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:
Fondation Lenval
Organization:
Study Overview
Official Title:
Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: