Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-03-01 @ 2:46 AM
Study NCT ID:
NCT02625818
Status:
COMPLETED
Last Update Posted:
2024-11-21
First Post:
2015-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Genetic and Affective Prediction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples (plasma and serum)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2021-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-18', 'studyFirstSubmitDate': '2015-12-04', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self-inflicted, potentially injurious behavior with intention to die defined as acts needing attendance by physician', 'timeFrame': '2 weeks', 'description': 'during in-patient stay'}], 'secondaryOutcomes': [{'measure': 'suicide', 'timeFrame': '2 years after discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emergency Services, Psychiatric', 'Prognosis', 'Biological markers', 'Anxiety', 'Panic', 'Psychomotor Agitation', 'Self-injurious Behavior'], 'conditions': ['Mental Disorders']}, 'descriptionModule': {'briefSummary': 'A major proportion of patients admitted to psychiatric acute and emergency departments have symptoms, behaviors or function influenced by implicit or explicit suicidal intention (tendency towards self-harm, or suicide attempt). There is an increased risk of suicide in the acute phase during in-patient stay and after discharge. At present there is no satisfactory tool to predict post-discharge suicide risk.\n\nMultidimensional rating is expected to have better predictive properties than one-dimensional rating for suicidal behavior during in -patient stay and two years after discharge. Multidimensional rating assesses anxiety, panic, agitation, suicidal thoughts and ideations, as well as therapist\'s reactions during interviews. In the present study the predictive properties of two rating scales for suicidal behavior during in-patient stay and two years after will be compared. One of these is a multidimensional scale: "Multidimensional Assessment of Suicide Risk" (MARIS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the psychiatric acute department for central Norway, St Olavs University Hospital, Trondheim. The department has a catchment area of approximately 240000 inhabitants ≥ 18 years. The hospital has close to 2000 admittances each year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute agitated condition\n* informed consent\n\nExclusion Criteria:\n\n* Drug abuse\n* in-patient stay for a fixed time at regular intervals'}, 'identificationModule': {'nctId': 'NCT02625818', 'acronym': 'GAP', 'briefTitle': 'The Genetic and Affective Prediction Study', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'The Genetic and Affective Prediction Study', 'orgStudyIdInfo': {'id': '2014/1751'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute psychiatric condition'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital, Østmarka psychiatric department', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Randolf Terje Vågen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St Olavs Hospital, Division of Mental Health Care'}, {'name': 'Nanna Sønnichsen Kayed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Mental Health, Faculty of Medicine and Health, NTNU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}