Predictors of Suicidal Behavior in Depression (SECS)

University Hospital Center (CHU)

Status: Unknown

Conditions: Suicidal Behavior; Impulsivity Aggression; Depression; Traumatic Events

Treatments: Other: Standardized assessment on depressed patients

Study type: Interventional

Funder types: Other

Identifiers

NCT02904005

2014-A01316-41 (Other Identifier)

UF 9475

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Depressed patients

Other group

Description:

Depressed patients with a recent suicide attempt or without any personal history of suicide attempt

Treatment:

Other: Standardized assessment on depressed patients