Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT01968161
Status:
UNKNOWN
Last Update Posted:
2014-01-09
First Post:
2013-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigator Initiated Study - Asenapine Early Psychosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522667', 'term': 'asenapine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-08', 'studyFirstSubmitDate': '2013-10-16', 'studyFirstSubmitQcDate': '2013-10-22', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of switching to asenapine', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Predictors of successful switch to asenapine', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Schizophrenia and Disorders With Psychotic Features', 'Disorders']}, 'descriptionModule': {'briefSummary': 'We propose a use of a unique facility, the databank at the CNDV, to examine the impact of switching subjects to asenapine in an open-label naturalistic setting. This offers the following advantages: i) providing data on a particularly important population, i.e., subjects who are at the inception of treatment for a psychotic disorder and who are likely to remain on a given drug on a long-term basis; ii) its inclusion in a rich clinical setting, with a clinical team dedicated to provide innovative interventions; iii) its naturalistic design, that will allow to obtain data that will be applicable to "real-life" clinical settings; indeed, subjects who will be switched to asenapine within the current project are those we would switch to this drug in our daily practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meeting DSM-IV criteria for schizophrenia (SZ) or related SZ spectrum psychotic disorders\n* having provided a consent to include data on our databank,and being able to provide informed consent\n* willingness to participate to the assessments\n* being over 18 years of age\n* being in a clinical situation that warrants switch to asenapine\n\nExclusion Criteria:\n\n* suffering from a primary drug-induced psychosis\n* being at significant risk for suicide or assault\n* unstable medical condition\n* persistence of psychotic symptoms despite adequate treatment to an extent that clozapine would be required\n* being treated with antipsychotic for 5 years or more\n* having contraindications(allergy to asenapine)\n* being pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01968161', 'briefTitle': 'Investigator Initiated Study - Asenapine Early Psychosis', 'organization': {'class': 'OTHER', 'fullName': "Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec"}, 'officialTitle': 'An Open-label Switch Study to Asenapine in the Early Stage of Psychosis', 'orgStudyIdInfo': {'id': 'IIS - Switch Asenapine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Asenapine', 'description': 'Open label switch to asenapine: asenapine will be introduced at the target dose (5 mg bid)', 'interventionNames': ['Drug: Asenapine']}], 'interventions': [{'name': 'Asenapine', 'type': 'DRUG', 'armGroupLabels': ['Asenapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1K 4B2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'contacts': [{'name': 'Diana Pasat, BSc', 'role': 'CONTACT', 'email': 'diana.pasat@yahoo.ca', 'phone': '418-694-2223'}, {'name': 'Marc-Andre Roy, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinique Notre-Dame des Victoires', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Marc-André Roy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}