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
About this trial
This is an interventional other trial for Major Depressive Disorders focused on measuring Loneliness, Suicidal behavior, Depression
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)
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
NCT ID
NCT02829671
First Posted
July 7, 2016
Last Updated
December 21, 2021
Sponsor
University Hospital, Montpellier
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
Learn more about this trial
Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas
We'll reach out to this number within 24 hrs