning: Week 6 [LOCF] (n=146, 71)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '14.9', 'groupId': 'OG000', 'lowerLimit': '-1.04', 'upperLimit': '3.88'}, {'value': '3.2', 'spread': '16.6', 'groupId': 'OG001', 'lowerLimit': '-0.71', 'upperLimit': '7.14'}]}]}, {'title': 'Working Memory: Week 6 (n=120, 45)', 'categories': [{'measurements': [{'value': '1.9', 'spread': '12.9', 'groupId': 'OG000', 'lowerLimit': '-0.40', 'upperLimit': '4.26'}, {'value': '0.5', 'spread': '12.9', 'groupId': 'OG001', 'lowerLimit': '-3.32', 'upperLimit': '4.41'}]}]}, {'title': 'Working Memory: ET (n=23, 24)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '13.5', 'groupId': 'OG000', 'lowerLimit': '-2.66', 'upperLimit': '9.03'}, {'value': '3.7', 'spread': '11.0', 'groupId': 'OG001', 'lowerLimit': '-0.93', 'upperLimit': '8.39'}]}]}, {'title': 'Working Memory: Week 6 [LOCF] (n=143, 68)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '12.9', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '4.10'}, {'value': '1.3', 'spread': '12.2', 'groupId': 'OG001', 'lowerLimit': '-1.64', 'upperLimit': '4.27'}]}]}, {'title': 'Sustained Attention: Week 6 (n=120, 45)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '12.3', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '4.26'}, {'value': '-1.6', 'spread': '13.1', 'groupId': 'OG001', 'lowerLimit': '-5.59', 'upperLimit': '2.30'}]}]}, {'title': 'Sustained Attention: ET (n=23, 24)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '13.5', 'groupId': 'OG000', 'lowerLimit': '-5.27', 'upperLimit': '6.37'}, {'value': '1.5', 'spread': '11.6', 'groupId': 'OG001', 'lowerLimit': '-3.42', 'upperLimit': '6.37'}]}]}, {'title': 'Sustained Attention: Week 6 [LOCF] (n=143, 68)', 'categories': [{'measurements': [{'value': '1.7', 'spread': '12.4', 'groupId': 'OG000', 'lowerLimit': '-0.54', 'upperLimit': '3.47'}, {'value': '-0.9', 'spread': '12.6', 'groupId': 'OG001', 'lowerLimit': '-3.98', 'upperLimit': '2.10'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, ET', 'description': "A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 \\[not sleepy\\] to 10 \\[very sleepy\\]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \\>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Neurocognitive Index: Week 6 (n=120, 45)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'Neurocognitive Index: ET (n=23, 23)', 'categories': [{'measurements': [{'value': '-2.7', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'Neurocognitive Index: Week 6 [LOCF] (n=143, 67)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2613', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.34', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '3.69', 'pValueComment': 'SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.19', 'groupDescription': 'Neurocognitive Index score at Week 6: difference from placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Observed cases at Week 6.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, ET', 'description': "A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 \\[not sleepy\\] to 10 \\[very sleepy\\]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \\>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Week 1 (n=189, 85)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.8', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '0.93'}, {'value': '0.1', 'spread': '0.9', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '0.29'}]}]}, {'title': 'Week 2 (n=182, 85)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.17', 'upperLimit': '0.88'}, {'value': '-0.0', 'spread': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.13', 'upperLimit': '0.08'}]}]}, {'title': 'Week 3 (n=165, 74)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '3.1', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '1.15'}, {'value': '0.3', 'spread': '1.6', 'groupId': 'OG001', 'lowerLimit': '-0.09', 'upperLimit': '0.65'}]}]}, {'title': 'Week 4 (n=154, 62)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.6', 'groupId': 'OG000', 'lowerLimit': '-0.01', 'upperLimit': '0.83'}, {'value': '-0.0', 'spread': '0.6', 'groupId': 'OG001', 'lowerLimit': '-0.20', 'upperLimit': '0.11'}]}]}, {'title': 'Week 5 (n=141, 54)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.4', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '0.63'}, {'value': '-0.0', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '-0.30', 'upperLimit': '0.26'}]}]}, {'title': 'Week 6 (n=134, 52)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.5', 'groupId': 'OG000', 'lowerLimit': '-0.27', 'upperLimit': '0.58'}, {'value': '-0.2', 'spread': '0.8', 'groupId': 'OG001', 'lowerLimit': '-0.37', 'upperLimit': '0.06'}]}]}, {'title': 'Week 6 [LOCF] (n=189, 86)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.5', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '0.63'}, {'value': '-0.1', 'spread': '0.6', 'groupId': 'OG001', 'lowerLimit': '-0.21', 'upperLimit': '0.07'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': 'SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Week 1 (n=190, 86)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.15'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.20'}]}]}, {'title': 'Week 2 (n=183, 86)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.02', 'upperLimit': '0.22'}, {'value': '0.0', 'spread': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.07'}]}]}, {'title': 'Week 3 (n=166, 74)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.15'}, {'value': '0.0', 'spread': '0.3', 'groupId': 'OG001', 'lowerLimit': '-0.02', 'upperLimit': '0.10'}]}]}, {'title': 'Week 4 (n=155, 63)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.15'}, {'value': '-0.0', 'spread': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.01'}]}]}, {'title': 'Week 5 (n=142, 54)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.03', 'upperLimit': '0.15'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.05', 'upperLimit': '0.05'}]}]}, {'title': 'Week 6 (n=135, 52)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000', 'lowerLimit': '-0.06', 'upperLimit': '0.11'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.06', 'upperLimit': '0.06'}]}]}, {'title': 'Week 6 [LOCF] (n=190, 87)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.08', 'upperLimit': '0.08'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.04', 'upperLimit': '0.06'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': 'BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Week 1 (n=190, 86)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.6', 'groupId': 'OG000', 'lowerLimit': '-0.04', 'upperLimit': '0.42'}, {'value': '-0.0', 