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Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide (ACTIHUMEUR)

Primary Purpose

Suicide, Attempted

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
questionnaires
actigraphic recording
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide, Attempted focused on measuring young, disruptive mood dysregulation disorder, actigraphic profile

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • children/adolescents admitted after a suicide attempt

Exclusion Criteria:

  • 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

Sites / Locations

  • CHU Amiens
  • AP HP

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

suicide attempt

Arm Description

questionnaires actigraphic recording

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 9, 2016
Last Updated
December 4, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02803632
Brief Title
Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide
Acronym
ACTIHUMEUR
Official Title
Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide: Investigation of Disruptive Mood Dysregulation Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
recruitment problem
Study Start Date
February 6, 2013 (Actual)
Primary Completion Date
August 24, 2018 (Actual)
Study Completion Date
August 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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. New approaches have been proposed to these problems that have led us to reorganize our diagnostic practices: 1) more precise characterization of suicidal behaviour by using standardized instruments such as the French version of the Columbia-Suicide Severity Rating Scale developed by Posner (C-SSRS); 2) new clinical entities, such as disruptive mood dysregulation disorder, are now proposed in international classifications (DSM 5 field trial); 3) investigations such as recording of the circadian rhythm of motor activity by actigraphy are being studied as a laboratory complement to psychiatric diagnosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
young, disruptive mood dysregulation disorder, actigraphic profile

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
suicide attempt
Arm Type
Experimental
Arm Description
questionnaires actigraphic recording
Intervention Type
Behavioral
Intervention Name(s)
questionnaires
Intervention Type
Device
Intervention Name(s)
actigraphic recording
Primary Outcome Measure Information:
Title
The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)
Description
The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: children/adolescents admitted after a suicide attempt Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc GUILE, PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
AP HP
City
Paris
ZIP/Postal Code
75004
Country
France

12. IPD Sharing Statement

Learn more about this trial

Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide

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