Suicide, AttemptedACTIHUMEURNCT02803632
Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide
A study testing questionnaires and actigraphic recording in people with Suicide, Attempted, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- questionnaires and actigraphic recording
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Feb 2013to 24 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children/adolescents admitted after a suicide attempt
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Suicide, Attempted
- Being tested
- questionnaires, actigraphic recording
- Keywords
- young, disruptive mood dysregulation disorder, actigraphic profile
- Medical subject headings
- Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesBehavioural
actigraphic recordingDevice
| Study group | Role | What they receive |
|---|---|---|
| suicide attempt | Experimental | questionnaires actigraphic recording Receives: Behavioral: questionnaires; Device: actigraphic recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)
The variable absence / presence of the disruptive mood dysregulation disorder (DMDD)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start6 Feb 2013
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
Why it stopped: recruitment problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc GUILE, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803632
- Sponsor's protocol ID
- AOL11-DR -GUILE
- Acronym
- ACTIHUMEUR
- Status last verified
- Dec 2020
- First submitted
- 9 Jun 2016
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Actigraphic Profile of Young Patients Admitted for Attempted Suicide: Investigation of Disruptive Mood Dysregulation Disorder
- ClinicalTrials.gov ID
- NCT02803632
- Acronym / sponsor ID
- ACTIHUMEUR / AOL11-DR -GUILE
- Conditions
- Suicide, Attempted
- Keywords
- young, disruptive mood dysregulation disorder, actigraphic profile
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment problem
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Feb 2013 (actual)
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| suicide attempt | Experimental | Behavioral: questionnaires, Device: actigraphic recordingquestionnaires actigraphic recording |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children/adolescents admitted after a suicide attempt
Key exclusion criteria (8 listed)
- severe depression
- mental retardation
- pervasive developmental disorder
- active psychotic episode,
- drug and alcohol abuse at the time of admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaires | Behavioural | suicide attempt |
| actigraphic recording | Device | suicide attempt |
Primary outcome
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)
Results and safety
The study was stopped early (reason given: recruitment problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
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Suicide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Marc GUILE, PhD principal investigator
CHU Amiens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires and actigraphic recording in people with Suicide, Attempted, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment problem). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The variable absence / presence of the disruptive mood dysregulation disorder (DMDD) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.