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Trial record 3 of 4 for:    Not yet recruiting Studies | Loneliness

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

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ClinicalTrials.gov Identifier: NCT02829671
Recruitment Status : Not yet recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:

Suicide is a major health problem that causes annually a million death worldwild. Loneliness is known to be associated with suicidal ideation in minors and to be related with suicidal risk in elerly 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 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorders Other: Clinical and biological assessment Not Applicable

Detailed Description:

This project is based on clinical, neuropsychological and biological datas 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  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Study of Loneliness as Predictive Factor for Suicidal Behavior
Study Start Date : July 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Patients with major depressive disorders Other: Clinical and biological assessment
Blood sample, clinical assessment with quetsionnaires




Primary Outcome Measures :
  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 ESUL Scale (loneliness scale of the University of Laval)


Secondary Outcome Measures :
  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 (Mini International Neuropsychiatric Interview)

  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-Åsberg 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. thyroïd 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Main diagnosis of major depressive disorder according to DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders) 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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829671


Contacts
Contact: Philippe Courtet, MD PhD 33 4 67 33 85 81 p-courtet@chu-montpelllier.fr

Sponsors and Collaborators
University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02829671     History of Changes
Other Study ID Numbers: UF 9702
2016- -A00276-45 ( Other Identifier: FRANCE: Agence Nationale de Sécurité des Médicaments )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Montpellier:
Loneliness
Suicidal behavior
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms