Major Depressive Disorders
Conditions
Keywords
Loneliness, Suicidal behavior, Depression
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
Interventions
OTHERClinical and biological assessment
Blood sample, clinical assessment with questionnaires
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| frequency of suicide attempts at one year | At 12 months | 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
| Measure | Time frame | Description |
|---|---|---|
| frequency of suicide attempts during the follow up | At 3 and 6 months | frequency of suicide attempts during the follow up |
| comorbid psychiatric disorders of Axis I | At the inclusion, 3, 6, and 12 months | comorbid psychiatric disorders of Axis I assessed by the Mini International Neuropsychiatric Interview (MINI) |
| intensity of the depression | At the inclusion, 3, 6, and 12 months | 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 | At the inclusion, 3, 6, and 12 months | intensity of suicidal ideation assessed by visual analogic scale |
| lipid profile | At the inclusion | level of cholesterol, triglycerides, phospholipids in a blood sample collected at inclusion |
| personal history of childhood abuse | At the inclusion, 3, 6, and 12 months | personal history of childhood abuse assessed by the Childhood Trauma Questionnaire |
| intensity of psychological pain | At the inclusion, 3, 6, and 12 months | intensity of psychological pain assessed by visual analogic scale |
| inflammatory markers | At the inclusion, 3, 6, and 12 months | level of C protein reactive in a blood sample collected at inclusion |
| thyroid function | At the inclusion | levels of thyroid-stimulating hormone (TSH), triiodothyronine(T3), and thyroxine(T4) in a blood sample collected at inclusion |
| features of suicidal behavior | At the inclusion, 3, 6, and 12 months | 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). |
Outcome results
None listed