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

NCT03026387 | Unknown

• 2 other identifiers: UF 96812016-A00845-46
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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:

1. 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. 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.

Conditions

Suicide Attempt

Keywords

Suicidal behavior; Suicide attempt; Emergency department; Psychometrics; Neuropsychological tests; Suicidal ideation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Score of a short scale of suicidal risk assessment

  12 months

• Intensity of suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

  12 months

• Characteristics of suicidal behaviors assessed by Columbia Suicide History Form and the Columbia Suicide Severity Rating Scale

  12 months

Study Arms (1)

Neuropsychological battery tests

OTHER

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

Behavioral: Neuropsychological battery tests

Interventions

Neuropsychological battery tests BEHAVIORAL

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.

Neuropsychological battery tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at least 18 years old
• 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

You may not qualify if:

• 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 who has already achieved 4500€ of annual research allowances

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• National Institute of Health and Medical Research 1061, Montpellier: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Suicide, Attempted; Emergencies; Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorge LOPEZ-CASTROMAN, MD

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge LOPEZ-CASTROMAN, MD

CONTACT

+33 4 66 68 34 26; jorge.lopezcastroman@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2017
• First Posted: January 20, 2017
• Study Start: May 5, 2017
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)