Trials / Completed
CompletedNCT03116503
Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Fondation Lenval · Academic / Other
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | diagnosis of bipolar disorder and comorbid depression | Evaluation of the number of diagnosis of bipolar disorder and comorbid depression |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2017-04-17
- Last updated
- 2018-07-30
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03116503. Inclusion in this directory is not an endorsement.