Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT00757705
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2008-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants 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': '886 2 23762155', 'title': 'Medical Director', 'organization': 'Janssen Research & Development'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.'}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to Week 24', 'eventGroups': [{'id': 'EG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug.", 'otherNumAtRisk': 299, 'otherNumAffected': 180, 'seriousNumAtRisk': 299, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Muscle Rigidity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Akathisia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Bradykinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Extrapyramidal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 35}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 27}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Hallucination, Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 62}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Panic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Sleep Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Blood Electrolytes Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Hepatic Neoplasm Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Haemorrhage Intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Hallucination, Auditory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 299, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'title': 'Baseline (n=297)', 'categories': [{'measurements': [{'value': '72.4', 'spread': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24 (n=281)', 'categories': [{'measurements': [{'value': '-6.9', 'spread': '17.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using last observation carried forward (LOCF). Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'title': 'Positive symptoms: Baseline (n=297)', 'categories': [{'measurements': [{'value': '21.6', 'spread': '7.2', 'groupId': 'OG000'}]}]}, {'title': 'Positive symptoms:Change at Week 24 (n=281)', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Negative symptoms: Baseline (n=297)', 'categories': [{'measurements': [{'value': '17.0', 'spread': '7.0', 'groupId': 'OG000'}]}]}, {'title': 'Negative symptoms:Change at Week 24 (n=281)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Disorganized thoughts: Baseline (n=297)', 'categories': [{'measurements': [{'value': '16.7', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'Disorganized thoughts: Change at Week 24 (n=281)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'UH/E: Baseline (n=297)', 'categories': [{'measurements': [{'value': '7.5', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'UH/E: Change at Week 24 (n=281)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '3.9', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/depression: Baseline (n=297)', 'categories': [{'measurements': [{'value': '9.7', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Anxiety/depression:Change at Week 24(n=281)', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'categories': [{'measurements': [{'value': '31.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'title': 'Baseline (n=297)', 'categories': [{'measurements': [{'value': '54.5', 'spread': '13.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24 (n=269)', 'categories': [{'measurements': [{'value': '3.4', 'spread': '12.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '273', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'title': 'Baseline (n=273)', 'categories': [{'measurements': [{'value': '48.9', 'spread': '14.7', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24 (n=246)', 'categories': [{'measurements': [{'value': '5.8', 'spread': '15.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'title': 'Baseline (n=297)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 24 (n=279)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', '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 participant. 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 participants".', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'title': 'PCS: Baseline (n=293)', 'categories': [{'measurements': [{'value': '61.3', 'spread': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'PCS: Change at Week 24 (n=225)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '16.1', 'groupId': 'OG000'}]}]}, {'title': 'MCS: Baseline (n=295)', 'categories': [{'measurements': [{'value': '53.1', 'spread': '21.5', 'groupId': 'OG000'}]}]}, {'title': 'MCS: Change at Week 24 (n=228)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '18.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population: all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Missing data was imputed using LOCF. Here 'N' (Number of Participants Analyzed) signifies number of participants who were evaluable for this measure. 'n' signifies those participants who were evaluable at specified time point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Satisfaction With the Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Very poor', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'classes': [{'title': 'Quality of sleep: Baseline (n=297)', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Quality of sleep:Change at Week 24 (n=278)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Daytime drowsiness: Baseline (n=297)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Daytime drowsiness:Change at Week 24 (n=278)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '299'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Insufficient Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'Ineligible to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '299', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received flexible dose of 3 to 12 milligram (mg) of paliperidone ER once daily orally for 24 weeks. Dose adjustment was done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.1', 'spread': '11.85', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '162', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 299}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-05', 'studyFirstSubmitDate': '2008-09-19', 'resultsFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2008-09-19', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-05', 'studyFirstPostDateStruct': {'date': '2008-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement (UH/E) subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.'}, {'measure': 'Percentage of Participants With at Least 20 Percent Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score', 'timeFrame': 'Up to Week 24', 'description': 'The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.'}, {'measure': 'Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty).'}, {'measure': 'Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.'}, {'measure': 'Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 24', 'timeFrame': 'Baseline, Week 24', '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 participant. 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 participants".'}, {'measure': 'Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.'}, {'measure': 'Number of Participants With Satisfaction With the Study Treatment', 'timeFrame': 'Week 24', 'description': 'Participants assessed their satisfaction with paliperidone ER on a 5-point scale (very good, good, moderate, poor or very poor).'}, {'measure': 'Change From Baseline in Sleep Quality and Daytime Drowsiness Score at Week 24', 'timeFrame': 'Baseline, Week 24', 'description': 'The Sleep Quality and Daytime Drowsiness evaluation scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicated on a 5 point scale how well they have slept in the previous 7 days, score ranging from 1 (very badly) to 5 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 1 (not at all) to 5 (all the time).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Paliperidone Extended-Release'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to explore the maintained efficacy, tolerability, and safety of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with other oral atypical antipsychotic medication.', 'detailedDescription': "This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance), single arm, multicenter (when more than one hospital or medical school team work on a medical research study), 24-week study. Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication without the need for titration due to lack of efficacy, lack of tolerability or safety, lack of compliance or other reason. A transition period of maximum 4 weeks will be allowed. Throughout the study, participants will receive flexible dose of 3 to 12 milligram (mg) of paliperidone once daily orally for 24 weeks. Dose adjustment will be done as per Investigator's discretion based upon participant's clinical response to and tolerability of the study drug. Assessments of efficacy will be performed at screening and after 2, 4, 12 and 24 weeks. Efficacy will primarily be evaluated by means of Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia\n* Participant has been given an adequate dose of an appropriate oral atypical 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* Participant or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study\n* Female participants 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 and must also have a negative urine pregnancy test at screening\n* Male or female, aged greater than or equal to 18 years\n\nExclusion Criteria:\n\n* Participants on clozapine, any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months\n* Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities\n* Participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)\n* Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)\n* Participants with a current use or known history (over the past 6 months) of substance dependence except for nicotine, caffeine, and betal nut according to DSM-IV Criteria'}, 'identificationModule': {'nctId': 'NCT00757705', 'briefTitle': 'An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended-Release (ER) in Participants With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Taiwan Ltd'}, 'officialTitle': 'An Open-label Prospective Trial to Evaluate the Tolerability, Safety and Maintained Efficacy of a Transition to Paliperidone ER in Subjects With Schizophrenia Previously Unsuccessfully Treated With Other Oral Antipsychotics', 'orgStudyIdInfo': {'id': 'CR014308'}, 'secondaryIdInfos': [{'id': 'R076477SCH4033'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paliperidone Extended-Release (ER)', 'interventionNames': ['Drug: Paliperidone ER']}], 'interventions': [{'name': 'Paliperidone ER', 'type': 'DRUG', 'otherNames': ['R076477', 'Invega'], 'description': "Participants will receive paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day orally once daily for 24 weeks as per Investigator's discretion based on the individual participant's clinical response to and tolerability of the study drug.", 'armGroupLabels': ['Paliperidone Extended-Release (ER)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Johnson & Johnson Taiwan, Ltd. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Taiwan Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Taiwan Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}