NCT02803632

Brief Summary

An excess suicide-related morbidity is observed among young people in the Picardie region, as reflected by the \> 100% occupation rate of the Amiens University Hospital Adolescent Medicine Unit

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

February 6, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2018

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

5.5 years

First QC Date

June 9, 2016

Last Update Submit

December 4, 2020

Conditions

Suicide, Attempted

Keywords

youngdisruptive mood dysregulation disorderactigraphic profile

Outcome Measures

Primary Outcomes (1)

  • The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)

    The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)

    Day 0

Study Arms (1)

suicide attempt

EXPERIMENTAL

questionnaires actigraphic recording

Behavioral: questionnairesDevice: actigraphic recording

Interventions

questionnairesBEHAVIORAL
suicide attempt
actigraphic recordingDEVICE
suicide attempt

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children/adolescents admitted after a suicide attempt

You may not qualify if:

  • severe depression
  • mental retardation
  • pervasive developmental disorder
  • active psychotic episode,
  • drug and alcohol abuse at the time of admission
  • organic sleep-wake disorders (sleep-related respiratory and motor disorders, narcolepsy)
  • any contraindication formulated by the clinical team
  • patients not covered by French national health insurance, patients deprived of their freedom as stipulated in Article L.1121-6 of the French Public Health Code

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Amiens

Amiens, 80054, France

Location

AP HP

Paris, 75004, France

Location

MeSH Terms

Conditions

Suicide, Attempted

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jean-Marc GUILE, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 17, 2016

Study Start

February 6, 2013

Primary Completion

August 24, 2018

Study Completion

August 24, 2018

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations

FR(2)