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Predictors of Suicidal Behavior in Depression (SECS)

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ClinicalTrials.gov Identifier: NCT02904005
Recruitment Status : Unknown
Verified July 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : September 16, 2016
Last Update Posted : September 16, 2016
Sponsor:
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
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Suicidal Behavior Depression Traumatic Events Impulsivity Aggression Other: Standardized assessment on depressed patients Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: National Multicentric Study on the Predictive Factors for Suicidal Behavior During a Major Depressive Episode
Study Start Date : March 2015
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Depressed patients
Depressed patients with a recent suicide attempt or without any personal history of suicide attempt
Other: Standardized assessment on depressed patients

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 Measures :
  1. 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 )


Secondary Outcome Measures :
  1. Depressive level [ Time Frame: At 3, 6 and 12 months after the inclusion ]
    Measured by clinician with Inventory of Depressive Symptomotology (IDS-C 30)

  2. Depressive level [ Time Frame: At 3, 6 and 12 months after the inclusion ]
    Measured with a self questionnaire Quick Inventory of Depressive Symptomatology (QIDS-RS)

  3. Anxiety [ Time Frame: At 3, 6 and 12 months after the inclusion ]
    Measured with a self questionnaire the State-Trait Anxiety Inventory (STAI)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904005


Contacts
Contact: Emilie OLIE, MD PhD +33 4 67 33 82 89 e-olie@chu-montpellier.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Contact: GENTY Catherine, MD    +33 4 67 99 61 45 75    c-genty@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
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: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02904005     History of Changes
Other Study ID Numbers: UF 9475
2014-A01316-41 ( Other Identifier: Agence Nationale de sécurité des Médicaments )
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Montpellier:
Suicide
Prediction
Prospective study
Suicide attempt
Risk management

Additional relevant MeSH terms:
Depression
Depressive Disorder
Aggression
Impulsive Behavior
Behavioral Symptoms
Mood Disorders
Mental Disorders