Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT01001702
Status:
COMPLETED
Last Update Posted:
2013-09-27
First Post:
2009-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Oral Aripiprazole Open-Label Rollover Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068180', 'term': 'Aripiprazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800 562-3974', 'title': 'Global Medical Affair', 'organization': 'Otsuka Pharmaceutical Development and Commercialization'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.', 'otherNumAtRisk': 85, 'otherNumAffected': 45, 'seriousNumAtRisk': 85, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'seriousEvents': [{'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Impulsive behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Social stay hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Discontinuation due to AEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 72 months', 'description': 'An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.\n\nAn AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.\n\nAdditional information about Adverse Events can be found in the Adverse Event section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.26', 'spread': '1.07', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Last Visit (Up to 72 Months)', 'description': 'The rater or investigator answered the following question:\n\n"Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with baseline assessment and at least one post-baseline measurement for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Significant Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'classes': [{'title': 'Bilirubin, total (mg/dL)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Creatine phosphokinase (CPK), total (IU/L)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Eosinophils (%)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Hematocrit (%)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Hemoglobin (g/dL)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Prolactin (ng/mL)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Up to 72 Months', 'description': 'Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.\n\nClinically significant values are defined as the following:\n\nBilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase \\> 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years \\[Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)\\].\n\nEosinophils ≥ 10 %. Hematocrit \\< 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.\n\nHemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin \\> 1 times the upper limit of normal \\[Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with at least one post-baseline numeric result for the given laboratory test are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'classes': [{'title': 'Supine Heart Rate Increase', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Supine Heart Rate Decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Standing Heart Rate Increase', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Standing Heart Rate Decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Up to 72 months', 'description': 'Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'classes': [{'title': 'Supine Systolic Blood Pressure Increase', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Supine Systolic Blood Pressure Decrease', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Standing Systolic Blood Pressure Increase', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Standing Systolic Blood Pressure Decrease', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Supine Diastolic Blood Pressure Increase', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Supine Diastolic Blood Pressure Decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Standing Diastolic Blood Pressure Increase', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Standing Diastolic Blood Pressure Decrease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Up to 72 months', 'description': 'Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.\n\nSystolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.\n\nA diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'classes': [{'title': 'Sinus bradycardia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Supraventricular premature beat', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Ventricular premature beat', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Right bundle branch block', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other intraventricular block', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Symmetrical T-wave inversion', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'QTcB', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'QTcF', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'QTcN', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'QTcE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Up to 72 months', 'description': "A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.\n\nClinically significant ECGs were defined as:\n\nSinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.\n\nSupraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.\n\nSymmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett's formula), QTcF (QT interval corrected Fridericia's formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with at least one post-baseline numeric result for the given parameter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Showing Significant Weight Gain or Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'classes': [{'title': 'Weight Gain', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'Weight Loss', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Up to 72 months', 'description': 'Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with baseline assessment and at least one post-baseline numeric result for the given parameter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Up to 72 months', 'description': 'The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with available assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Sponsor Discontinued Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Subject met Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Investigator withdrew Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Lack of Efficacy per Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'An open-label rollover study for participants who completed study 31-03-241 (NCT00102518). The withdrawal criteria for this open label rollover study was completion by 31 December 2012 (or if Month 72 occurred within 6 months of this date) or if there was commercial availability.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.29', 'spread': '1.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-29', 'studyFirstSubmitDate': '2009-10-22', 'resultsFirstSubmitDate': '2013-07-29', 'studyFirstSubmitQcDate': '2009-10-23', 'lastUpdatePostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-29', 'studyFirstPostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths', 'timeFrame': 'Up to 72 months', 'description': 'An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a subject. Change in clinical relevance (severity increased) was entered as a new AE in the current trial. Abnormal laboratory test findings were considered AEs if, in the opinion of the investigator, they represented an abnormal (clinically significant) change from baseline for that individual subject.