Clinical trial NCT03116503: Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
Official title: Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Keywords: Suicide
Lead sponsor: Fondation Lenval
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: Inclusion Criteria:

* hospitalized at Fondation Lenval/ pediatric hospital of Nice-CHU Lenval for suicide attempt and / or suicidal ideas with planning
* French-speaking patient
* Francophone parents
* Affiliation to asocial security system

Exclusion Criteria:

* Refusal or impossibility of carrying out the KIDDIE-SADS questionnaire

Primary outcomes:
measure: diagnosis of bipolar disorder and comorbid depression
timeFrame: At baseline during inclusion visit
Secondary outcomes:
measure: recurrence rates
timeFrame: comparison between 6 month and 12 month
measure: risk factors for suicidal recidivism
timeFrame: At baseline during inclusion visit
measure: comorbid diagnoses
timeFrame: At baseline during inclusion visit
Other outcomes:
Locations:
city: Nice
country: France
facility: Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval
Study officials:
affiliation: Fondation Lenval
name: Nathalie DUGAND, MD
role: PRINCIPAL_INVESTIGATOR
References: