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Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas (SOLSTIS)

Primary Purpose

Major Depressive Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical and biological assessment
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Major Depressive Disorders focused on measuring Loneliness, Suicidal behavior, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Main diagnosis of major depressive disorder according to Diagnostic and Statistical Manual of Mental DisordersIV (DSM IV) Having signed informed consent Able to understand nature, aims, and methodology oh the study

Exclusion criteria:

Participation in another clinical trial Patient on protective measures (guardianship or trusteeship)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Patients with major depressive disorders

    Arm Description

    Outcomes

    Primary Outcome Measures

    frequency of suicide attempts at one year
    frequency of suicide attempts during the 12 months follow-up depending on the intensity of the feeling of loneliness evaluated by the loneliness scale of the University of Laval (ESUL)

    Secondary Outcome Measures

    frequency of suicide attempts during the follow up
    frequency of suicide attempts during the follow up
    comorbid psychiatric disorders of Axis I
    comorbid psychiatric disorders of Axis I assessed by the Mini International Neuropsychiatric Interview (MINI)
    intensity of the depression
    intensity of the depression assessed by the physician with the Inventory of Depressive Symptomatology, clinician rating (IDSC-30) and with the Montgomery-Asberg depression rating scale (MADRS) and assessed by the patient with the Beck Depression Inventory (BDI) scale.
    intensity of suicidal ideation
    intensity of suicidal ideation assessed by visual analogic scale
    features of suicidal behavior
    Features of SB (number and methods of suicide attempts, nature of the precipitating factor, motivation, lethality, level of impulsiveness or premeditation) by the Columbia-Suicide Severity Rating Scale (CSSRS), the Risk Rescue Rating Scale (RRRS) and the Suicidal Intent Scales (SIS).
    personal history of childhood abuse
    personal history of childhood abuse assessed by the Childhood Trauma Questionnaire
    intensity of psychological pain
    intensity of psychological pain assessed by visual analogic scale
    inflammatory markers
    level of C protein reactive in a blood sample collected at inclusion
    thyroid function
    levels of thyroid-stimulating hormone (TSH), triiodothyronine(T3), and thyroxine(T4) in a blood sample collected at inclusion
    lipid profile
    level of cholesterol, triglycerides, phospholipids in a blood sample collected at inclusion

    Full Information

    First Posted
    July 7, 2016
    Last Updated
    December 21, 2021
    Sponsor
    University Hospital, Montpellier
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02829671
    Brief Title
    Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas
    Acronym
    SOLSTIS
    Official Title
    Study of Loneliness as Predictive Factor for Suicidal Behavior
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    October 11, 2016 (Actual)
    Primary Completion Date
    June 24, 2020 (Actual)
    Study Completion Date
    June 24, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Montpellier

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Suicide is a major health problem that causes annually a million death worldwide. Loneliness is known to be associated with suicidal ideation in minors and to be related with suicidal risk in elderly people. However little is known about this association in a middle-aged population. Loneliness is a modifiable factor with suitable psychotherapeutic measures, it is essential to improve the scientific and medical knowledge about the link between this feeling and suicide risk in a population of depressed patients in middle age. The main objective is the study of the relationship between loneliness and the occurrence of suicidal behavior (SB) in major depressed adult population over 12 months. The secondary objectives are: Identification of risk factors (clinical, neuropsychological and biological) of the occurrence of SB within a clinical population and their interaction; Identification of predictive factors (clinical, neuropsychological, biological) therapeutic response to antidepressant in the context of depression.
    Detailed Description
    This project is based on clinical, neuropsychological and biological data routinely collected in the Department of Emergency Psychiatry and Post Acute Care. This is a one year follow-up prospective study. Over three years, 600 depressed patients will be recruited. First visit (inclusion): clinical, biological and neuropsychological assessment Follow up visits (3, 6 and 12 months): clinical assessment only

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorders
    Keywords
    Loneliness, Suicidal behavior, Depression

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with major depressive disorders
    Arm Type
    Other
    Intervention Type
    Other
    Intervention Name(s)
    Clinical and biological assessment
    Intervention Description
    Blood sample, clinical assessment with questionnaires
    Primary Outcome Measure Information:
    Title
    frequency of suicide attempts at one year
    Description
    frequency of suicide attempts during the 12 months follow-up depending on the intensity of the feeling of loneliness evaluated by the loneliness scale of the University of Laval (ESUL)
    Time Frame
    At 12 months
    Secondary Outcome Measure Information:
    Title
    frequency of suicide attempts during the follow up
    Description
    frequency of suicide attempts during the follow up
    Time Frame
    At 3 and 6 months
    Title
    comorbid psychiatric disorders of Axis I
    Description
    comorbid psychiatric disorders of Axis I assessed by the Mini International Neuropsychiatric Interview (MINI)
    Time Frame
    At the inclusion, 3, 6, and 12 months
    Title
    intensity of the depression
    Description
    intensity of the depression assessed by the physician with the Inventory of Depressive Symptomatology, clinician rating (IDSC-30) and with the Montgomery-Asberg depression rating scale (MADRS) and assessed by the patient with the Beck Depression Inventory (BDI) scale.
    Time Frame
    At the inclusion, 3, 6, and 12 months
    Title
    intensity of suicidal ideation
    Description
    intensity of suicidal ideation assessed by visual analogic scale
    Time Frame
    At the inclusion, 3, 6, and 12 months
    Title
    features of suicidal behavior
    Description
    Features of SB (number and methods of suicide attempts, nature of the precipitating factor, motivation, lethality, level of impulsiveness or premeditation) by the Columbia-Suicide Severity Rating Scale (CSSRS), the Risk Rescue Rating Scale (RRRS) and the Suicidal Intent Scales (SIS).
    Time Frame
    At the inclusion, 3, 6, and 12 months
    Title
    personal history of childhood abuse
    Description
    personal history of childhood abuse assessed by the Childhood Trauma Questionnaire
    Time Frame
    At the inclusion, 3, 6, and 12 months
    Title
    intensity of psychological pain
    Description
    intensity of psychological pain assessed by visual analogic scale
    Time Frame
    At the inclusion, 3, 6, and 12 months
    Title
    inflammatory markers
    Description
    level of C protein reactive in a blood sample collected at inclusion
    Time Frame
    At the inclusion, 3, 6, and 12 months
    Title
    thyroid function
    Description
    levels of thyroid-stimulating hormone (TSH), triiodothyronine(T3), and thyroxine(T4) in a blood sample collected at inclusion
    Time Frame
    At the inclusion
    Title
    lipid profile
    Description
    level of cholesterol, triglycerides, phospholipids in a blood sample collected at inclusion
    Time Frame
    At the inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Main diagnosis of major depressive disorder according to Diagnostic and Statistical Manual of Mental DisordersIV (DSM IV) Having signed informed consent Able to understand nature, aims, and methodology oh the study Exclusion criteria: Participation in another clinical trial Patient on protective measures (guardianship or trusteeship)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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