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SuicideSURAYANCT03538197

Suicide Re Attempts in Young Adults After First Suicide Attempt : Socio-demographic, Clinical and Biological Correlates

A study testing clinical and biological correlates in people with Suicide, run by Hôpital le Vinatier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Suicide is the second leading cause of death among people aged 15 to 24 (WHO, 2014). After a first suicide attempt, the 18 to 25 years old would be very likely to repeat the act: 25 to 31% would make a new attempt in the following year (Christiansen et al, 2007). Read more about this study

Who is it for?
Ages 18 to 25 years
Conditions the study is for
Suicide
What is being tested?
clinical and biological correlates
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteFrance
Study dates
22 May 2018to 29 Jun 2022
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 to 25 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • between the ages of 18 and 25
  • a first suicide attempt
  • Master French sufficient

Who cannot join

  • Majors protected: under curatorship or under guardianship

Trial locations and contacts

1 site in 1 country.

France1 site
  • Centre Hospitalier Le Vinatier

    Bron, AURA, 69678 CEDEX

Other trials in France

About this study

Official title: SURAYA : Suicide Re Attempts in Young Adults After First Suicide Attempt : Socio-demographic, Clinical and Biological Correlates

Suicide is the second leading cause of death among people aged 15 to 24 (WHO, 2014). After a first suicide attempt, the 18 to 25 years old would be very likely to repeat the act: 25 to 31% would make a new attempt in the following year (Christiansen et al, 2007).

Nevertheless the literature on this subject is not detailed. In this project, we hypothesize that young adults aged 18 to 25 who have made their first suicide attempt will repeat their act more frequently than younger or older populations. In addition, these young people would have identifiable risk factors (sociodemographic, clinical and biological) that differ from young people who do not enter this phenomenon.

Read more

Our main objective is to measure the rate of suicidal reiteration in a population of young adults aged 18 to 25 years.

Our secondary objectives are to identify sociodemographic, clinical and biological characteristics of a population of suicidal re attempt young people, to highlight potential risk factors

Read the detailed description

Objectives:

  • Our main objective is to measure the rate of suicidal re attempt (SR) in a population of young adults aged 18 to 25 years.
  • Our secondary objectives are to identify sociodemographic, clinical and biological characteristics of a population of suicidal young people, in an attempt to highlight potential risk factors. We will try to highlight correlations between the reiteration of the suicidal act and:
  1. socio-demographic criteria: level of urbanity, socio-economic level, social and family context, date and place of birth, religion, sexual orientation, name and contact details of the general practitioner, previous access to care
  2. scores on the scales of various psychiatric pathologies, existing or in formation (eg depression, anxiety disorders, psychosis)
  3. alterations at the peripheral level
  • on the stress response system: cortisolemia and capillary cortisol levels
  • on the total and mature serum BDNF

In addition, DNA and RNA genetic samples will be taken in order to constitute a biological collection for later research.

Type of study: This is an interventional research with minimal risks and constraints (2 ° study), multicenter prospective cohort.

Number of centers: 2 Suicide Prevention Center at the Le Vinatier Hospital Center and the Post Crisis Unit at the Edouard Herriot Hospital of the Hospices Civils de Lyon.

Description of the study / experimental plan:

This is a prospective cohort study that will be divided into two groups: "repeat suicide attempt" and "no repeat attempt"

Primary judgment criterion:

This is the occurrence of repeating a suicide attempt (over a period of 3 months after the initial attempt.

In this project, a suicide attempt is defined according to WHO criteria as "non-fatal suicidal behavior, self-inflicted injury with a desire to end one's life that does not lead to death".

Number of subjects:

Our study will include 200 patients at the Le Vinatier CH Suicide Prevention Center and the Post Crisis Unit at Edouard Herriot Hospital.

inclusion criteria: between the ages of 18 and 25

  • a first suicide attempt
  • Master French sufficient

Exclusion Criteria:

-Majors protected: under curatorship or under guardianship

Course of the study :

-Inclusion will take place immediately after the first suicide attempt at the Post Crisis Unit at Edouard Herriot Hospital and the Suicide Prevention Center.

An anamnestic collection of social and demographic data will be carried out: level of urbanity, professional activity, level of study, access to care, and previous care received, socio-economic level, social and family context (notably existing conflict with parents or love break-up). The patient's telephone number will be collected as well as the patient's psychiatric and addiction history, and the means used for the suicide attempt.

Different scales of assessments, by means of self-questionnaires, will be given to the patient and an investigator will provide the C-SSRS scale assessment for the suicidal risk severity. Finally a venous blood sample will be performed with a measure of total and mature serum BDNF and cortisolemia. Capillary cortisol will also be measured.

After obtaining the patient's consent, two blood samples (DNA and RNA) will be collected and stored at -80 degrees to create a biological collection for later research.

An orientation in the course of care will then be given to the subject who will receive the appropriate care as well as a phone call made by the Suicide Prevention Center.

-At 3 months: A phone call will be made to check the presence or absence of the main evaluation criterion: the repetition of a suicide attempt. In addition, the patient will be asked about life events during these three months and the care received since inclusion.

Benefits and risks of this study:

The expected benefits of this study are: a better understanding of the mechanisms underlying the recurrence of the suicidal act, which could allow an optimal patient management and an adapted orientation in the care network, this for a setting in place in the near future.

In addition, patients included in the study will benefit from follow-up.