'spread': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '0.06'}]}]}, {'title': 'Week 2 (n=183, 86)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.6', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '0.37'}, {'value': '0.0', 'spread': '0.6', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '0.17'}]}]}, {'title': 'Week 3 (n=166, 74)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.3', 'groupId': 'OG000', 'lowerLimit': '-0.12', 'upperLimit': '0.28'}, {'value': '0.1', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '-0.08', 'upperLimit': '0.37'}]}]}, {'title': 'Week 4 (n=155, 63)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.8', 'groupId': 'OG000', 'lowerLimit': '-0.07', 'upperLimit': '0.18'}, {'value': '-0.0', 'spread': '0.8', 'groupId': 'OG001', 'lowerLimit': '-0.23', 'upperLimit': '0.17'}]}]}, {'title': 'Week 5 (n=142, 54)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.7', 'groupId': 'OG000', 'lowerLimit': '-0.18', 'upperLimit': '0.05'}, {'value': '0.0', 'spread': '0.4', 'groupId': 'OG001', 'lowerLimit': '-0.12', 'upperLimit': '0.12'}]}]}, {'title': 'Week 6 (n=135, 52)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.11'}, {'value': '0.0', 'spread': '0.5', 'groupId': 'OG001', 'lowerLimit': '-0.15', 'upperLimit': '0.15'}]}]}, {'title': 'Week 6 [LOCF] (n=190, 87)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.8', 'groupId': 'OG000', 'lowerLimit': '-0.11', 'upperLimit': '0.11'}, {'value': '-0.0', 'spread': '0.7', 'groupId': 'OG001', 'lowerLimit': '-0.18', 'upperLimit': '0.14'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': "AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Per Response on the School Placement Questionnaire: School Situation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Baseline: Enrolled or attend (n=185, 85)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Not attend or mental illness (n=185, 85)', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Not attend or other (n=185, 85)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Enrolled or vacation (n=185, 85)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Not enrolled or mental illness', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Not enrolled or other (n=185, 85)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Enrolled or attend (n=179, 84)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Not attend or mental illness (n=179, 84)', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Not attend or other (n=179, 84)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Enrolled or vacation (n=179, 84)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Not enrolled or mental illness (n=179, 84)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Not enrolled or other (n=179, 84)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Enrolled or attend (n=134, 51)', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Not attend or mental illness (n=134, 51)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Not attend or other (n=134, 51)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Enrolled or vacation (n=134, 51)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Not enrolled or mental illness (n=134, 51)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Not enrolled or other (n=134, 51)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'ET: Enrolled or attend (n=32, 25)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ET: Not attend or mental illness (n=32, 25)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'ET: Not attend or other (n=32, 25)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ET: Enrolled or vacation (n=32, 25)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'ET: Not enrolled or mental illness (n=32, 25)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ET: Not enrolled or other (n=32, 25)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Enrolled or attend (n=183, 86)', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Not attend or mental illness', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Not attend or other (n=183, 86)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Enrolled or vacation (n=183, 86)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Not enrolled or mental illness', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Not enrolled or other (n=183, 86)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 6, ET', 'description': 'School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Per Response on the School Placement Questionnaire: School Attendance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Baseline: No absences (n=88, 42)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Only a few absences (n=88, 42)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Frequent absences (n=88, 42)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Did not attend (n=88, 42)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Not applicable or vacation (n=88, 42)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: No absences (n=82, 36)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Only a few absences (n=82, 36)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Frequent absences (n=82, 36)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Did not attend (n=82, 36)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Not applicable or vacation (n=82, 36)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: No absences (n=67, 24)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Only a few absences (n=67, 24)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Frequent absences (n=67, 24)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Did not attend (n=67, 24)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Not applicable or vacation (n=67, 24)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'ET: No absences (n=12, 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ET: Only a few absences (n=12, 12)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ET: Frequent absences (n=12, 12)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'ET: Did not attend (n=12, 12)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'ET: Not applicable or vacation (n=12, 12)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: No absences (n=89, 37)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Only a few absences (n=89, 37)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Frequent absences (n=89, 37)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Did not attend (n=89, 37)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 6[LOCF]: Not applicable or vacation(n=89,37)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 