Suicide AttemptSUI-PREDICTNCT03026387
Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies
A study testing Neuropsychological battery tests in people with Suicide Attempt, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Attempt
- What is being tested?
- Neuropsychological battery tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2017to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, 34295
Catherine GENTY, MD, +33 4 67 99 61 45 75, c-genty@chu-montpellier.fr
About this study
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.
Read the 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.
- Conditions
- Suicide Attempt
- Being tested
- Neuropsychological battery tests
- Keywords
- Suicidal behavior, Suicide attempt, Emergency department, Psychometrics, Neuropsychological tests, Suicidal ideation
- Medical subject headings
- Suicide, Attempted, Emergencies, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological battery testsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuropsychological battery tests | Other | All participants performed the same evaluation: clinical and neuropsychological assessment.
All of them are suicide attempters without psychotic features Receives: Behavioral: Neuropsychological battery tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start5 May 2017
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health and Medical Research 1061, Montpellier
- Responsible party
- Sponsor
- Investigators
- Jorge LOPEZ-CASTROMAN, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026387
- Sponsor's protocol ID
- UF 9681
- Other IDs
- 2016-A00845-46
- Acronym
- SUI-PREDICT
- Status last verified
- Sep 2022
- First submitted
- 17 Jan 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies
- ClinicalTrials.gov ID
- NCT03026387
- Acronym / sponsor ID
- SUI-PREDICT / UF 9681
- Conditions
- Suicide Attempt
- Keywords
- Suicidal behavior, Suicide attempt, Emergency department, Psychometrics, Neuropsychological tests, Suicidal ideation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- National Institute of Health and Medical Research 1061, Montpellier
- Study start
- 5 May 2017 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuropsychological battery tests | Other | Behavioral: Neuropsychological battery testsAll participants performed the same evaluation: clinical and neuropsychological assessment. All of them are suicide attempters without psychotic features |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological battery testsThe 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. | Behavioural | Neuropsychological battery tests |
Primary outcome
Frequency of suicidal relapse according to aggressive impulsivity.
Time frame: 12 months
aggressive impulsivity will be assessed by the capacity to inhibit responses during a Continuous Performance Task (CPT)
3 secondary outcomes
Score of a short scale of suicidal risk assessment
Time frame: 12 months
Intensity of suicidal ideation assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 12 months
Characteristics of suicidal behaviors assessed by Columbia Suicide History Form and the Columbia Suicide Severity Rating Scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge LOPEZ-CASTROMAN, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological battery tests in people with Suicide Attempt, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge LOPEZ-CASTROMAN, MD (+33 4 66 68 34 26, jorge.lopezcastroman@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of suicidal relapse according to aggressive impulsivity. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.