Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
NCT ID: NCT03116503
Last Updated: 2018-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
58 participants
INTERVENTIONAL
2016-06-30
2018-06-30
Brief Summary
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Detailed Description
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The 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.
The 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).
For this the investigator propose an observational cohort study, single center, on a trailing 12 months after inclusion.
The 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.
The criterion for inclusion is not the refusal or failure to realize the Kiddie - SADS with the subject and / or his parents.
The 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.
The patients were distributed into two groups: mood disorder group - group without mood disorder.
In parallel, the field team evaluates blind psychiatric diagnosis according to ICD-10 criteria.
The population included subjects is described: clinicaly - demographic - overall operation - individual and family psychiatric history.
The 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.
The recidivism risk factors and recidivism rates are evaluated in both groups. The primary endpoint of the study is the attempt recurrence rate of suicide.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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bipolar disorder and comorbid depression
number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
diagnosis of bipolar disorder and comorbid depression
Evaluation of the number of diagnosis of bipolar disorder and comorbid depression
Interventions
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diagnosis of bipolar disorder and comorbid depression
Evaluation of the number of diagnosis of bipolar disorder and comorbid depression
Eligibility Criteria
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Inclusion Criteria
* French-speaking patient
* Francophone parents
* Affiliation to asocial security system
Exclusion Criteria
6 Years
18 Years
ALL
No
Sponsors
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Fondation Lenval
OTHER
Responsible Party
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Principal Investigators
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Nathalie DUGAND, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Lenval
Locations
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Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval
Nice, , France
Countries
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Other Identifiers
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16-HPNCL-01
Identifier Type: -
Identifier Source: org_study_id
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