NCT03116503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 30, 2018

Status Verified

April 1, 2017

Enrollment Period

2 years

First QC Date

February 21, 2017

Last Update Submit

July 27, 2018

Conditions

Suicide, Attempted

Keywords

Suicide

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • recurrence rates

    comparison between 6 month and 12 month

  • risk factors for suicidal recidivism

    At baseline during inclusion visit

  • comorbid diagnoses

    At baseline during inclusion visit

Study Arms (1)

bipolar disorder and comorbid depression

EXPERIMENTAL

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

Other: diagnosis of bipolar disorder and comorbid depression

Interventions

diagnosis of bipolar disorder and comorbid depressionOTHER

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

bipolar disorder and comorbid depression

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval

Nice, 06200, France

Location

MeSH Terms

Conditions

Suicide, AttemptedSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Nathalie DUGAND, MD

    Fondation Lenval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

April 17, 2017

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

July 30, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)