Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-23 @ 7:19 AM
Study NCT ID:
NCT02904005
Status:
UNKNOWN
Last Update Posted:
2016-09-16
First Post:
2016-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Suicidal Behavior in Depression
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SECS
Brief Summary:
This study aims at identifying predictors of suicidal behaviors in depressed subjects. Investigators will first compare demographic, clinical, and biological features of depressed recent suicide attempters (within one week) and depressed subjects without lifetime history of suicide attempt. Baseline risk factors for suicide will be used to predict the risk of attempting suicide during a one year follow-up. A thorough evaluation of these patients will allow to identify the factors associated with suicidal risk and develop a simplified risk score that could be used in clinical settings to improve our practice.
Detailed Description:
Background and rationale:
Suicidal behavior (SB) is a major health problem in France, with more than 10,000 suicides (6th UE28) and 220 000 suicide attempts (SA) per year. A large percentage of men (6%) and women (9%) in France have made at least one SA. Moreover, suicide is the second leading cause of death among the youngest (15-44 years). The clinical model currently admitted for understanding SB is a stress vulnerability model. But to date, scientists have not (yet) a clinical application for the research on SB. The management of psychiatric patients, including depressed subjects, faces the impossibility of detecting those at high risk of occurrence of SB. Indeed, although many risk factors for SB are known, their predictive value is very low. In addition, these risk factors are primarily derived from cross-sectional studies. The identification of predictors, using a standardized evaluation would allow clinicians to identify the subject at high risk of SB for which therapeutic interventions and the organization of care should be particularly aggressive and intensive.
Objectives:
Main objective: To identify predictors (clinical, biological, environmental) of the occurrence of SB during 12 months in a population of depressed suicide attempters and lifetime non attempters to optimize a short standardized evaluation applicable to emergency settings.
Secondary objectives: 1) To build a multidimensional score for predicting the risk of recurrence of suicide attempt among suicide attempters ; 2) To evaluate the prospective performance of this score to predict emergence of suicide attempt among depressed patients without history of suicide attempt; 3) To identify predictors of suicidal spectrum (suicidal thoughts, suicidal planification, suicide attempt and completed suicide) in depressed subjects ; 4) To evaluate the feasibility of a multicenter network that will use standardized assessments to evaluate suicidal risk through a secured website.
Methods:
2000 patients with major depressive episode will be recruited in the emergency departments and post-acute care units of 14 French hospitals, and then will be followed for 12 months. For every depressed patient admitted within 48 hours of a suicide attempt (case), a depressed patient without lifetime personal history of SB (psychiatric control) will be included. Cases will be mainly recruited in emergency settings; psychiatric controls will be mainly recruited from the inpatient units (hospital stay \<7 days) and outpatient units to limit selection bias.
At inclusion, at 3, 6 and 12 months, clinical and biological assessments will ne realized.
Statistical analyses:
1\) Kaplan-Meier and Cox models adjusted for potential confounding factors, 2) Univariate and multivariate analysis, 3) Establishment of a predictive score from multivariate analyses.
Short-term perspectives:
1\) Optimization of standardized assessment of suicidal risk in depressed patients applicable in daily practice, and 2) Development of a network of clinical centers involved in suicidology field to promote specific care and research.
Long-term perspectives:
1\) Access to a computerized assessment tool via the Internet to improve the management of depressed patients all over France 2) Understanding of the psychological and biological factors underlying SB in the context of mood disorders, and 3) Development of preventive and therapeutic approaches.
Suicidal behavior (SB) is a major health problem in France, with more than 10,000 suicides (6th UE28) and 220 000 suicide attempts (SA) per year. A large percentage of men (6%) and women (9%) in France have made at least one SA. Moreover, suicide is the second leading cause of death among the youngest (15-44 years). The clinical model currently admitted for understanding SB is a stress vulnerability model. But to date, scientists have not (yet) a clinical application for the research on SB. The management of psychiatric patients, including depressed subjects, faces the impossibility of detecting those at high risk of occurrence of SB. Indeed, although many risk factors for SB are known, their predictive value is very low. In addition, these risk factors are primarily derived from cross-sectional studies. The identification of predictors, using a standardized evaluation would allow clinicians to identify the subject at high risk of SB for which therapeutic interventions and the organization of care should be particularly aggressive and intensive.
Objectives:
Main objective: To identify predictors (clinical, biological, environmental) of the occurrence of SB during 12 months in a population of depressed suicide attempters and lifetime non attempters to optimize a short standardized evaluation applicable to emergency settings.
Secondary objectives: 1) To build a multidimensional score for predicting the risk of recurrence of suicide attempt among suicide attempters ; 2) To evaluate the prospective performance of this score to predict emergence of suicide attempt among depressed patients without history of suicide attempt; 3) To identify predictors of suicidal spectrum (suicidal thoughts, suicidal planification, suicide attempt and completed suicide) in depressed subjects ; 4) To evaluate the feasibility of a multicenter network that will use standardized assessments to evaluate suicidal risk through a secured website.
Methods:
2000 patients with major depressive episode will be recruited in the emergency departments and post-acute care units of 14 French hospitals, and then will be followed for 12 months. For every depressed patient admitted within 48 hours of a suicide attempt (case), a depressed patient without lifetime personal history of SB (psychiatric control) will be included. Cases will be mainly recruited in emergency settings; psychiatric controls will be mainly recruited from the inpatient units (hospital stay \<7 days) and outpatient units to limit selection bias.
At inclusion, at 3, 6 and 12 months, clinical and biological assessments will ne realized.
Statistical analyses:
1\) Kaplan-Meier and Cox models adjusted for potential confounding factors, 2) Univariate and multivariate analysis, 3) Establishment of a predictive score from multivariate analyses.
Short-term perspectives:
1\) Optimization of standardized assessment of suicidal risk in depressed patients applicable in daily practice, and 2) Development of a network of clinical centers involved in suicidology field to promote specific care and research.
Long-term perspectives:
1\) Access to a computerized assessment tool via the Internet to improve the management of depressed patients all over France 2) Understanding of the psychological and biological factors underlying SB in the context of mood disorders, and 3) Development of preventive and therapeutic approaches.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-A01316-41 | OTHER | Agence Nationale de sécurité des Médicaments | View |