- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02803632
Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide (ACTIHUMEUR)
December 4, 2020 updated by: Centre Hospitalier Universitaire, Amiens
Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide: Investigation of Disruptive Mood Dysregulation Disorder
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Amiens, France, 80054
- CHU Amiens
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Paris, France, 75004
- AP HP
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: suicide attempt
questionnaires actigraphic recording
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)
Time Frame: Day 0
|
The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jean-Marc GUILE, PhD, CHU Amiens
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2013
Primary Completion (Actual)
August 24, 2018
Study Completion (Actual)
August 24, 2018
Study Registration Dates
First Submitted
June 9, 2016
First Submitted That Met QC Criteria
June 14, 2016
First Posted (Estimate)
June 17, 2016
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 4, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AOL11-DR -GUILE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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