Suicide, AttemptedNCT03116503
Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
A study testing diagnosis of bipolar disorder and comorbid depression in people with Suicide, Attempted, run by Fondation Lenval at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- diagnosis of bipolar disorder and comorbid depression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to Jun 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Refusal or impossibility of carrying out the KIDDIE-SADS questionnaire
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation Lenval, Hôpitaux pédiatriques de Nice CHU Lenval
Nice, 06200
About this study
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.
Read the detailed description
This study is a prospective, routine care, covering pediatric population suicidal (who attempted suicide) and suicide (with suicidal ideas with planning) hospitalized in the pediatric hospital in Nice- Lenval Hospital.
The main objective 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.
The secondary objectives are: 1) comparison of the suicide attempt rate of recurrence at 6 months and 12 months among subjects with a diagnosis of mood disorder (depression or bipolar) and subjects with a diagnosis mood disorder; 2) the identification of specific suicidal recurrence risk factors in the diagnosis of mood disorder; 3) comparing the diagnostic evaluation field (ICD-10 criteria) vs standardized assessment (DSM-5 criteria).
For this the investigator propose an observational cohort study, single center, on a trailing 12 months after inclusion.
The topics are selected and included consecutively over a period of 12 months. The inclusion criteria are: 1) children - teenagers age: 6-18 years inclusive; 2) hospitalization for suicide attempt or suicidal ideation with planning in the Pediatric Hospital of Nice Lenval Hospital; 3) French patients; 4) speaking parents 5) affiliation to the social security system.
The criterion for inclusion is not the refusal or failure to realize the Kiddie - SADS with the subject and / or his parents.
The number of subjects to be included is estimated at 100. At baseline: standardized assessment of comorbid psychiatric diagnosis according to DSM-5 Mood disorders according to DSM-IV R criteria for other diagnoses. The investigatorwill use the KIDDIE-SADS, semi-structured interview for diagnostic purposes adapted to the DSM for that assessment.
The patients were distributed into two groups: mood disorder group - group without mood disorder.
In parallel, the field team evaluates blind psychiatric diagnosis according to ICD-10 criteria.
The population included subjects is described: clinicaly - demographic - overall operation - individual and family psychiatric history.
The topics included are reassessed at 6 months and 12 months. At 6 months: occurrence of an attempted suicide or recurrence of suicidal thoughts with planning - overall operation - clinical condition. At 12 months: re standardized diagnostic evaluation with KIDDIE-SADS and re identical clinical evaluation at 6 months.
The recidivism risk factors and recidivism rates are evaluated in both groups. The primary endpoint of the study is the attempt recurrence rate of suicide.
- Conditions
- Suicide, Attempted
- Being tested
- diagnosis of bipolar disorder and comorbid depression
- Keywords
- Suicide
- Medical subject headings
- Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnosis of bipolar disorder and comorbid depressionOther
Evaluation of the number of diagnosis of bipolar disorder and comorbid depression
| Study group | Role | What they receive |
|---|---|---|
| bipolar disorder and comorbid depression | Experimental | number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population. Receives: Other: diagnosis of bipolar disorder and comorbid depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline during inclusion visit
Secondary outcomes (3)
recurrence rates
compare the recurrence rates at 6 and 12 months between bipolar and depressed patients and patients not diagnosed with a mood disorder
Measured: comparison between 6 month and 12 month
risk factors for suicidal recidivism
To compare the risk factors for suicidal recidivism between bipolar and depressed patients
Measured: At baseline during inclusion visit
comorbid diagnoses
Compare the comorbid diagnoses obtained by the standardized assessment (Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for mood disorders and DSM-IVR for other diagnoses) vs. field assessment (CIM-10) (Classification internationale des maladies-10)
Measured: At baseline during inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startJun 2016
- Primary completionJun 2018
- Study completionJun 2018
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.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie DUGAND, MD, Principal investigator, Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116503
- Sponsor's protocol ID
- 16-HPNCL-01
- Status last verified
- Apr 2017
- First submitted
- 21 Feb 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolarity - Depression in Children and Adolescent Suicide Attempters: Better Diagnosis to Prevent Recurrence
- ClinicalTrials.gov ID
- NCT03116503
- Acronym / sponsor ID
- 16-HPNCL-01
- Conditions
- Suicide, Attempted
- Keywords
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 17 Apr 2017 (actual)
- 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.