The foreseeable risk is the SR that can lead to suicide. To minimize this risk, each patient included in this protocol will benefit from a clinical evaluation performed by a trained investigator. At the end of this evaluation, according to the observed suicidal risk, an orientation in the course of care will be proposed. Each patient will be informed of the different modalities of psychiatry consultations and how to challenge the network. In addition, all patients will receive a phone call from the Suicide Prevention Center.

No serious adverse effects that could be attributed to the project are expected as part of this research.

Indeed, the blood test is carried out systematically as part of a post-suicide treatment and no other invasive examination is scheduled. The only undesirable events that can occur after a venous blood collection are: a hematoma at the point of puncture, pain during the bite, vagal discomfort or rare cases of infectious risks. These risks are greatly minimized by means of sterile single-use equipment and qualified medical personnel, and can not be considered as a serious expected adverse effect.

Conditions
Suicide
Being tested
clinical and biological correlates
Keywords
suicide attempt, suicide re attempt
Medical subject headings
Suicide, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clinical and biological correlatesOther

    To measure the rate of suicidal re attempt (SR) in a population of young adults aged 18 to 25 years.

    To identify sociodemographic, clinical and biological characteristics of a population of suicidal young people, in an attempt to highlight potential risk factors

Study groups in NCT03538197
Study groupRoleWhat they receive
SUICID ATTEMPT YOUNG PEOPLEOtherSuicide Re Attempts in Young Adults after first suicide attempt : socio-demographic, clinical and biological correlates
Receives: Other: clinical and biological correlates

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of the prevalence of SR rate over a 3-months period after the first suicide attempt, among young adults aged 18 to 25.

    Measured: Within the first 3 months following a first suicide attempt

Secondary outcomes (21)
  1. mature and total BDNF

    We will try to highlight correlations between the reiteration of the suicidal act and biological measures

    Measured: Within the first 3 months after the first suicide attempt

  2. level of urbanity

    sociodemographic risk factor

    Measured: Within the first 3 month following a first suicide attempt

  3. socio-economic level

    sociodemographic risk factor

    Measured: Within the first 3 month following a first suicide attempt

  4. social and family context

    sociodemographic risk factor

    Measured: Within the first 3 months following a first suicide attempt

  5. date of birth

    sociodemographic risk factor

    Measured: Within the first 3 months following a first suicide attempt

  6. place of birth

    sociodemographic risk factor

    Measured: Within the first 3 months following a first suicide attempt

  7. BIS : Barratt Impulsive Scale

    The Barratt Impulsiveness Scale (BIS) is a widely used measure of impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  8. C-SSRS : Colombia Suicide Severity Rating Scale

    The Screener contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime and past 3 months. Each question addresses a different component of the respondent's suicide ideation severity and behavior.

    Question 1: wish to be dead Question 2: non-specific suicidal thoughts Questions 3-5: more specific suicidal thoughts and intent to act Question 6: suicidal behavior over the respondent's lifetime and past 3 months If the respondent answers "yes" to Question 2, he/she is instructed to answer Questions 3-5. If the respondent answers "no" to Question 2, he/she may skip to Question 6.

    An answer of "yes" to any of the six questions may indicate a need for referral to a trained mental health professional and an answer of "yes" to questions 4, 5 or 6 indicate high-risk.

    Measured: Within the first 3 months following a first suicide attempt

  9. hair cortisol and blood cortisol

    We will try to highlight correlations between the reiteration of the suicidal act and biological measures

    Measured: Within the first 3 months following a first suicide attempt

  10. Analog visual scales

    The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  11. Negative life events during the last 6 months

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  12. The reasons for living inventory

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  13. CTQ : childhood trauma questionnary

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  14. STAXI-2

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  15. PQB : psychosis risk screening

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  16. QIDS : Quick Inventory of Depressive Symptomatology

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  17. MDQ : Mood disorder questionnaire

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  18. CUDIT : Cannabis use Disorders Identification Test

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  19. CAST : Cannabis Abuse Screening Test

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  20. Fagerstrom Questionary

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

  21. AUDIT : Alcohol use disorders test

    Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales

    Measured: Within the first 3 months following a first suicide attempt

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2018
  2. Study start22 May 2018
  3. Primary completion29 Jun 2022
  4. Study completion29 Jun 2022

Resources

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
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Cohort study
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03538197
Sponsor's protocol ID
2017-A03129-44
Acronym
SURAYA
Status last verified
Sep 2024
First submitted
16 Apr 2018
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Abrial E, Chalancon B, Leaune E, Brunelin J, Wallon M, Moll F, Barakat N, Hoestlandt B, Fourier A, Simon L, Magnin C, Hermand M, Poulet E. Investigating Predictive Factors of Suicidal Re-attempts in Adolescents and Young Adults After a First Suicide Attempt, a Prospective Cohort Study. Study Protocol of the SURAYA Project. Front Psychiatry. 2022 Jun 29;13:916640. doi: 10.3389/fpsyt.2022.916640. eCollection 2022.

    PubMed 35845461

Questions about this trial

What is this clinical trial studying?

A study testing clinical and biological correlates in people with Suicide, run by Hôpital le Vinatier 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the prevalence of SR rate over a 3-months period after the first suicide attempt, among young adults aged 18 to 25. (time frame: Within the first 3 months following a first suicide attempt). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03538197, which also lists 1 linked publication.

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 19 Sep 2024.

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