Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas

Major Depressive Disorders Clinical Trial

— SOLSTIS  

Official title:

Study of Loneliness as Predictive Factor for Suicidal Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829671
• Other study ID #: UF 9702
• Secondary ID: 2016- -A00276-45
• Status: Completed
• Phase: N/A
• Start date: October 11, 2016
• Est. completion date: June 24, 2020

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorders

Intervention

Other:
• Clinical and biological assessment
Blood sample, clinical assessment with questionnaires

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	frequency of suicide attempts during the follow up	frequency of suicide attempts during the follow up	At 3 and 6 months
Secondary	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
Secondary	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
Secondary	intensity of suicidal ideation	intensity of suicidal ideation assessed by visual analogic scale	At the inclusion, 3, 6, and 12 months
Secondary	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
Secondary	personal history of childhood abuse	personal history of childhood abuse assessed by the Childhood Trauma Questionnaire	At the inclusion, 3, 6, and 12 months
Secondary	intensity of psychological pain	intensity of psychological pain assessed by visual analogic scale	At the inclusion, 3, 6, and 12 months
Secondary	inflammatory markers	level of C protein reactive in a blood sample collected at inclusion	At the inclusion, 3, 6, and 12 months
Secondary	thyroid function	levels of thyroid-stimulating hormone (TSH), triiodothyronine(T3), and thyroxine(T4) in a blood sample collected at inclusion	At the inclusion
Secondary	lipid profile	level of cholesterol, triglycerides, phospholipids in a blood sample collected at inclusion	At the inclusion