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Completed

NCT Number: NCT02829671

Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas

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.

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Key information

Conditions

Major Depressive Disorders Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clinical and biological assessment

Other

Blood sample, clinical assessment with questionnaires

Primary outcomes

  1. frequency of suicide attempts at one year

    Time frame: 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 outcomes

  1. frequency of suicide attempts during the follow up

    Time frame: At 3 and 6 months

    frequency of suicide attempts during the follow up

  2. comorbid psychiatric disorders of Axis I

    Time frame: At the inclusion, 3, 6, and 12 months

    comorbid psychiatric disorders of Axis I assessed by the Mini International Neuropsychiatric Interview (MINI)

  3. intensity of the depression

    Time frame: 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.

  4. intensity of suicidal ideation

    Time frame: At the inclusion, 3, 6, and 12 months

    intensity of suicidal ideation assessed by visual analogic scale

  5. features of suicidal behavior

    Time frame: 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).

  6. personal history of childhood abuse

    Time frame: At the inclusion, 3, 6, and 12 months

    personal history of childhood abuse assessed by the Childhood Trauma Questionnaire

  7. intensity of psychological pain

    Time frame: At the inclusion, 3, 6, and 12 months

    intensity of psychological pain assessed by visual analogic scale

  8. inflammatory markers

    Time frame: At the inclusion, 3, 6, and 12 months

    level of C protein reactive in a blood sample collected at inclusion

  9. thyroid function

    Time frame: At the inclusion

    levels of thyroid-stimulating hormone (TSH), triiodothyronine(T3), and thyroxine(T4) in a blood sample collected at inclusion

  10. lipid profile

    Time frame: At the inclusion

    level of cholesterol, triglycerides, phospholipids in a blood sample collected at inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Study of Loneliness as Predictive Factor for Suicidal Behavior

Acronym: SOLSTIS

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 12, 2016
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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