Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-26 @ 10:20 AM
Study NCT ID:
NCT01376492
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2011-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FYS Study: Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 709}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-07', 'studyFirstSubmitDate': '2011-06-16', 'studyFirstSubmitQcDate': '2011-06-17', 'lastUpdatePostDateStruct': {'date': '2013-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Sleep disturbances', 'Quality of sleep', 'Functioning level', 'Antipsychotic therapy.'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the relationship between performance of patients with schizophrenia and relationship with perceived quality of sleep. The secondary objectives are: to establish the prevalence of schizophrenic patients reporting sleep disturbances; to assess the potential epidemiological risk factors associated with the perceived impairment of quality of sleep; to establish the relationship between the clinical condition and the quality of sleep perceived; to assess the performance level of patients.', 'detailedDescription': 'This is a multicenter, cross-sectional, epidemiological study in the daily clinical practice on the relationship between personal and social functionality and quality of sleep perceived in outpatients with schizophrenia. It is proposed to perform a simple screening for detecting schizophrenic patients reporting sleep disturbances. These patients will be assessed in a single visit and will be administered a number of quality of life and functional assessment scales. N/A'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with schizophrenia seen in outpatient mental health care facilities distributed all over the country, with and without sleep disturbances at the time of the visit.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient diagnosed of schizophrenia\n* reporting sleep disturbances at the time of the visit or patient not reporting sleep disturbances at the time of the visit\n* who are on stable antipsychotic therapy for at least 6 months prior to inclusion in the study\n* (or guardian/ legal representative) consenting to participate in the study by signing the written informed consent.\n\nExclusion Criteria:\n\n* Patient who, in the investigator's opinion, fails to keep an adequate cognitive ability to continue the study and complete the questionnaires\n* who has any type of severe sleep disturbances related to disorders of the patient other than schizophrenia (e.g., nightmares, nocturnal fears, restless leg syndrome)\n* or included in another clinical study or trial that can interfere with the normal control of the disease."}, 'identificationModule': {'nctId': 'NCT01376492', 'briefTitle': 'FYS Study: Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag, S.A.'}, 'officialTitle': 'Epidemiological, Multicentre, Cross-sectional Study in a Clinical Practice Environment, About the Relationship Between Functioning Status and the Quality of Sleep Perceived by Schizophrenic Outpatients in Spain', 'orgStudyIdInfo': {'id': 'CR017518'}, 'secondaryIdInfos': [{'id': 'R076477SCH4053', 'type': 'OTHER', 'domain': 'Janssen-Cilag S.A., Spain'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '001', 'description': 'Functioning assessment The functioning will be assessed with 2 scales (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)', 'interventionNames': ['Other: Functioning assessment']}, {'label': '002', 'description': 'Quality of sleep assessment The quality of sleep will be assessed with 2 scales (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)', 'interventionNames': ['Other: Quality of sleep assessment']}], 'interventions': [{'name': 'Functioning assessment', 'type': 'OTHER', 'description': 'The functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)', 'armGroupLabels': ['001']}, {'name': 'Quality of sleep assessment', 'type': 'OTHER', 'description': 'The quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)', 'armGroupLabels': ['002']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag, S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag, S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}