Suicidal BehaviourNCT02858635
Molecular Genetics of Suicidal Behavior
A study testing Clinical and neuropsychological assessment, Blood and saliva samples in people with Suicidal Behaviour, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Behaviour
- What is being tested?
- Clinical and neuropsychological assessment, Blood and saliva samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,982 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2001to Sep 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- personal history of suicide attempt
- French Caucasian Western Europe and specifically have all four grandparents from a country in Western Europe (for genetics purposes)
- able to understand nature, aims, and methodology oh the study
- do not emphasize to leave during the time-study.
Who cannot join
- Pregnancy
- Not able to speak, read and understand French
- Patient on protective measures (guardianship or trusteeship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Genetics of Suicidal Behavior: Study of Association Between Aggressive Impulsiveness and Genes of the Serotoninergic System
Suicide is a major health problem that causes annually a million death worldwide. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. According to this model, individuals who carry a suicidal act when subjected to stress factors (environmental stress, depression, substance ...) are those which have a specific vulnerability.These vulnerabilities can be considered as clinical parameters (propensity to despair, aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly underpinned by genetic factors. The interest of current researches is to identify biomarkers that will improve the opportunities for early identification of subject with a risk for SB.
The four goals of this project are in the continuity of previous works team:
Read more
- To determine whether combinations of the main serotonin-related genes may better contribute to the vulnerability to SB, than when they are considered independently.
- To assess whether the associations between these genes and SB are modulated by childhood trauma, life events and stress response associated with these environmental factors.
- To test the value of combined clinical, neuropsychological and genetic factor for suicide prevention, in a prospective study, in particularity impulsivity and gene gene interaction.
- To investigate the association between events in real life (using ecological momentary assessment) and emotional response and suicidal ideation.
The investigators propose to use a multidisciplinary approach to answer these questions and, hence, be able to identify new prevention strategies for SB.
Read the detailed description
Transversal study:
1500 patients with a personal history of suicide attempt will be recruited. Clinical, biological and neuropsychological assessments will be performed. The first objective of the study is to replicate the results already obtained regarding the association between serotonergic system genes and suicidal behaviour. The allele frequencies for different markers tested in suicidal and in control subjects with no history of suicidal behaviour will be compared. The patients that will be recruited will be compared to the control population already recruited for another project.
Prospective study: 554 patients hospitalized for a suicide attempt will will be evaluated, each 6 month, during the 2-years period of the study. Clinical, biological and neuropsychological assessments will be performed.
At the end of the inclusion visit, 60 participants will be assessed using ecological momentary assessment(ESM). They will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.
- Conditions
- Suicidal Behaviour
- Being tested
- Clinical and neuropsychological assessment, Blood and saliva samples
- Keywords
- Suicidal behaviour, Impulsivity, Genetics, Serotonin
- Medical subject headings
- Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and neuropsychological assessment, Blood and saliva samplesOther
Clinical and neuropsychological assessment: impulsivity, aggressiveness, psychological pain, angor with specific scales and smartphone.
| Study group | Role | What they receive |
|---|---|---|
| Suicide attempters | Experimental | Clinical and neuropsychological assessment. Blood and saliva samples in order to answer objectives study. Receives: Other: Clinical and neuropsychological assessment, Blood and saliva samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of suicide attempt
occurrence of a suicide attempt will be assessed by the Columbia History Form at each visit
Measured: up to 6 months
Secondary outcomes (8)
suicidal ideation
suicidal ideation will be assessed by scale for suicidal ideation (SSI) self-assessments (with a smartphone) by Likert scales, 5 times per day during 7 days.
