Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT01577160
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2012-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response 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': {'eventGroups': [{'id': 'EG000', 'title': 'Paliperidone ER', 'description': "Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score.", 'otherNumAtRisk': 353, 'otherNumAffected': 140, 'seriousNumAtRisk': 353, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Extrapyramidal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 25}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 8}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 9}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 56}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 353, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score."}], 'classes': [{'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '16.68', 'upperLimit': '27.13'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'The CGI-I is a 7-point scale that requires the clinician to assess how much the participant\'s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', '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. Here 'N' (Number of Participants Analyzed) signifies those participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score."}], 'classes': [{'title': 'Baseline (n=331)', 'categories': [{'measurements': [{'value': '5.0', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12 (n=255)', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', '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". Higher scores indicate worsening.', '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."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '255', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score."}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '3', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': "The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.", '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 those participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Personal and Social Performance (PSP) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score."}], 'classes': [{'title': 'Baseline (n=331)', 'categories': [{'measurements': [{'value': '42.6', 'spread': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12 (n=267)', 'categories': [{'measurements': [{'value': '14.3', 'spread': '13.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', '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. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Drug Attitude Inventory (DAI-10) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Paliperidone Extended Release (ER)', 'description': "Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score."}], 'classes': [{'title': 'Baseline (n=331)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 12 (n=267)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).", '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 ER', 'description': "Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's Clinical Global Impression - Improvement (CGI-I) score."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '255'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'Subject Uncooperative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Paliperidone ER', 'description': "Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator's discretion based upon participant's CGI-I score."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '221', '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': 353}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-25', 'studyFirstSubmitDate': '2012-04-12', 'resultsFirstSubmitDate': '2013-11-25', 'studyFirstSubmitQcDate': '2012-04-12', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-11-25', 'studyFirstPostDateStruct': {'date': '2012-04-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Responders as Per Clinical Global Impression - Improvement (CGI-I) Scale', 'timeFrame': 'Week 12', 'description': 'The CGI-I is a 7-point scale that requires the clinician to assess how much the participant\'s illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Responders were defined as participants evaluated as "1: very much improved" or "2: much improved" on the CGI-I scale at Week 12.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 12', 'timeFrame': 'Baseline, Week 12', '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". Higher scores indicate worsening.'}, {'measure': 'Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score', 'timeFrame': 'Week 12', 'description': "The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse."}, {'measure': 'Change From Baseline in Personal and Social Performance (PSP) Score at Week 12', 'timeFrame': 'Baseline, Week 12', '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 Drug Attitude Inventory (DAI-10) Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response (SR). A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive SR; a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Paliperidone Extended Release (ER)'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.', 'detailedDescription': 'This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale. Participants\' safety will also be monitored throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders \\[Edition 4\\] criteria)\n* Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening\n* Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)\n* Participants who are capable of and willing to fill out the questionnaire for themselves\n* Participants who are compliant with self-medication or can receive consistent help or support\n\nExclusion Criteria:\n\n* Participants with the past 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 allergy or hypersensitivity to risperidone or paliperidone\n* Participants who have taken clozapine, or have been exposed to the study drug within one month before screening\n* Participants who have been treated with the long acting antipsychotic injection within 28 days\n* Participants with significant risk including suicide or aggressive behavior'}, 'identificationModule': {'nctId': 'NCT01577160', 'briefTitle': 'A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Taiwan Ltd'}, 'officialTitle': 'An Open Label, Prospective, Non-Comparative Study to Evaluate Flexible Dose of Paliperidone ER and Clinical Response in the Treatment of Subjects With Schizophrenia', 'orgStudyIdInfo': {'id': 'CR015664'}, 'secondaryIdInfos': [{'id': 'R076477SCH4034', 'type': 'OTHER', 'domain': 'Johnson & Johnson Taiwan Ltd'}, {'id': 'PAL-TWN-MA2', 'type': 'OTHER', 'domain': 'Johnson & Johnson Taiwan Ltd'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paliperidone Extended Release (ER)', 'interventionNames': ['Drug: Paliperidone ER']}], 'interventions': [{'name': 'Paliperidone ER', 'type': 'DRUG', 'description': "Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.", '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'}}}}