Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT00697658
Status:
COMPLETED
Last Update Posted:
2014-04-28
First Post:
2008-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-24', 'studyFirstSubmitDate': '2008-04-11', 'studyFirstSubmitQcDate': '2008-06-13', 'lastUpdatePostDateStruct': {'date': '2014-04-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in CGI-S score at the end of the study', 'timeFrame': 'Week 26 or drop out visit'}], 'secondaryOutcomes': [{'measure': 'Change in Health of the Nation Outcome Scales (HoNOS)', 'timeFrame': 'Week 26 or drop out visit'}, {'measure': 'Change in GAF score', 'timeFrame': 'Week 26 or drop out visit'}, {'measure': 'Patient satisfaction with treatment', 'timeFrame': 'Week 26 or drop out visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Paliperidone ER', 'Schizophrenia'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting.', 'detailedDescription': "This is an observational, prospective, multicenter 6-month study to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. The primary objective is to explore changes in Clinical Global Impression of Severity (CGI-S) score from baseline up to 26 weeks, in subgroups of schizophrenia patients who started treatment with paliperidone ER. Secondary objectives are: 1) To explore changes in mental health and social functioning based on routine outcome assessments in the Netherlands, the Health of the Nation Outcome Scales (HoNOS) and Global Assessment of Functioning (GAF), in schizophrenia patients who started treatment with paliperidone ER ; 2) To explore changes in patient's satisfaction with treatment, changes in number of ambulant contacts, changes in body weight, changes in concomitant therapy and to explore adverse events in schizophrenia patients who started treatment with paliperidone ER; and to explore possible association between CGI-S, GAF and HoNOS.\n\nThe patients will receive paliperidone ER (6 mg, 9 mg or other dosages as directed on the label) once daily for the period of 6 month. Which dosage of paliperidone ER the patients receive will be at the discretion of the investigator and according the Summary of Product Characteristics (SmPC). Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Schizophrenia patients meeting DSM-IV criteria receiving paliperidone ER, as part of the common practice of participating physicians. Patients may enter the study as soon as their paliperidone ER treatment starts or when it has been less than 14 days after their treatment start.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient meets the DSM-IV criteria for schizophrenia\n* Switched to or started on paliperidone ER, not longer than two weeks ago\n* In 24 hours before initiation of paliperidone ER treatment, CGI-S, patient satisfaction with treatment, concomitant therapy, body weight, GAF and HoNOS data are available\n* Patient or legal representative has signed the informed consent form within two weeks after starting treatment with paliperidone ER\n\nExclusion Criteria:\n\n* No use of paliperidone ER, clozapine, any conventional depot neuroleptic or long acting atypical antipsychotic drugs during 3 months before starting paliperidone ER\n* No participation in an investigational drug trial in 30 days prior to starting paliperidone ER\n* No history of neuroleptic malignant syndrome\n* No known hypersensitivity to paliperidone ER or risperidone\n* No patients hospitalized for a period longer than 12 weeks'}, 'identificationModule': {'nctId': 'NCT00697658', 'briefTitle': 'INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag B.V.'}, 'officialTitle': 'INVega Is Studied In an Observational Design in the Netherlands', 'orgStudyIdInfo': {'id': 'CR014788'}, 'secondaryIdInfos': [{'id': 'R076477SCH4017'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'interventionNames': ['Drug: Paliperidone ER']}], 'interventions': [{'name': 'Paliperidone ER', 'type': 'DRUG', 'description': '6 mg tablet once daily, variable treatment length.', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alphen aan den Rijn', 'country': 'Netherlands', 'geoPoint': {'lat': 52.12917, 'lon': 4.65546}}, {'city': 'Amersfoort', 'country': 'Netherlands', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Beverwijk', 'country': 'Netherlands', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}, {'city': 'Deventer', 'country': 'Netherlands', 'geoPoint': {'lat': 52.255, 'lon': 6.16389}}, {'city': 'Echt', 'country': 'Netherlands', 'geoPoint': {'lat': 51.10583, 'lon': 5.87361}}, {'city': 'Enschede', 'country': 'Netherlands', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Geldrop', 'country': 'Netherlands', 'geoPoint': {'lat': 51.42167, 'lon': 5.55972}}, {'city': 'Heerde', 'country': 'Netherlands', 'geoPoint': {'lat': 52.38723, 'lon': 6.04016}}, {'city': 'Heerenveen', 'country': 'Netherlands', 'geoPoint': {'lat': 52.95929, 'lon': 5.91854}}, {'city': 'Hoorn', 'country': 'Netherlands', 'geoPoint': {'lat': 52.6425, 'lon': 5.05972}}, {'city': 'Kampen', 'country': 'Netherlands', 'geoPoint': {'lat': 52.555, 'lon': 5.91111}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Purmerend', 'country': 'Netherlands', 'geoPoint': {'lat': 52.505, 'lon': 4.95972}}, {'city': 'Roermond', 'country': 'Netherlands', 'geoPoint': {'lat': 51.19417, 'lon': 5.9875}}, {'city': 'Vlaardingen', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9125, 'lon': 4.34167}}, {'city': 'Zwolle', 'country': 'Netherlands', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Janssen-Cilag B.V. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}