Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies (SUI-PREDICT)
Primary Purpose
Suicide Attempt
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological battery tests
Sponsored by
About this trial
This is an interventional other trial for Suicide Attempt focused on measuring Suicidal behavior, Suicide attempt, Emergency department, Psychometrics, Neuropsychological tests, Suicidal ideation
Eligibility Criteria
Inclusion Criteria:
- Being at least 18 years old
- Have committed a suicide attempt within 7 days prior to inclusion
- Receive minimal treatment (assessed by the clinician)
- Sign the informed consent
- Be able to understand the nature, the aims and the methodology of the study
Exclusion Criteria:
- Patient with an actual or past history of psychotic disorder
- Patient not affiliated to a French social security system.
- Patient deprived of liberty (judicial or administrative decision)
- Patient aged 65 years or older with an MMSE score <24 at baseline.
- Patient in exclusion period after participation in another project
- Patient who has already achieved 4500€ of annual research allowances
Sites / Locations
- Montpellier University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Neuropsychological battery tests
Arm Description
All participants performed the same evaluation: clinical and neuropsychological assessment. All of them are suicide attempters without psychotic features
Outcomes
Primary Outcome Measures
Frequency of suicidal relapse according to aggressive impulsivity.
aggressive impulsivity will be assessed by the capacity to inhibit responses during a Continuous Performance Task (CPT)
Secondary Outcome Measures
Score of a short scale of suicidal risk assessment
We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse.
Intensity of suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse
Characteristics of suicidal behaviors assessed by Columbia Suicide History Form and the Columbia Suicide Severity Rating Scale
We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse
Full Information
NCT ID
NCT03026387
First Posted
January 17, 2017
Last Updated
September 26, 2022
Sponsor
University Hospital, Montpellier
Collaborators
National Institute of Health and Medical Research 1061, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03026387
Brief Title
Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies
Acronym
SUI-PREDICT
Official Title
Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
National Institute of Health and Medical Research 1061, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime SA. In addition, SBs are common among young people and are the second leading cause of death among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of predictive models. These are currently imprecise and prevent the development of consensual recommendations for the management of suicidal patients.
Most suicide attempters are evaluated in the emergency room where it is imperative to identify people with a high risk of relapse. Risk assessment is generally based on the experience of the practitioner who uses psychometric scales as support for clinical decisions. This assessment could be improved and supplemented by other sources of information. Thus, we aim to develop a short and specific tool that combines:
Neurocognitive measures carried out using computer software on domains strongly associated with SB: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention and verbal fluency.
Clinical and psychological assessment including the most predictive items of future SA: life events (environment) and personality traits (vulnerability). Suicide attempters will be assessed for SB and suicidal ideation in the emergency department. These measures will be repeated during a 12-month follow-up. We will use the data obtained to provide a more accurate measure of risk.
Detailed Description
Over 65 months, 5 emergency departments (Montpellier, Nimes, Uzès, Nice, Marseille) will recruit a total of 650 patients who attempted suicide.
First visit: clinical and neuropsychological assessment
Second and third visits at 6 and 12 months: assessment of SBs and suicidal relapse, clinical and neuropsychological assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Attempt
Keywords
Suicidal behavior, Suicide attempt, Emergency department, Psychometrics, Neuropsychological tests, Suicidal ideation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
650 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neuropsychological battery tests
Arm Type
Other
Arm Description
All participants performed the same evaluation: clinical and neuropsychological assessment.
All of them are suicide attempters without psychotic features
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological battery tests
Intervention Description
The neuropsychological battery tests is composed with: Continuous Performance Test, Iowa Gambling Test, Verbal fluency (animals), Emotional stroop, Self-injury implicit association test and N-back test.
The neuropsychological battery assesses domains heavily involved in suicidal behavior: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention,verbal fluidity and working memory.
Primary Outcome Measure Information:
Title
Frequency of suicidal relapse according to aggressive impulsivity.
Description
aggressive impulsivity will be assessed by the capacity to inhibit responses during a Continuous Performance Task (CPT)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Score of a short scale of suicidal risk assessment
Description
We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse.
Time Frame
12 months
Title
Intensity of suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse
Time Frame
12 months
Title
Characteristics of suicidal behaviors assessed by Columbia Suicide History Form and the Columbia Suicide Severity Rating Scale
Description
We aim to identify predictive factors of the occurrence of suicidal behavior in a non-psychotic suicidal population, in order to develop a battery of short-term tests applicable to emergencies. This short term tests will allow to establish a multidimensional score for the prediction of the risk of relapse
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being at least 18 years old
Have committed a suicide attempt within 7 days prior to inclusion
Receive minimal treatment (assessed by the clinician)
Sign the informed consent
Be able to understand the nature, the aims and the methodology of the study
Exclusion Criteria:
Patient with an actual or past history of psychotic disorder
Patient not affiliated to a French social security system.
Patient deprived of liberty (judicial or administrative decision)
Patient aged 65 years or older with an MMSE score <24 at baseline.
Patient in exclusion period after participation in another project
Patient who has already achieved 4500€ of annual research allowances
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge LOPEZ-CASTROMAN, MD
Phone
+33 4 66 68 34 26
Email
jorge.lopezcastroman@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge LOPEZ-CASTROMAN, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine GENTY, MD
Phone
+33 4 67 99 61 45 75
Email
c-genty@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies
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