Suicidal BehaviorSECSNCT02904005
Predictors of Suicidal Behavior in Depression
A study testing Standardized assessment on depressed patients in people with Suicidal Behavior and Depression, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Behavior, Depression, Traumatic Events
- What is being tested?
- Standardized assessment on depressed patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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
Show all 11Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, 34295
GENTY Catherine, MD, +33 4 67 99 61 45 75, c-genty@chu-montpellier.fr
About this study
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.
Read the 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:
- 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:
- 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:
- 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.
- Being tested
- Standardized assessment on depressed patients
- Keywords
- Suicide, Prediction, Prospective study, Suicide attempt, Risk management
- Medical subject headings
- Depression, Suicide, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized assessment on depressed patientsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Depressed patients | Other | Depressed patients with a recent suicide attempt or without any personal history of suicide attempt Receives: Other: Standardized assessment on depressed patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide attempt during follow-up
Evaluation of the occurrence of a suicide attempt by the Columbia-Suicide Severity Rating Scale (C-SSRS )
Measured: At one year
Secondary outcomes (3)
Depressive level
Measured by clinician with Inventory of Depressive Symptomotology (IDS-C 30)
Measured: At 3, 6 and 12 months after the inclusion
Depressive level
Measured with a self questionnaire Quick Inventory of Depressive Symptomatology (QIDS-RS)
Measured: At 3, 6 and 12 months after the inclusion
Anxiety
Measured with a self questionnaire the State-Trait Anxiety Inventory (STAI)
Measured: At 3, 6 and 12 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904005
- Sponsor's protocol ID
- UF 9475
- Other IDs
- 2014-A01316-41
- Acronym
- SECS
- Status last verified
- Jul 2016
- First submitted
- 19 Jul 2016
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode
- ClinicalTrials.gov ID
- NCT02904005
- Acronym / sponsor ID
- SECS / UF 9475
- Keywords
- Suicide, Prediction, Prospective study, Suicide attempt, Risk management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- 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
- Study start
- Mar 2015
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Depressed patients | Other | Other: Standardized assessment on depressed patientsDepressed patients with a recent suicide attempt or without any personal history of suicide attempt |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- >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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized assessment on depressed patientsAt 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). | Other | Depressed patients |
Primary outcome
Suicide attempt during follow-up
Time frame: At one year
Evaluation of the occurrence of a suicide attempt by the Columbia-Suicide Severity Rating Scale (C-SSRS )
3 secondary outcomes
Depressive level
Time frame: At 3, 6 and 12 months after the inclusion
Depressive level
Time frame: At 3, 6 and 12 months after the inclusion
Anxiety
Time frame: At 3, 6 and 12 months after the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized assessment on depressed patients in people with Suicidal Behavior and Depression, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emilie OLIE, MD PhD (+33 4 67 33 82 89, e-olie@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide attempt during follow-up (time frame: At one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.