Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-01-02 @ 3:11 PM
Study NCT ID:
NCT03116503
Status:
COMPLETED
Last Update Posted:
2018-07-30
First Post:
2017-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013406', 'term': 'Suicide, Attempted'}, {'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-04-11', 'lastUpdatePostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnosis of bipolar disorder and comorbid depression', 'timeFrame': 'At baseline during inclusion visit', 'description': 'Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.'}], 'secondaryOutcomes': [{'measure': 'recurrence rates', 'timeFrame': 'comparison between 6 month and 12 month', 'description': 'compare the recurrence rates at 6 and 12 months between bipolar and depressed patients and patients not diagnosed with a mood disorder'}, {'measure': 'risk factors for suicidal recidivism', 'timeFrame': 'At baseline during inclusion visit', 'description': 'To compare the risk factors for suicidal recidivism between bipolar and depressed patients'}, {'measure': 'comorbid diagnoses', 'timeFrame': 'At baseline during inclusion visit', 'description': 'Compare the comorbid diagnoses obtained by the standardized assessment (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for mood disorders and DSM-IVR for other diagnoses) vs. field assessment (CIM-10) (Classification internationale des maladies-10)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Suicide'], 'conditions': ['Suicide, Attempted']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to describe the number of diagnosis of bipolar depression and comorbid suicidal behavior according to the diagnostic criteria of the DSM-5.', 'detailedDescription': 'This study is a prospective, routine care, covering pediatric population suicidal (who attempted suicide) and suicide (with suicidal ideas with planning) hospitalized in the pediatric hospital in Nice- Lenval Hospital.\n\nThe main objective of the study is to describe the number of diagnosis of bipolar depression and comorbid suicidal behavior according to the diagnostic criteria of the DSM-5.\n\nThe secondary objectives are: 1) comparison of the suicide attempt rate of recurrence at 6 months and 12 months among subjects with a diagnosis of mood disorder (depression or bipolar) and subjects with a diagnosis mood disorder; 2) the identification of specific suicidal recurrence risk factors in the diagnosis of mood disorder; 3) comparing the diagnostic evaluation field (ICD-10 criteria) vs standardized assessment (DSM-5 criteria).\n\nFor this the investigator propose an observational cohort study, single center, on a trailing 12 months after inclusion.\n\nThe topics are selected and included consecutively over a period of 12 months. The inclusion criteria are: 1) children - teenagers age: 6-18 years inclusive; 2) hospitalization for suicide attempt or suicidal ideation with planning in the Pediatric Hospital of Nice Lenval Hospital; 3) French patients; 4) speaking parents 5) affiliation to the social security system.\n\nThe criterion for inclusion is not the refusal or failure to realize the Kiddie - SADS with the subject and / or his parents.\n\nThe number of subjects to be included is estimated at 100. At baseline: standardized assessment of comorbid psychiatric diagnosis according to DSM-5 Mood disorders according to DSM-IV R criteria for other diagnoses. The investigatorwill use the KIDDIE-SADS, semi-structured interview for diagnostic purposes adapted to the DSM for that assessment.\n\nThe patients were distributed into two groups: mood disorder group - group without mood disorder.\n\nIn parallel, the field team evaluates blind psychiatric diagnosis according to ICD-10 criteria.\n\nThe population included subjects is described: clinicaly - demographic - overall operation - individual and family psychiatric history.\n\nThe topics included are reassessed at 6 months and 12 months. At 6 months: occurrence of an attempted suicide or recurrence of suicidal thoughts with planning - overall operation - clinical condition. At 12 months: re standardized diagnostic evaluation with KIDDIE-SADS and re identical clinical evaluation at 6 months.\n\nThe recidivism risk factors and recidivism rates are evaluated in both groups. The primary endpoint of the study is the attempt recurrence rate of suicide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalized at Fondation Lenval/ pediatric hospital of Nice-CHU Lenval for suicide attempt and / or suicidal ideas with planning\n* French-speaking patient\n* Francophone parents\n* Affiliation to asocial security system\n\nExclusion Criteria:\n\n* Refusal or impossibility of carrying out the KIDDIE-SADS questionnaire'}, 'identificationModule': {'nctId': 'NCT03116503', 'briefTitle': 'Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Lenval'}, 'officialTitle': 'Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence', 'orgStudyIdInfo': {'id': '16-HPNCL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bipolar disorder and comorbid depression', 'description': 'number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.', 'interventionNames': ['Other: diagnosis of bipolar disorder and comorbid depression']}], 'interventions': [{'name': 'diagnosis of bipolar disorder and comorbid depression', 'type': 'OTHER', 'description': 'Evaluation of the number of diagnosis of bipolar disorder and comorbid depression', 'armGroupLabels': ['bipolar disorder and comorbid depression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06200', 'city': 'Nice', 'country': 'France', 'facility': 'Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Nathalie DUGAND, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Lenval'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Lenval', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}