Depression Clinical Trial
Official title:
National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
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