Major Depressive DisordersSOLSTISNCT02829671
Loneliness and Occurrence of Suicide Attempts and Suicidal Ideas
A study testing Clinical and biological assessment in people with Major Depressive Disorders, run by University Hospital, Montpellier.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorders
- What is being tested?
- Clinical and biological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 11 Oct 2016to 24 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participation in another clinical trial Patient on protective measures (guardianship or trusteeship)
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Major Depressive Disorders
- Being tested
- Clinical and biological assessment
- Keywords
- Loneliness, Suicidal behavior, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and biological assessmentOther
Blood sample, clinical assessment with questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Patients with major depressive disorders | Other | Not described Receives: Other: Clinical and biological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 12 months
Secondary outcomes (10)
frequency of suicide attempts during the follow up
frequency of suicide attempts during the follow up
Measured: 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)
Measured: 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.
Measured: At the inclusion, 3, 6, and 12 months
intensity of suicidal ideation
intensity of suicidal ideation assessed by visual analogic scale
Measured: 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).
Measured: At the inclusion, 3, 6, and 12 months
personal history of childhood abuse
personal history of childhood abuse assessed by the Childhood Trauma Questionnaire
Measured: At the inclusion, 3, 6, and 12 months
intensity of psychological pain
intensity of psychological pain assessed by visual analogic scale
Measured: At the inclusion, 3, 6, and 12 months
inflammatory markers
level of C protein reactive in a blood sample collected at inclusion
Measured: 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
Measured: At the inclusion
lipid profile
level of cholesterol, triglycerides, phospholipids in a blood sample collected at inclusion
Measured: At the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start11 Oct 2016
- Primary completion24 Jun 2020
- Study completion24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829671
- Sponsor's protocol ID
- UF 9702
- Other IDs
- 2016- -A00276-45
- Acronym
- SOLSTIS
- Status last verified
- Dec 2021
- First submitted
- 7 Jul 2016
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Loneliness as Predictive Factor for Suicidal Behavior
- ClinicalTrials.gov ID
- NCT02829671
- Acronym / sponsor ID
- SOLSTIS / UF 9702
- Conditions
- Major Depressive Disorders
- Keywords
- Loneliness, Suicidal behavior, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 11 Oct 2016 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 24 Jun 2020 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with major depressive disorders | Other | Other: Clinical and biological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in another clinical trial Patient on protective measures (guardianship or trusteeship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and biological assessmentBlood sample, clinical assessment with questionnaires | Other | Patients with major depressive disorders |
Primary outcome
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)
10 secondary outcomes
frequency of suicide attempts during the follow up
Time frame: At 3 and 6 months
comorbid psychiatric disorders of Axis I
Time frame: At the inclusion, 3, 6, and 12 months
intensity of the depression
Time frame: At the inclusion, 3, 6, and 12 months
intensity of suicidal ideation
Time frame: At the inclusion, 3, 6, and 12 months
features of suicidal behavior
Time frame: At the inclusion, 3, 6, and 12 months
personal history of childhood abuse
Time frame: At the inclusion, 3, 6, and 12 months
intensity of psychological pain
Time frame: At the inclusion, 3, 6, and 12 months
inflammatory markers
Time frame: At the inclusion, 3, 6, and 12 months
thyroid function
Time frame: At the inclusion
lipid profile
Time frame: At the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and biological assessment in people with Major Depressive Disorders, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of suicide attempts at one year (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.