Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence

Suicide, Attempted Clinical Trial

Official title:

Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03116503
• Other study ID #: 16-HPNCL-01
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: April 2017
• Source: Fondation Lenval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Recurrence
• Suicide
• Suicide, Attempted

Intervention

Other:
• diagnosis of bipolar disorder and comorbid depression
Evaluation of the number of diagnosis of bipolar disorder and comorbid depression

Locations

Country	Name	City	State
France	Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Lenval

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline during inclusion visit
Secondary	recurrence rates	compare the recurrence rates at 6 and 12 months between bipolar and depressed patients and patients not diagnosed with a mood disorder	comparison between 6 month and 12 month
Secondary	risk factors for suicidal recidivism	To compare the risk factors for suicidal recidivism between bipolar and depressed patients	At baseline during inclusion visit
Secondary	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)	At baseline during inclusion visit