6, ET', 'description': 'School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'classes': [{'title': 'Baseline: Excellent (n=64, 29)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Good (n=64, 29)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Fair (n=64, 29)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Poor (n=64, 29)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Very poor (n=64, 29)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Excellent (n=60, 26)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Good (n=60, 26)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Fair (n=60, 26)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Poor (n=60, 26)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 2: Very poor (n=60, 26)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Excellent (n=52, 21)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Good (n=52, 21)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Fair (n=52, 21)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Poor (n=52, 21)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6: Very poor (n=52, 21)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ET: Excellent (n=8, 7)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ET: Good (n=8, 7)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ET: Fair (n=8, 7)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'ET: Poor (n=8, 7)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ET: Very poor (n=8, 7)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Excellent (n=68, 28)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Good (n=68, 28)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Fair (n=68, 28)', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Poor (n=68, 28)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 6 [LOCF]: Very poor (n=68, 28)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, Week 6, ET', 'description': 'School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'comment': 'Includes 1 subject randomized but not treated', 'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'Received Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Laboratory abnormality', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A planned interim analysis resulted in recommendation from Data Safety Monitoring Board (DSMB) to terminate study due to futility per the interim analysis charter (p-value = 0.9840). Only one active subject in the study was affected by this decision.', 'preAssignmentDetails': 'Screening visit followed by a 1 to 10 day period to allow for wash-out of exclusionary medications.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ziprasidone', 'description': 'Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight \\< 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight \\< 45 kg) for duration of the study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>12 years and <13 years at start of treatment', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Between 13 and 17 years', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '15.3', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity', 'classes': [{'title': 'Hispanic / Latino', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic / Latino', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '176', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'particpants'}, {'title': 'Tanner adolescent pubertal self-assessment: Breast (females)', 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Stage 4', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Stage 5', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Not applicable', 'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not answered)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).', 'unitOfMeasure': 'particpants'}, {'title': 'Tanner adolescent pubertal self-assessment: Genitalia (males)', 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Stage 4', 'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}]}, {'title': 'Stage 5', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Not applicable', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not answered)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).', 'unitOfMeasure': 'participants'}, {'title': 'Tanner adolescent pubertal self-assessment: Pubic hair (females and males)', 'classes': [{'title': 'Stage 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Stage 3', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Stage 4', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}, {'title': 'Stage 5', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'Missing (not answered)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '164.9', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '167.8', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '165.8', 'spread': '10.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '64.3', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '62.2', 'spread': '15.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, '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': 284}}, 'statusModule': {'whyStopped': 'Please see Detailed Description for termination reason.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2005-11-21', 'resultsFirstSubmitDate': '2010-03-23', 'studyFirstSubmitQcDate': '2005-11-21', 'lastUpdatePostDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-03-23', 'studyFirstPostDateStruct': {'date': '2005-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': "CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected."}, {'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.'}, {'measure': 'Change From Baseline in PANSS: Positive and Negative Subscales at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': 'PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.'}, {'measure': 'Clinical Global Impression of Improvement (CGI-I) Score at Week 6', 'timeFrame': 'Baseline, Week 6', 'description': "CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected."}, {'measure': "Change From Baseline in Children's Global Assessment Scale (CGAS)", 'timeFrame': 'Baseline, Week 2, Week 4, Week 6, Early termination (ET)', 'description': 'CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the "normal" range; lower score indicates need for increased supervision.'}, {'measure': 'Change From Baseline in Child Health Questionnaire (CHQ)', 'timeFrame': 'Baseline, Week 6, ET', 'description': "CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child's physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status."