Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies (SUI-PREDICT)

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide Attempt
• Intervention / Treatment: Behavioral: Neuropsychological battery tests

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.

• Study Type: Interventional
• Enrollment (Anticipated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge LOPEZ-CASTROMAN, MD; Phone Number: +33 4 66 68 34 26; Email: jorge.lopezcastroman@chu-nimes.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • Montpellier University Hospital
    • Contact: Catherine GENTY, MD; Phone Number: +33 4 67 99 61 45 75; Email: c-genty@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Neuropsychological battery tests; All participants performed the same evaluation: clinical and neuropsychological assessment. All of them are suicide attempters without psychotic features

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: National Institute of Health and Medical Research 1061, Montpellier
• Investigators: Principal Investigator: Jorge LOPEZ-CASTROMAN, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Anticipated): October 1, 2024
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: January 17, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 20, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Suicidal behavior; Emergency department; Psychometrics; Suicidal ideation; Suicide attempt; Neuropsychological tests
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Self-Injurious Behavior; Emergencies; Suicide; Suicide, Attempted; Impulsive Behavior
• Other Study ID Numbers: UF 9681; 2016-A00845-46 (Other Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No