Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
Primary Purpose
Suicide, Attempted
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diagnosis of bipolar disorder and comorbid depression
Sponsored by
About this trial
This is an interventional screening trial for Suicide, Attempted focused on measuring 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
Sites / Locations
- Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bipolar disorder and comorbid depression
Arm Description
number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
Outcomes
Primary Outcome Measures
diagnosis of bipolar disorder and comorbid depression
Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
Secondary Outcome Measures
recurrence rates
compare the recurrence rates at 6 and 12 months between bipolar and depressed patients and patients not diagnosed with a mood disorder
risk factors for suicidal recidivism
To compare the risk factors for suicidal recidivism between bipolar and depressed patients
comorbid diagnoses
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03116503
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
Suicide
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bipolar disorder and comorbid depression
Arm Type
Experimental
Arm Description
number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
Intervention Type
Other
Intervention Name(s)
diagnosis of bipolar disorder and comorbid depression
Intervention Description
Evaluation of the number of diagnosis of bipolar disorder and comorbid depression
Primary Outcome Measure Information:
Title
diagnosis of bipolar disorder and comorbid depression
Description
Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
Time Frame
At baseline during inclusion visit
Secondary Outcome Measure Information:
Title
recurrence rates
Description
compare the recurrence rates at 6 and 12 months between bipolar and depressed patients and patients not diagnosed with a mood disorder
Time Frame
comparison between 6 month and 12 month
Title
risk factors for suicidal recidivism
Description
To compare the risk factors for suicidal recidivism between bipolar and depressed patients
Time Frame
At baseline during inclusion visit
Title
comorbid diagnoses
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)
Time Frame
At baseline during inclusion visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie DUGAND, MD
Organizational Affiliation
Fondation Lenval
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval
City
Nice
ZIP/Postal Code
06200
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
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