Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies

Suicide Attempt Clinical Trial

— SUI-PREDICT  

Official title:

Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03026387
• Other study ID #: UF 9681
• Secondary ID: 2016-A00845-46
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: October 2024

Study information

• Verified date: September 2022
• Source: University Hospital, Montpellier
• Contact: Jorge LOPEZ-CASTROMAN, MD
• Phone: +33 4 66 68 34 26
• Email: jorge.lopezcastroman[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

1. 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.

2. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Impulsive Behavior
• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

Behavioral:
• Neuropsychological battery tests
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.

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	National Institute of Health and Medical Research 1061, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 months
Secondary	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.	12 months
Secondary	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	12 months
Secondary	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	12 months