Clinical trial NCT02904005: Predictors of Suicidal Behavior in Depression
Official title: National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicidal Behavior
Depression
Traumatic Events
Impulsivity Aggression
Keywords: Suicide
Prediction
Prospective study
Suicide attempt
Risk management
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: Centre Hospitalier Universiatire La Conception, Marseille
name: Centre Hospitalier Régional et Universitaire de Brest
name: Hôpital Saint Anne, Paris
name: Créteil Hospital
name: Centre Hospitalier Charles Perrens, Bordeaux
name: Centre Hospitalier Universiatire Lyon
name: Centre Hospitalier Universitaire de Nīmes
name: INSERM U1061 Montpellier
name: Centre Hospitalier Universitaire de Besancon
First posted: 2016-09-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: Inclusion criteria:

* \>18 years old
* Diagnostic Statistical Manuel IV (DSM IV) criteria for major depressive episode (
* Subject signs a non-opposition form
* Able to understand the nature, purpose and methodology of the study
* Affiliated with a French social security agency
* Not planning to change residence within 12 months
* Available by phone and / or email

Specific inclusion criteria for the suicide group:

- Admission to the hospital within 48 hours of the last suicide attempt.

Specific inclusion criteria for emotional control group:

- No history of lifetime suicide attempt suicide.

Exclusion criteria:

* Patients hospitalized for more than 7 days
* Refusal to participate
* Individual deprived of freedom (by judicial or administrative decision)
* Individual protected by law (guardianship)
* Subject to exclusion period in another protocol
* Not affiliated to a social security agency

Primary outcomes:
measure: Suicide attempt during follow-up
timeFrame: At one year
Secondary outcomes:
measure: Depressive level
timeFrame: At 3, 6 and 12 months after the inclusion
measure: Depressive level
timeFrame: At 3, 6 and 12 months after the inclusion
measure: Anxiety
timeFrame: At 3, 6 and 12 months after the inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
References: