Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas

Study Overview
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Brief Summary
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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
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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

Official Title
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Study of Loneliness as Predictive Factor for Suicidal Behavior

Conditions
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Major Depressive Disorders

Intervention / Treatment
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* Other: Clinical and biological assessment


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with major depressive disorders<br> | Other: Clinical and biological assessment<br>* Blood sample, clinical assessment with questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of suicide attempts during the follow up | frequency of suicide attempts during the follow up | At 3 and 6 months | 
| comorbid psychiatric disorders of Axis I | comorbid psychiatric disorders of Axis I assessed by the Mini International Neuropsychiatric Interview (MINI) | At the inclusion, 3, 6, and 12 months | 
| 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. | At the inclusion, 3, 6, and 12 months | 
| intensity of suicidal ideation | intensity of suicidal ideation assessed by visual analogic scale | At the inclusion, 3, 6, and 12 months | 
| 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). | At the inclusion, 3, 6, and 12 months | 
| personal history of childhood abuse | personal history of childhood abuse assessed by the Childhood Trauma Questionnaire | At the inclusion, 3, 6, and 12 months | 
| intensity of psychological pain | intensity of psychological pain assessed by visual analogic scale | At the inclusion, 3, 6, and 12 months | 
| inflammatory markers | level of C protein reactive in a blood sample collected at inclusion | At the inclusion, 3, 6, and 12 months | 
| thyroid function | levels of thyroid-stimulating hormone (TSH), triiodothyronine(T3), and thyroxine(T4) in a blood sample collected at inclusion | At the inclusion | 
| lipid profile | level of cholesterol, triglycerides, phospholipids in a blood sample collected at inclusion | At the inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loneliness, Suicidal behavior, Depression