Clinical trial NCT03026387: Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies
Official title: Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide Attempt
Keywords: Suicidal behavior
Suicide attempt
Emergency department
Psychometrics
Neuropsychological tests
Suicidal ideation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: National Institute of Health and Medical Research 1061, Montpellier
First posted: 2017-01-20
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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. 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.

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.

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

Primary outcomes:
measure: Frequency of suicidal relapse according to aggressive impulsivity.
timeFrame: 12 months
Secondary outcomes:
measure: Score of a short scale of suicidal risk assessment
timeFrame: 12 months
measure: Intensity of suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: 12 months
measure: Characteristics of suicidal behaviors assessed by Columbia Suicide History Form and the Columbia Suicide Severity Rating Scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Jorge LOPEZ-CASTROMAN, MD
role: PRINCIPAL_INVESTIGATOR
References: