Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas

NCT02829671 | Completed

• 2 other identifiers: UF 97022016- -A00276-45
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorders

Keywords

Loneliness; Suicidal behavior; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• frequency of suicide attempts during the follow up

  At 3 and 6 months

• comorbid psychiatric disorders of Axis I

  At the inclusion, 3, 6, and 12 months

• intensity of the depression

  At the inclusion, 3, 6, and 12 months

• intensity of suicidal ideation

  At the inclusion, 3, 6, and 12 months

• features of suicidal behavior

  At the inclusion, 3, 6, and 12 months

Study Arms (1)

Patients with major depressive disorders

OTHER

Other: Clinical and biological assessment

Interventions

Clinical and biological assessment OTHER

Blood sample, clinical assessment with questionnaires

Patients with major depressive disorders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 12, 2016
• Study Start: October 11, 2016
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share