Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-04 @ 5:11 PM
Study NCT ID:
NCT05843357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2023-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PAPSY - Memory in Psychiatry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-13', 'studyFirstSubmitDate': '2023-03-15', 'studyFirstSubmitQcDate': '2023-04-24', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline ALBA', 'timeFrame': 'Established on Day 0 as a single assessment.', 'description': 'Amnesia Light and Brief Assessment (ALBA) test is an innovative method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-12 (a lower value denotes a more severe cognitive impairment).'}, {'measure': 'Baseline PICNIR', 'timeFrame': 'Established on Day 0 as a single assessment.', 'description': 'Picture Naming and Immediate Recall test (PICNIR) is an innovative test method to assess cognitive functions quickly. The cognitive performance is scaled as an overall score between 0-20 (a lower value denotes a more severe cognitive impairment).'}, {'measure': 'Statistical analysis of ALBA results,', 'timeFrame': 'The final statistical analysis will be performed through study completion, an average of 6 months.', 'description': 'Statistical analysis of ALBA results compared to groups determined by ICD-10 diagnosis and demographical data.'}, {'measure': 'Statistical analysis of PICNIR results.', 'timeFrame': 'The final statistical analysis will be performed through study completion, an average of 6 months.', 'description': 'Statistical analysis of PICNIR results compared to groups determined by ICD-10 diagnosis and demographical data.'}], 'secondaryOutcomes': [{'measure': 'Baseline MBI-C-CZ', 'timeFrame': 'Established as a baseline on Day 0.', 'description': 'Mild Behavioral Impairment - Checklist - Czech version (MBI-C-CZ) is a standardized questionnaire to assess behavioral impairment in 34 items. Each item is scaled between 0-3 (a higher value denotes a higher severity) to reach the overall score between 0-102 (a higher value denotes a higher overall severity of behavioral impairments)'}, {'measure': 'Baseline sFAQ-CZ', 'timeFrame': 'Established as a baseline on Day 0.', 'description': 'Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for participants´ self-evaluation.'}, {'measure': 'Baseline GDS-CZ', 'timeFrame': 'Established as a baseline on Day 0.', 'description': 'The Geriatric Depression Scale - Czech version (GDS-CZ) is a standardized questionnaire administered to assess depressive symptoms, particularly in the elderly population. Fifteen items are scaled between 0-1 to reach the overall score between 0-15 (a higher value denotes a higher level of depressive symptoms).'}, {'measure': 'Baseline oFAQ-CZ', 'timeFrame': 'Established as a baseline on Day 0.', 'description': 'Functional Activities Questionnaire - Czech version (FAQ-CZ) is a standardized questionnaire administered to assess a patient´s functional state regarding daily activities. Ten items of daily functioning are scaled between 0-3 (a higher value denotes a higher dependency) to reach the overall score between 0-30 (a higher value denotes a higher dependency). This version of the scale will be used for caretakers´ evaluation of participants´ functioning.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Impairment', 'Outpatient Psychiatric Service', 'Population Distribution'], 'conditions': ['Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "Memory in Psychiatry project (PAPSY) aims to map the distribution and severity of cognitive impairment in patients of outpatient psychiatric offices across the geographical area of the Czech Republic. 1000 patients in 90 psychiatric offices will undergo cognitive tests (ALBA and PICNIR) and psychometric scales (sFAQ-CZ and GDS-CZ) to asses their functional state and depressive symptoms. If applicable, caretakers will also be asked about the extent of the participant's autonomy and behavioral impairment (using oFAQ-CZ and MBI-C-CZ scales).\n\nThe trial's primary goal is to assess the distribution of cognitive impairment among diagnostic groups in psychiatric care according to the ICD-10. Additionally, the feasibility of ALBA and PICNIR methods to uncover previously undiagnosed cognitive impairments will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population is intended to be comprised of persons (45yrs+) living in the geographical area of the Czech Republic undergoing a treatment at an outpatient psychiatric office for a diagnosis defined in ICD-10 (excluding mental retardation). The probability sample will be created by a random selection of persons undergoing their regular outpatient psychiatric checkups.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dispensarization of at least six months in an outpatient psychiatric office with an ICD-10 diagnosis\n* Age\\>=45\n* Permanent residency in the geographical area of the Czech Republic\n\nExclusion Criteria:\n\n* Diagnosis of mental retardation (F70-F79) according to ICD-10\n* Refusal to sign the informed consent and consent with GDPR\n* Uncorrected visual impairment\n* Uncorrected auditory impairment\n* Inability to participate in the project'}, 'identificationModule': {'nctId': 'NCT05843357', 'acronym': 'PAPSY', 'briefTitle': 'PAPSY - Memory in Psychiatry', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'PAPSY: Snadné zjištění Poruch paměti pomocí Velmi krátkých testů ALBA a POBAV u psychiatrických diagnóz v celé ČR', 'orgStudyIdInfo': {'id': 'PAPSY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observed group', 'description': 'No intervention will be administered on behalf of the project. The participants will be tested using ALBA and PICNIR (non-invasive) cognitive tests, and further sFAQ-CZ and GDS-CZ questionnaires will be administered. Questionnaires FAQ-CZ and MBI-C-CZ will be distributed to participants´ caretakers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Prague', 'state': 'Prague', 'country': 'Czechia', 'facility': 'Teaching Hospital Královské Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Aleš Bartoš, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Czech Republic'}, {'name': 'Tadeáš Mareš, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles University, Czech Republic'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Upon the final publication of the outcomes, indefinitely.', 'ipdSharing': 'YES', 'description': 'IPD is to be shared upon request by a verified researcher. The study director´s discretion is reserved.', 'accessCriteria': 'Being a verified researcher.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultation-liaison psychiatrist', 'investigatorFullName': 'Tadeáš Mareš', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}