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.
Detailed description
This study is a prospective, routine care, covering pediatric population suicidal (who attempted suicide) and suicide (with suicidal ideas with planning) hospitalized in the pediatric hospital in Nice- Lenval Hospital.
The main objective 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.
The secondary objectives are: 1) comparison of the suicide attempt rate of recurrence at 6 months and 12 months among subjects with a diagnosis of mood disorder (depression or bipolar) and subjects with a diagnosis mood disorder; 2) the identification of specific suicidal recurrence risk factors in the diagnosis of mood disorder; 3) comparing the diagnostic evaluation field (ICD-10 criteria) vs standardized assessment (DSM-5 criteria).
For this the investigator propose an observational cohort study, single center, on a trailing 12 months after inclusion.
The topics are selected and included consecutively over a period of 12 months. The inclusion criteria are: 1) children - teenagers age: 6-18 years inclusive; 2) hospitalization for suicide attempt or suicidal ideation with planning in the Pediatric Hospital of Nice Lenval Hospital; 3) French patients; 4) speaking parents 5) affiliation to the social security system.
The criterion for inclusion is not the refusal or failure to realize the Kiddie - SADS with the subject and / or his parents.
The number of subjects to be included is estimated at 100. At baseline: standardized assessment of comorbid psychiatric diagnosis according to DSM-5 Mood disorders according to DSM-IV R criteria for other diagnoses. The investigatorwill use the KIDDIE-SADS, semi-structured interview for diagnostic purposes adapted to the DSM for that assessment.
The patients were distributed into two groups: mood disorder group - group without mood disorder.
In parallel, the field team evaluates blind psychiatric diagnosis according to ICD-10 criteria.
The population included subjects is described: clinicaly - demographic - overall operation - individual and family psychiatric history.
The topics included are reassessed at 6 months and 12 months. At 6 months: occurrence of an attempted suicide or recurrence of suicidal thoughts with planning - overall operation - clinical condition. At 12 months: re standardized diagnostic evaluation with KIDDIE-SADS and re identical clinical evaluation at 6 months.
The recidivism risk factors and recidivism rates are evaluated in both groups. The primary endpoint of the study is the attempt recurrence rate of suicide.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
| Arm | Type | Receives |
|---|---|---|
| bipolar disorder and comorbid depression | Experimental | Other: diagnosis of bipolar disorder and comorbid depressionnumber of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal or impossibility of carrying out the KIDDIE-SADS questionnaire
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 |
|---|---|---|
| diagnosis of bipolar disorder and comorbid depressionEvaluation of the number of diagnosis of bipolar disorder and comorbid depression | Other | bipolar disorder and comorbid depression |
Primary outcome
diagnosis of bipolar disorder and comorbid depression
Time frame: At baseline during inclusion visit
Describe the number of diagnosis of bipolar disorder and comorbid depression of suicidal behaviors in the pediatric population.
3 secondary outcomes
recurrence rates
Time frame: comparison between 6 month and 12 month
risk factors for suicidal recidivism
Time frame: At baseline during inclusion visit
comorbid diagnoses
Time frame: At baseline during inclusion visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Nathalie DUGAND, MD principal investigator
Fondation Lenval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnosis of bipolar disorder and comorbid depression in people with Suicide, Attempted, run by Fondation Lenval at 1 site 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
diagnosis of bipolar disorder and comorbid depression (time frame: At baseline during inclusion visit). 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 30 Jul 2018.