Suicide, AttemptedNCT01493323
Functional Imaging of Psychic Pain
A study testing Assessment of personality traits, Assessment of suicidal act and Assessment of depression in people with Suicide, Attempted and Mood Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Suicidal behaviour (SB) represents a major public health problem, costing life in more that one million people every year worldwide. Even if SB is considered as a consequence of social adversity and depression, these stress factors are often necessary but not sufficient to explain the occurrence of a suicidal act. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Suicide, Attempted, Mood Disorder
- What is being tested?
- Assessment of personality traits, Assessment of suicidal act and Assessment of depression
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Dec 2014
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Non specific criteria, for all the participants:
- Woman- 18-50 years old
- Non menopausal
- Right-handed
- Caucasian from western Europe (exception of Basque and Sardinian), for genetic purposes
- Subject who signed informed consent
- Able to understand the nature, the aim, and the methodology of the study and agree to cooperate during clinical and radiological evaluation
Specific criteria:For depressed suicide attempters :
- DSM IV criteria for major depressive disorder
- Personal history of suicide attempt
- No psychotropic treatment currently
For depressed affective controls :
- DSM IV criteria for major depressive disorder
- No personal history of suicide attempt
- No psychotropic treatment currently
For non depressed suicide attempters :
- Personal history of unipolar or bipolar mood disorder, according to DSM IV criteria
- Normothymic currently (HAMD<7)
- Personal history of suicide attempt
- Minimum treatment Healthy controls :
- No personal history of axis I psychiatric disorders according to the MINI and the DSM IV criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuro Anatomic Basis of Psychic Pain in Depression and Suicidal Behaviour
Suicidal behaviour (SB) represents a major public health problem, costing life in more that one million people every year worldwide. Even if SB is considered as a consequence of social adversity and depression, these stress factors are often necessary but not sufficient to explain the occurrence of a suicidal act. A preliminary study suggests that an increased perception of psychic pain during a major depressive disorder increases the risk of suicide behaviour. The investigators aimed to investigate the relationship between social exclusion (a classic trigger of psychic pain) and SB and improve our knowledge about the physiopathology of this domain.
Read the detailed description
Suicide behaviour (SB) represents a major public health problem. In order to improve prevention strategies, a better understanding of the physiopathology of SB is needed. According to a "stress vulnerability" model, people who make a suicide attempt when they are subject to a stress factor (environmental stress, interpersonal difficulties, depression, tobacco, substance abuse...) are those who have a specific vulnerability. Vulnerability factors to SB may be considered in clinical terms (propensity to hopelessness, aggressive impulsivity traits), neurobiological terms (serotoninergic system disorder, especially in the ventral prefrontal cortex-vPFC) and cognitive terms (decision making, cognitive functions mediated by the vPFC and the serotoninergic system). Finally, genetic factors seem also involved in suicide vulnerability. The investigators have conducted a preliminary study which suggests that increased perception of psychic pain during a major depressive disorder increases suicidal ideation and suicidal act. Study about anatomic basis of psychic pain and its triggers represents a relevant theme to understand the suicidal process. Among the classical factors triggering psychic pain and suicidal act, events of social exclusion appears to be crucial. Finally, many data suggests the close relationship between physic and psychic pain.
- Conditions
- Suicide, Attempted, Mood Disorder
- Being tested
- Assessment of personality traits, Assessment of suicidal act, Assessment of depression, Cyber ball game, Iowa Gambling Task
- Keywords
- Psychic pain, Social exclusion, Mood disorders, Suicide, attempted, Magnetic Resonance Imaging, Functional, Genetic, Physic pain
- Medical subject headings
- Suicide, Attempted, Mood Disorders, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of personality traitsBehavioural
Also called impulsivity, anger, anxiety, emotional lability
suicide behaviour , psychic pain, social exclusion, decision making...
Assessment of suicidal actBehavioural
Also called SIS, RRRS
suicide behaviour , psychic pain, social exclusion, decision making...
Assessment of depressionBehavioural
Also called BDI, HAMD-21
suicide behaviour , psychic pain, social exclusion, decision making...
