Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas (SOLSTIS)

Study of Loneliness as Predictive Factor for Suicidal Behavior

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorders
• Intervention / Treatment: Other: Clinical and biological assessment

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 Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with major depressive disorders	Other: Clinical and biological assessment; Blood sample, clinical assessment with questionnaires

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Actual): June 24, 2020
• Study Completion (Actual): June 24, 2020

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Loneliness; Suicidal behavior
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: UF 9702; 2016- -A00276-45 (Other Identifier: FRANCE: Agence Nationale de Sécurité des Médicaments)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No