Clinical trial NCT02829671: Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas
Official title: Study of Loneliness as Predictive Factor for Suicidal Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorders
Keywords: Loneliness
Suicidal behavior
Depression
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

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)

Primary outcomes:
measure: frequency of suicide attempts at one year
timeFrame: At 12 months
Secondary outcomes:
measure: frequency of suicide attempts during the follow up
timeFrame: At 3 and 6 months
measure: comorbid psychiatric disorders of Axis I
timeFrame: At the inclusion, 3, 6, and 12 months
measure: intensity of the depression
timeFrame: At the inclusion, 3, 6, and 12 months
measure: intensity of suicidal ideation
timeFrame: At the inclusion, 3, 6, and 12 months
measure: features of suicidal behavior
timeFrame: At the inclusion, 3, 6, and 12 months
measure: personal history of childhood abuse
timeFrame: At the inclusion, 3, 6, and 12 months
measure: intensity of psychological pain
timeFrame: At the inclusion, 3, 6, and 12 months
measure: inflammatory markers
timeFrame: At the inclusion, 3, 6, and 12 months
measure: thyroid function
timeFrame: At the inclusion
measure: lipid profile
timeFrame: At the inclusion
Other outcomes:
Locations:
Study officials:
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