Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-28 @ 4:18 PM
Study NCT ID:
NCT02803632
Status:
TERMINATED
Last Update Posted:
2020-12-08
First Post:
2016-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013406', 'term': 'Suicide, Attempted'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'whyStopped': 'recruitment problem', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2016-06-09', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)', 'timeFrame': 'Day 0', 'description': 'The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['young', 'disruptive mood dysregulation disorder', 'actigraphic profile'], 'conditions': ['Suicide, Attempted']}, 'descriptionModule': {'briefSummary': 'An excess suicide-related morbidity is observed among young people in the Picardie region, as reflected by the \\> 100% occupation rate of the Amiens University Hospital Adolescent Medicine Unit', 'detailedDescription': 'An excess suicide-related morbidity is observed among young people in the Picardie region, as reflected by the \\> 100% occupation rate of the Amiens University Hospital Adolescent Medicine Unit. New approaches have been proposed to these problems that have led us to reorganize our diagnostic practices: 1) more precise characterization of suicidal behaviour by using standardized instruments such as the French version of the Columbia-Suicide Severity Rating Scale developed by Posner (C-SSRS); 2) new clinical entities, such as disruptive mood dysregulation disorder, are now proposed in international classifications (DSM 5 field trial); 3) investigations such as recording of the circadian rhythm of motor activity by actigraphy are being studied as a laboratory complement to psychiatric diagnosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children/adolescents admitted after a suicide attempt\n\nExclusion Criteria:\n\n* severe depression\n* mental retardation\n* pervasive developmental disorder\n* active psychotic episode,\n* drug and alcohol abuse at the time of admission\n* organic sleep-wake disorders (sleep-related respiratory and motor disorders, narcolepsy)\n* any contraindication formulated by the clinical team\n* patients not covered by French national health insurance, patients deprived of their freedom as stipulated in Article L.1121-6 of the French Public Health Code'}, 'identificationModule': {'nctId': 'NCT02803632', 'acronym': 'ACTIHUMEUR', 'briefTitle': 'Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide: Investigation of Disruptive Mood Dysregulation Disorder', 'orgStudyIdInfo': {'id': 'AOL11-DR -GUILE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'suicide attempt', 'description': 'questionnaires actigraphic recording', 'interventionNames': ['Behavioral: questionnaires', 'Device: actigraphic recording']}], 'interventions': [{'name': 'questionnaires', 'type': 'BEHAVIORAL', 'armGroupLabels': ['suicide attempt']}, {'name': 'actigraphic recording', 'type': 'DEVICE', 'armGroupLabels': ['suicide attempt']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'AP HP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean-Marc GUILE, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}