Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-27 @ 6:57 AM
Study NCT ID:
NCT01724359
Status:
COMPLETED
Last Update Posted:
2013-03-15
First Post:
2012-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia
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': 'D000068882', 'term': 'Paliperidone Palmitate'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '52 55 5237 3410', 'title': 'GERENTE MEDICO REGIONAL', 'organization': 'Jan-Cil Mexico'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.', 'otherNumAtRisk': 95, 'otherNumAffected': 39, 'seriousNumAtRisk': 95, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 22}], 'organSystem': 'Nervous system disorders'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 24}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 15}], 'organSystem': 'Nervous system disorders'}], 'seriousEvents': [{'term': 'Psychotic episode', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Clinical deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Major depressive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Worsening of the psychiatric condition with aggressive behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 95, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Baseline (n= 70)', 'categories': [{'measurements': [{'value': '83.99', 'spread': '22.16', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n= 70)', 'categories': [{'measurements': [{'value': '53.70', 'spread': '18.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Baseline (n= 70)', 'categories': [{'measurements': [{'value': '18.53', 'spread': '7.30', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n= 70)', 'categories': [{'measurements': [{'value': '11.16', 'spread': '4.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Baseline (n= 70)', 'categories': [{'measurements': [{'value': '23.69', 'spread': '6.42', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n= 70)', 'categories': [{'measurements': [{'value': '14.64', 'spread': '5.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Baseline (n= 70)', 'categories': [{'measurements': [{'value': '41.77', 'spread': '11.39', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n= 70)', 'categories': [{'measurements': [{'value': '27.90', 'spread': '10.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Severity (CGIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients at Baseline: Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}, {'id': 'OG001', 'title': 'Patients at Week 26: Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Normal, not at all ill', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Borderline mentally ill', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Mildly ill', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Moderately ill', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Markedly ill', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severely ill', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Among the most extremely ill', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 26', 'description': 'The CGI-S rating scale is a 7 point global assessment that measures the clinician\'s impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}, {'type': 'SECONDARY', 'title': 'Personal and Social Performance (PSP) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Baseline (n= 95)', 'categories': [{'measurements': [{'value': '52.06', 'spread': '15.27', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n= 78)', 'categories': [{'measurements': [{'value': '68.24', 'spread': '15.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': "This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =\\< 30, functioning so poorly as to require intensive supervision.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}, {'type': 'SECONDARY', 'title': 'Health Status as Measured by Self-rated Health Status Survey SF-36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Baseline (n= 95)', 'categories': [{'measurements': [{'value': '56.39', 'spread': '18.14', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n= 86)', 'categories': [{'measurements': [{'value': '67.02', 'spread': '21.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': "The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}, {'type': 'SECONDARY', 'title': 'Sleep Evaluation Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Baseline (n= 71)', 'categories': [{'measurements': [{'value': '6.80', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n= 71)', 'categories': [{'measurements': [{'value': '7.66', 'spread': '2.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}, {'type': 'SECONDARY', 'title': 'Daytime Drowsiness Evaluation Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'classes': [{'title': 'Baseline (n= 71)', 'categories': [{'measurements': [{'value': '4.68', 'spread': '3.21', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n= 71)', 'categories': [{'measurements': [{'value': '2.58', 'spread': '2.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26', 'description': 'This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}]}], 'preAssignmentDetails': 'Patients who received paliperidone extended-release (ER) at least once and provide at least 1 post baseline efficacy measurement will be included in the intent-to-treat (ITT) analysis set for efficacy. Patients who received paliperidone ER at least once and provide any post-baseline information will be included in the ITT analysis set for safety.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Paliperidone Extended-release (ER)', 'description': 'The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.86', 'spread': '12.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}, {'title': 'Colombia', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-04', 'studyFirstSubmitDate': '2012-11-07', 'resultsFirstSubmitDate': '2012-11-27', 'studyFirstSubmitQcDate': '2012-11-07', 'lastUpdatePostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-04', 'studyFirstPostDateStruct': {'date': '2012-11-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score', 'timeFrame': 'Baseline, Week 26', 'description': 'The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score', 'timeFrame': 'Baseline, Week 26', 'description': 'The PANSS Positive Subscale assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).'}, {'measure': 'Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score', 'timeFrame': 'Baseline, Week 26', 'description': 'The PANSS Negative Subscale assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).'}, {'measure': 'Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score', 'timeFrame': 'Baseline, Week 26', 'description': 'The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology).'}, {'measure': 'Clinical Global Impression-Severity (CGIS)', 'timeFrame': 'Baseline, Week 26', 'description': 'The CGI-S rating scale is a 7 point global assessment that measures the clinician\'s impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening.'}, {'measure': 'Personal and Social Performance (PSP) Scale', 'timeFrame': 'Baseline, Week 26', 'description': "This PSP assesses the degree of a patient's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =\\< 30, functioning so poorly as to require intensive supervision."}, {'measure': 'Health Status as Measured by Self-rated Health Status Survey SF-36', 'timeFrame': 'Baseline, Week 26', 'description': "The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts."}, {'measure': 'Sleep Evaluation Scale', 'timeFrame': 'Baseline, Week 26', 'description': 'This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well).'}, {'measure': 'Daytime Drowsiness Evaluation Scale', 'timeFrame': 'Baseline, Week 26', 'description': 'This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Paliperidone extended-release (ER)', 'Antipsychotic agents'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.', 'detailedDescription': "This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient meets the criteria for schizophrenia\n* Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication\n* Patient is healthy on the basis of a physical examination and vital signs at screening\n* Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study\n\nExclusion Criteria:\n\n* Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months\n* Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities\n* Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome\n* Patients judged to be at high risk for adverse events, violence, or self-harm\n* Patients with known hypersensitivity to paliperidone ER or to risperidone\n* Patients with a current use or known history (over the past 6 months) of substance dependence'}, 'identificationModule': {'nctId': 'NCT01724359', 'acronym': 'PERFLEX', 'briefTitle': 'Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag, S.A.'}, 'officialTitle': 'An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia', 'orgStudyIdInfo': {'id': 'CR017413'}, 'secondaryIdInfos': [{'id': 'R076477SCH3029', 'type': 'OTHER', 'domain': 'Janssen-Cilag Colombia'}, {'id': 'R076477SCH3036', 'type': 'OTHER', 'domain': 'Janssen-Cilag Argentina'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paliperidone ER', 'interventionNames': ['Drug: Paliperidone ER']}], 'interventions': [{'name': 'Paliperidone ER', 'type': 'DRUG', 'description': "The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.", 'armGroupLabels': ['Paliperidone ER']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Rosario', 'country': 'Argentina', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Bogotá', 'country': 'Colombia', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'city': 'Cali', 'country': 'Colombia', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'city': 'MedellĂn', 'country': 'Colombia', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}], 'overallOfficials': [{'name': 'Janssen-Cilag S.A. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag, S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}