Cyber ball gameProcedure or surgery
Also called fIRM
functional neuroimaging
Iowa Gambling TaskProcedure or surgery
functional neuroimaging
MicrocomputerProcedure or surgery
Also called palm
functional neuroimaging
blood sampleProcedure or surgery
blood sample
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Behavioral: Assessment of personality traits; Behavioral: Assessment of suicidal act; Behavioral: Assessment of depression; Procedure: Cyber ball game; Procedure: Iowa Gambling Task; Procedure: Microcomputer; Procedure: blood sample |
| Depressive attempters | Experimental | Not described Receives: Behavioral: Assessment of personality traits; Behavioral: Assessment of suicidal act; Behavioral: Assessment of depression; Procedure: Cyber ball game; Procedure: Iowa Gambling Task; Procedure: Microcomputer; Procedure: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral regions associated with psychic pain during a major depressive disorder
Magnetic Resonance Imaging to visualize cerebral regions associated with psychic pain during a major depressive disorder
Measured: One day
Cerebral regions associated with perception of social exclusion
Magnetic Resonance Imaging to visualize the cerebral regions associated with perception of social exclusion
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completionDec 2014
Why it stopped: difficult to patient inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Philippe PC Courtet, Professor(MD-PhD), Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493323
- Sponsor's protocol ID
- UF 8555
- Status last verified
- Dec 2014
- First submitted
- 10 Nov 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro Anatomic Basis of Psychic Pain in Depression and Suicidal Behaviour
- ClinicalTrials.gov ID
- NCT01493323
- Acronym / sponsor ID
- UF 8555
- Conditions
- Suicide, Attempted, Mood Disorder
- Keywords
- Psychic pain, Social exclusion, Mood disorders, Suicide, attempted, Magnetic Resonance Imaging, Functional, Genetic, Physic pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult to patient inclusion
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Dec 2011 (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.
Suicidal behaviour (SB) represents a major public health problem, costing life in more that one million people every year worldwide. Even if SB is considered as a consequence of social adversity and depression, these stress factors are often necessary but not sufficient to explain the occurrence of a suicidal act. A preliminary study suggests that an increased perception of psychic pain during a major depressive disorder increases the risk of suicide behaviour. The investigators aimed to investigate the relationship between social exclusion (a classic trigger of psychic pain) and SB and improve our knowledge about the physiopathology of this domain.
Detailed description
Suicide behaviour (SB) represents a major public health problem. In order to improve prevention strategies, a better understanding of the physiopathology of SB is needed. According to a "stress vulnerability" model, people who make a suicide attempt when they are subject to a stress factor (environmental stress, interpersonal difficulties, depression, tobacco, substance abuse...) are those who have a specific vulnerability. Vulnerability factors to SB may be considered in clinical terms (propensity to hopelessness, aggressive impulsivity traits), neurobiological terms (serotoninergic system disorder, especially in the ventral prefrontal cortex-vPFC) and cognitive terms (decision making, cognitive functions mediated by the vPFC and the serotoninergic system). Finally, genetic factors seem also involved in suicide vulnerability. The investigators have conducted a preliminary study which suggests that increased perception of psychic pain during a major depressive disorder increases suicidal ideation and suicidal act. Study about anatomic basis of psychic pain and its triggers represents a relevant theme to understand the suicidal process. Among the classical factors triggering psychic pain and suicidal act, events of social exclusion appears to be crucial. Finally, many data suggests the close relationship between physic and psychic pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Assessment of personality traits, Behavioral: Assessment of suicidal act, Behavioral: Assessment of depression, Procedure: Cyber ball game, Procedure: Iowa Gambling Task, Procedure: Microcomputer, Procedure: blood sample |
| Depressive attempters | Experimental | Behavioral: Assessment of personality traits, Behavioral: Assessment of suicidal act, Behavioral: Assessment of depression, Procedure: Cyber ball game, Procedure: Iowa Gambling Task, Procedure: Microcomputer, Procedure: blood sample |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Assessment of personality traitsAlso: impulsivity, anger, anxiety, emotional labilitysuicide behaviour , psychic pain, social exclusion, decision making... | Behavioural | Control, Depressive attempters |
| Assessment of suicidal actAlso: SIS, RRRSsuicide behaviour , psychic pain, social exclusion, decision making... | Behavioural | Control, Depressive attempters |
| Assessment of depressionAlso: BDI, HAMD-21suicide behaviour , psychic pain, social exclusion, decision making... | Behavioural | Control, Depressive attempters |
| Cyber ball gameAlso: fIRMfunctional neuroimaging | Procedure or surgery | Control, Depressive attempters |
| Iowa Gambling Taskfunctional neuroimaging | Procedure or surgery | Control, Depressive attempters |
| MicrocomputerAlso: palmfunctional neuroimaging | Procedure or surgery | Control, Depressive attempters |
| blood sampleblood sample | Procedure or surgery | Control, Depressive attempters |
Primary outcome
Cerebral regions associated with psychic pain during a major depressive disorder
Time frame: One day
Magnetic Resonance Imaging to visualize cerebral regions associated with psychic pain during a major depressive disorder
Cerebral regions associated with perception of social exclusion
Time frame: One day
Magnetic Resonance Imaging to visualize the cerebral regions associated with perception of social exclusion
Results and safety
The study was stopped early (reason given: difficult to patient inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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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.
Philippe PC Courtet, Professor(MD-PhD) principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of personality traits, Assessment of suicidal act and Assessment of depression in people with Suicide, Attempted and Mood Disorder, 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?
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: stopped early, as of the sponsor's last update on 4 Dec 2014. 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?
The study was stopped early (reason given: difficult to patient inclusion). 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?
Cerebral regions associated with psychic pain during a major depressive disorder (time frame: One day). The study lists 2 primary outcomes in all. 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 4 Dec 2014.