\n\nAn AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention.\n\nAdditional information about Adverse Events can be found in the Adverse Event section.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impression Severity of Illness (CGI-S) Score', 'timeFrame': 'Baseline, Last Visit (Up to 72 Months)', 'description': 'The rater or investigator answered the following question:\n\n"Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" Response choices included: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. A negative change from Baseline indicated improvement'}, {'measure': 'Number of Participants With Clinical Significant Laboratory Tests', 'timeFrame': 'Baseline, Up to 72 Months', 'description': 'Blood was collected for Fasting clinical laboratory tests (serum chemistry and hematology) at Baseline, Months 12, 24, 36, 48, 60, and 72 and were analyzed at a central laboratory.\n\nClinically significant values are defined as the following:\n\nBilirubin, total ≥ 2.0 mg/dL. Creatine phosphokinase \\> 500 U/L for participants 13-17 years or 3 times the upper limit of normal for participants ≥ 18 years \\[Reference Range (0 to 190 IU/L (females) and 0 to 235 IU/L (males)\\].\n\nEosinophils ≥ 10 %. Hematocrit \\< 30 % for participants 13-17 years old or ≥ 18 year old participants female ≤ 32 % and a 3 point decrease from baseline or male ≤ 37 % and a 3 point decrease from baseline.\n\nHemoglobin female ≤ 9.5 g/dL or male ≤ 11.5 g/dL. Prolactin \\> 1 times the upper limit of normal \\[Reference range: 2 to 18 ng/mL (males) and 3 to 30 ng/mL (females)\\].'}, {'measure': 'Number of Participants With Clinically Significant Heart Rate', 'timeFrame': 'Baseline, Up to 72 months', 'description': 'Heart rate was measured at Baseline and at each visit supine (lying on the back) and standing. A heart rate increase is an increase of ≥ 15 beats per minute (bpm) compared to Baseline. A heart rate decrease is a decrease of ≥ 15 bpm compared to Baseline.'}, {'measure': 'Number of Participants With Clinically Significant Blood Pressure', 'timeFrame': 'Baseline, Up to 72 months', 'description': 'Systolic and Diastolic blood pressure was measured at Baseline and at all visits supine (lying on the back) and standing.\n\nSystolic increase was an increase of ≥ 20 mm Hg compared to Baseline and systolic decrease was a decrease of ≥ 20 mm Hg compared to Baseline.\n\nA diastolic increase was an increase of ≥ 15 mm Hg compared to Baseline and a diastolic decrease was a decrease of ≥ 15 mm Hg compared to Baseline.'}, {'measure': 'Number of Participants With Clinically Abnormal Changes in Electrocardiograms (ECGs) Evaluations', 'timeFrame': 'Baseline, Up to 72 months', 'description': "A 12-lead ECG was recorded at Baseline, Months 6, 12, 24, 36, 48, 60 and 72. Three readings taken 5 minutes were read by a central ECG reading service and averaged.\n\nClinically significant ECGs were defined as:\n\nSinus Bradycardia: ≤ 50 beats per minute (bpm), decrease of ≥ 15 bpm from Baseline.\n\nSupraventricular premature beat: ≥ 2 per 10 seconds, increase from Baseline. Ventricular premature beat: ≥ 1 per 10 seconds, increase from Baseline. Right bundle branch block: present. Other intraventricular block: QRS ≥ 0.10 seconds for age 13-17 years or QRS ≥ 0.11 seconds for age ≥ 18 years, an increase of ≥ 0.02 seconds from Baseline.\n\nSymmetrical T-wave inversion: present. QTcB (QT interval corrected Bazett's formula), QTcF (QT interval corrected Fridericia's formula), QTcN (QT corrected FDA Neuropharmacology Division formula), QTcE (QT corrected fractional exponent correction method: ≥ 420 msec for age 13-17 years or ≥ 450 msec for age ≥ 18 years, ≥ 10 % increase from Baseline."}, {'measure': 'Number of Participants Showing Significant Weight Gain or Loss', 'timeFrame': 'Baseline, Up to 72 months', 'description': 'Weight was measured at Baseline, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72. A clinically significant weight gain was defined as a ≥ 7 % increase from Baseline. A clinically significant Weight loss was defined as a ≥ 7% decrease from Baseline.'}, {'measure': 'Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, Up to 72 months', 'description': 'The C-SSRS consisted of a baseline evaluation (completed at the first scheduled visit upon approval of protocol Amendment 3) that assessed the lifetime experience of the participant with suicide events and suicidal ideation and a post-baseline evaluation at each visit that focused on suicidality since the last trial visit. Some questions are yes/no and some are on a scale of 1 (low severity) to 5 (high severity). The number of participants experiencing suicidal ideation or suicidal behavior is reported.'}]}, 'conditionsModule': {'keywords': ['Open Label', 'Aripiprazole'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the long-term safety and tolerability of oral aripiprazole in adolescent patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a confirmed Axis I Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia who must have completed Otsuka study 31-03-241 (NCT00102518) treatment of adolescent subjects with schizophrenia\n\nExclusion Criteria:\n\n* Patients with a co-morbid serious, uncontrolled systemic illness\n* Patients with a significant risk of committing suicide'}, 'identificationModule': {'nctId': 'NCT01001702', 'briefTitle': 'Oral Aripiprazole Open-Label Rollover Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'An Open- Label Rollover Study for Subjects With Schizophrenia Completing ABILIFY® (Aripiprazole) Clinical Study 31-03-241', 'orgStudyIdInfo': {'id': '31-05-243'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Aripiprazole', 'description': 'Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.', 'interventionNames': ['Drug: Aripiprazole']}], 'interventions': [{'name': 'Aripiprazole', 'type': 'DRUG', 'otherNames': ['ABILIFY®'], 'description': 'Flexible dose between 5 mg and 30 mg Aripiprazole tablets.', 'armGroupLabels': ['Oral Aripiprazole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Study site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Study site', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'city': 'Split', 'country': 'Croatia', 'facility': 'Study site', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'city': 'Hyderabad', 'country': 'India', 'facility': 'Study site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Ludhiana', 'country': 'India', 'facility': 'Study site', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'city': 'Mumbai', 'country': 'India', 'facility': 'Study site', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Tamilnadu', 'country': 'India', 'facility': 'Study site'}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Study site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Study site', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Study site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Study site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'city': 'Belgrade', 'country': 'Serbia', 'facility': 'Study site', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Novi Sad', 'country': 'Serbia', 'facility': 'Study site', 'geoPoint': {'lat': 45.25167, 'lon': 19.83694}}, {'city': 'Kharkiv', 'country': 'Ukraine', 'facility': 'Study site', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kiev', 'country': 'Ukraine', 'facility': 'Study site', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}