Measured: up to 7 days
number of suicide attempt
assessed by clinical interview
Measured: 1 hour
type of suicide attempt
assessed by clinical interview
Measured: 1 hour
lethality of suicide attempt
assessed by Risk-Rescue Rating Scale (RRRS)
Measured: 1 hour
anger
assessed by State-Trait Anger Expression Inventory (STAXI scale)
Measured: 1 hour
Impulsivity
assessed by barratt impulsiveness scale (BIS scale)
Measured: 1 hour
aggressiveness
assessed by buss durkee hostility inventory (BDHI)
Measured: 1 hour
psychological pain
assessed by Likert scale
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startSep 2001
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal BehaviourStudies of the same condition, open and under way.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,982 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Créteil Hospital, Central Hospital, Nancy, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858635
- Sponsor's protocol ID
- 7653
- Status last verified
- Aug 2016
- First submitted
- 18 Jul 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Genetics of Suicidal Behavior: Study of Association Between Aggressive Impulsiveness and Genes of the Serotoninergic System
- ClinicalTrials.gov ID
- NCT02858635
- Acronym / sponsor ID
- 7653
- Conditions
- Suicidal Behaviour
- Keywords
- Suicidal behaviour, Impulsivity, Genetics, Serotonin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,982 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Créteil Hospital, Central Hospital, Nancy, France
- Study start
- Sep 2001
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Aug 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. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. According to this model, individuals who carry a suicidal act when subjected to stress factors (environmental stress, depression, substance ...) are those which have a specific vulnerability.These vulnerabilities can be considered as clinical parameters (propensity to despair, aggressive and/or impulsive traits), neurobiological parameters (dysfunction of the serotonergic system, ...) and cognitive parameters (taking disadvantageous decision ...). Suicidal vulnerability is partly underpinned by genetic factors. The interest of current researches is to identify biomarkers that will improve the opportunities for early identification of subject with a risk for SB.
The four goals of this project are in the continuity of previous works team:
- To determine whether combinations of the main serotonin-related genes may better contribute to the vulnerability to SB, than when they are considered independently.
- To assess whether the associations between these genes and SB are modulated by childhood trauma, life events and stress response associated with these environmental factors.
- To test the value of combined clinical, neuropsychological and genetic factor for suicide prevention, in a prospective study, in particularity impulsivity and gene gene interaction.
- To investigate the association between events in real life (using ecological momentary assessment) and emotional response and suicidal ideation.
The investigators propose to use a multidisciplinary approach to answer these questions and, hence, be able to identify new prevention strategies for SB.
Detailed description
Transversal study:
1500 patients with a personal history of suicide attempt will be recruited. Clinical, biological and neuropsychological assessments will be performed. The first objective of the study is to replicate the results already obtained regarding the association between serotonergic system genes and suicidal behaviour. The allele frequencies for different markers tested in suicidal and in control subjects with no history of suicidal behaviour will be compared. The patients that will be recruited will be compared to the control population already recruited for another project.
Prospective study: 554 patients hospitalized for a suicide attempt will will be evaluated, each 6 month, during the 2-years period of the study. Clinical, biological and neuropsychological assessments will be performed.
At the end of the inclusion visit, 60 participants will be assessed using ecological momentary assessment(ESM). They will be instructed to carry a smartphone with them for one week, and to record at each alarm signal daily life events, negative emotions, psychological pain, suicidal ideas, and specific attributions to these events. Participants will be signalled five times a day during the period. Subjects will be contacted by telephone halfway through the assessment period to monitor and encourage compliance.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suicide attempters | Experimental | Other: Clinical and neuropsychological assessment, Blood and saliva samplesClinical and neuropsychological assessment. Blood and saliva samples in order to answer objectives study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- personal history of suicide attempt
- French Caucasian Western Europe and specifically have all four grandparents from a country in Western Europe (for genetics purposes)
- able to understand nature, aims, and methodology oh the study
- do not emphasize to leave during the time-study.
Key exclusion criteria (3 listed)
- Pregnancy
- Not able to speak, read and understand French
- 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 neuropsychological assessment, Blood and saliva samplesClinical and neuropsychological assessment: impulsivity, aggressiveness, psychological pain, angor with specific scales and smartphone. | Other | Suicide attempters |
Primary outcome
occurrence of suicide attempt
Time frame: up to 6 months
occurrence of a suicide attempt will be assessed by the Columbia History Form at each visit
8 secondary outcomes
suicidal ideation
Time frame: up to 7 days
number of suicide attempt
Time frame: 1 hour
type of suicide attempt
Time frame: 1 hour
lethality of suicide attempt
Time frame: 1 hour
anger
Time frame: 1 hour
Impulsivity
Time frame: 1 hour
aggressiveness
Time frame: 1 hour
psychological pain
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and neuropsychological assessment, Blood and saliva samples in people with Suicidal Behaviour, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
occurrence of suicide attempt (time frame: up to 6 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 8 Aug 2016.