Predictors of Suicidal Behavior in Depression (SECS)
Primary Purpose
Suicidal Behavior, Depression, Traumatic Events
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Standardized assessment on depressed patients
Sponsored by
About this trial
This is an interventional screening trial for Suicidal Behavior focused on measuring Suicide, Prediction, Prospective study, Suicide attempt, Risk management
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
Sites / Locations
- Montpellier University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Depressed patients
Arm Description
Depressed patients with a recent suicide attempt or without any personal history of suicide attempt
Outcomes
Primary Outcome Measures
Suicide attempt during follow-up
Evaluation of the occurrence of a suicide attempt by the Columbia-Suicide Severity Rating Scale (C-SSRS )
Secondary Outcome Measures
Depressive level
Measured by clinician with Inventory of Depressive Symptomotology (IDS-C 30)
Depressive level
Measured with a self questionnaire Quick Inventory of Depressive Symptomatology (QIDS-RS)
Anxiety
Measured with a self questionnaire the State-Trait Anxiety Inventory (STAI)
Full Information
NCT ID
NCT02904005
First Posted
July 19, 2016
Last Updated
September 13, 2016
Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Lille, Centre Hospitalier Universiatire La Conception, Marseille, Centre Hospitalier Régional et Universitaire de Brest, Hôpital Saint Anne, Paris, Créteil Hospital, Centre Hospitalier Charles Perrens, Bordeaux, Centre Hospitalier Universiatire Lyon, Centre Hospitalier Universitaire de Nīmes, INSERM U1061 Montpellier, Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT02904005
Brief Title
Predictors of Suicidal Behavior in Depression
Acronym
SECS
Official Title
National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Lille, Centre Hospitalier Universiatire La Conception, Marseille, Centre Hospitalier Régional et Universitaire de Brest, Hôpital Saint Anne, Paris, Créteil Hospital, Centre Hospitalier Charles Perrens, Bordeaux, Centre Hospitalier Universiatire Lyon, Centre Hospitalier Universitaire de Nīmes, INSERM U1061 Montpellier, Centre Hospitalier Universitaire de Besancon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Behavior, Depression, Traumatic Events, Impulsivity Aggression
Keywords
Suicide, Prediction, Prospective study, Suicide attempt, Risk management
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Depressed patients
Arm Type
Other
Arm Description
Depressed patients with a recent suicide attempt or without any personal history of suicide attempt
Intervention Type
Other
Intervention Name(s)
Standardized assessment on depressed patients
Intervention Description
At inclusion, socio-demographic characteristics, main life events, psychopathology (comorbidity, personality dimensions, characterisation of SB) and biological sample will be performed by psychiatrist and nurse. Investigators will retrieve the results of biological assays routinely made as part of standard collect biological results routinely done for all depressed patient.
At follow-up (3 months, 6 months, 12 months), they will assess thymic state, occurrence of suicidal ideation and suicide attempt and environmental stressors. In case of non response, the general physician or the psychiatrist in charge of the patient will be contacted to assess the occurrence of SB during the year. In case of death or absence of clinical information, a request for cause of death certificate will be carried out through tne National Institute of Health and Medical research (INSERM) Unit 1018 / Epidemiological center on medical causes of death (CépiDc).
Primary Outcome Measure Information:
Title
Suicide attempt during follow-up
Description
Evaluation of the occurrence of a suicide attempt by the Columbia-Suicide Severity Rating Scale (C-SSRS )
Time Frame
At one year
Secondary Outcome Measure Information:
Title
Depressive level
Description
Measured by clinician with Inventory of Depressive Symptomotology (IDS-C 30)
Time Frame
At 3, 6 and 12 months after the inclusion
Title
Depressive level
Description
Measured with a self questionnaire Quick Inventory of Depressive Symptomatology (QIDS-RS)
Time Frame
At 3, 6 and 12 months after the inclusion
Title
Anxiety
Description
Measured with a self questionnaire the State-Trait Anxiety Inventory (STAI)
Time Frame
At 3, 6 and 12 months after the inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie OLIE, MD PhD
Phone
+33 4 67 33 82 89
Email
e-olie@chu-montpellier.fr
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENTY Catherine, MD
Phone
+33 4 67 99 61 45 75
Email
c-genty@chu-montpellier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Predictors of Suicidal Behavior in Depression
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