Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas

Not Applicable

Completed

• Conditions: Major Depressive Disorders
• Interventions: Other: Clinical and biological assessment

• Registration Number: NCT02829671
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Study Start: 2016-10-11
• Primary Completion: 2020-06-24
• Study Completion: 2020-06-24
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with major depressive disorders	Clinical and biological assessment	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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).
personal history of childhood abuse	At the inclusion, 3, 6, and 12 months	personal history of childhood abuse assessed by the Childhood Trauma Questionnaire
lipid profile	At the inclusion	level of cholesterol, triglycerides, phospholipids in a blood sample collected at inclusion
intensity of psychological pain	At the inclusion, 3, 6, and 12 months	intensity of psychological pain assessed by visual analogic scale
thyroid function	At the inclusion	levels of thyroid-stimulating hormone (TSH), triiodothyronine(T3), and thyroxine(T4) in a blood sample collected at inclusion
inflammatory markers	At the inclusion, 3, 6, and 12 months	level of C protein reactive in a blood sample collected at inclusion