}, {'measure': "Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score", 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': "CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression."}, {'measure': 'Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': "CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment."}, {'measure': 'Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': "CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment)."}, {'measure': 'Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1', 'timeFrame': 'Baseline, Week 2, Week 6', 'description': "Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment)."}, {'measure': 'Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales', 'timeFrame': 'Baseline, Week 6, ET', 'description': "A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 \\[not sleepy\\] to 10 \\[very sleepy\\]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \\>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79)."}, {'measure': 'Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index', 'timeFrame': 'Baseline, Week 6, ET', 'description': "A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 \\[not sleepy\\] to 10 \\[very sleepy\\]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores were rated as above average (score \\>109), average (90 to 109), below average (80 to 89), or well below average (70 to 79)."}, {'measure': 'Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': 'SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.'}, {'measure': 'Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': 'BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.'}, {'measure': 'Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score', 'timeFrame': 'Baseline, Week 1 through Week 6', 'description': "AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity."}, {'measure': 'Number of Subjects Per Response on the School Placement Questionnaire: School Situation', 'timeFrame': 'Baseline, Week 2, Week 6, ET', 'description': 'School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.'}, {'measure': 'Number of Subjects Per Response on the School Placement Questionnaire: School Attendance', 'timeFrame': 'Baseline, Week 2, Week 6, ET', 'description': 'School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.'}, {'measure': 'Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance', 'timeFrame': 'Baseline, Week 2, Week 6, ET', 'description': 'School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Adolescent Subjects With Schizophrenia'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '24111983', 'type': 'DERIVED', 'citation': 'Findling RL, Cavus I, Pappadopulos E, Vanderburg DG, Schwartz JH, Gundapaneni BK, DelBello MP. Ziprasidone in adolescents with schizophrenia: results from a placebo-controlled efficacy and long-term open-extension study. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):531-44. doi: 10.1089/cap.2012.0068. Epub 2013 Oct 10.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281134&StudyName=Safety%20and%20efficacy%20of%20ziprasidone%20in%20adolescents%20with%20schizophrenia', '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 adolescents (ages 13-17) with schizophrenia', 'detailedDescription': 'Termination Reason: On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia: Current symptoms were to be present for at least 7 days before screening.\n* At the Screening and Baseline visits, subjects must have had a Brief Psychiatric Rating Scale - Anchored score ≥35 and a score of ≥4 on at least 1 of the following items: unusual thought content (i.e., delusions), hallucinations, suspiciousness, or conceptual disorganization.\n* Age 13 - 17 years\n\nExclusion Criteria:\n\n* Imminent risk of suicide or homicide, as judged by the site investigator\n* Any history of serious or unstable medical illness, including risk for QT prolongation'}, 'identificationModule': {'nctId': 'NCT00257192', 'briefTitle': 'Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Six Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia', 'orgStudyIdInfo': {'id': 'A1281134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '2.0', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1.0', 'interventionNames': ['Drug: Ziprasidone oral capsules']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'Placebo matching the oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing \\<45 kg, the doses will range from 20 mg BID to 40 mg BID.', 'armGroupLabels': ['2.0']}, {'name': 'Ziprasidone oral capsules', 'type': 'DRUG', 'otherNames': ['Geodon, Zeldox'], 'description': 'Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength or matching placebo. Subjects will be dosed daily for 6 weeks using a flexible dose design with a minimal dose range of 40mg BID to a maximum dose range of 80 mg BID. For subjects weighing \\<45 kg, the doses will range from 20 mg BID to 40 mg BID.', 'armGroupLabels': ['1.0']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294-4400', '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': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer 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'Pfizer Investigational Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60016', 'city': 'Des Plaines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.03336, 'lon': -87.8834}}, {'zip': '60181', 'city': 'Oakbrook Terrace', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.96451}}, {'zip': '60194', 'city': 'Schaumburg', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.03336, 'lon': -88.08341}}, {'zip': '21208', 'city': 'Pikesville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.37427, 'lon': -76.72247}}, {'zip': '21204', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '21286', 'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'zip': '48038', 'city': 'Clinton Township', 'state': 'Michigan', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.58698, 'lon': -82.91992}}, {'zip': '39301', 'city': 'Meridian', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.36431, 'lon': -88.70366}}, {'zip': '63044-2588', 'city': 'Bridgeton', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.767, 'lon': -90.41151}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '14209', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '14618', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45224', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73101', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73107', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73116', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational 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