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

Suicide Clinical Trial

— SURAYA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03538197
• Other study ID #: 2017-A03129-44
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2018
• Est. completion date: January 30, 2023

Study information

• Verified date: March 2022
• Source: Hôpital le Vinatier
• Contact: POULET Emmanuel, Ph
• Phone: 04 72 11 00 09
• Email: emmanuel.poulet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

Other:
• clinical and biological correlates
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

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron	Aura

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the prevalence of SR rate over a 3-months period after the first suicide attempt, among young adults aged 18 to 25.		Within the first 3 months following a first suicide attempt
Secondary	mature and total BDNF	We will try to highlight correlations between the reiteration of the suicidal act and biological measures	Within the first 3 months after the first suicide attempt
Secondary	level of urbanity	sociodemographic risk factor	Within the first 3 month following a first suicide attempt
Secondary	socio-economic level	sociodemographic risk factor	Within the first 3 month following a first suicide attempt
Secondary	social and family context	sociodemographic risk factor	Within the first 3 months following a first suicide attempt
Secondary	date of birth	sociodemographic risk factor	Within the first 3 months following a first suicide attempt
Secondary	place of birth	sociodemographic risk factor	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	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.	Within the first 3 months following a first suicide attempt
Secondary	hair cortisol and blood cortisol	We will try to highlight correlations between the reiteration of the suicidal act and biological measures	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	STAXI-2	Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt
Secondary	Fagerstrom Questionary	Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales	Within the first 3 months following a first suicide attempt
Secondary	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	Within the first 3 months following a first suicide attempt