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Completed

NCT Number: NCT03116503

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval

Nice, 06200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diagnosis of bipolar disorder and comorbid depression

Other

Evaluation of the number of diagnosis of bipolar disorder and comorbid depression

Primary outcomes

  1. diagnosis of bipolar disorder and comorbid depression

    Time frame: At baseline during inclusion visit

    Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.

Secondary outcomes

  1. recurrence rates

    Time frame: comparison between 6 month and 12 month

    compare the recurrence rates at 6 and 12 months between bipolar and depressed patients and patients not diagnosed with a mood disorder

  2. risk factors for suicidal recidivism

    Time frame: At baseline during inclusion visit

    To compare the risk factors for suicidal recidivism between bipolar and depressed patients

  3. comorbid diagnoses

    Time frame: At baseline during inclusion visit

    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)

Sponsors and collaborators

Lead sponsor

Fondation Lenval

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 17, 2017
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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