Suicidal BehaviorNCT02960191
Functional Neuroimaging and Genetic Vulnerability to Suicidal Behavior
A study testing Magnetic resonance imaging (MRI) in people with Suicidal Behavior, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Suicidal Behavior
- What is being tested?
- Magnetic resonance imaging (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Mar 2012
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- right-handed
- arm suicidal : Personal history of unipolar depressive disorder or bipolar disorder and having realized in his life at least one suicide attempt
- arm emotional Witnesses : Personal history of unipolar depressive disorder or bipolar disorder and have never done in his life attempted suicide
- arm healthy Witnesses : any current or past personal history of psychiatric disorders of Axis I and have never done in his life attempted suicide
Who cannot join
- Cons-indications to the use of MRI
- Existence of a past history of head trauma with loss of consciousness or neurological brain disorder or secondary neurological suffering suicidal gesture.
Trial locations and contacts
1 site in 1 country.
About this study
The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.
- Conditions
- Suicidal Behavior
- Being tested
- Magnetic resonance imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Device
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Other | subject with no current or past personal history of psychiatric disorders and about never having carried out suicide attempt Receives: Device: Magnetic resonance imaging (MRI) |
| emotional witness | Other | subject having had a personal history of unipolar or bipolar depressive disorder and who have never done in his life attempted suicide Receives: Device: Magnetic resonance imaging (MRI) |
| patient suicide | Other | subject having had a personal history of unipolar or bipolar depressive disorder and having realized in his life at least one suicide attempt Receives: Device: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI variations
activation of specific brain areas during the procurement of a test decision
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startDec 2008
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: recruitment difficult
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal BehaviorStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 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
- NCT02960191
- Sponsor's protocol ID
- 7887
- Status last verified
- Nov 2016
- First submitted
- 30 Aug 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Neuroimaging and Genetic Vulnerability to Suicidal Behavior
- ClinicalTrials.gov ID
- NCT02960191
- Acronym / sponsor ID
- 7887
- Conditions
- Suicidal Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficult
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 9 Nov 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.
The main objective is to highlight, by functional imaging (MRI) dysfunctional brain regions associated with vulnerability to suicidal behavior.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Other | Device: Magnetic resonance imaging (MRI)subject with no current or past personal history of psychiatric disorders and about never having carried out suicide attempt |
| emotional witness | Other | Device: Magnetic resonance imaging (MRI)subject having had a personal history of unipolar or bipolar depressive disorder and who have never done in his life attempted suicide |
| patient suicide | Other | Device: Magnetic resonance imaging (MRI)subject having had a personal history of unipolar or bipolar depressive disorder and having realized in his life at least one suicide attempt |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- right-handed
- arm suicidal : Personal history of unipolar depressive disorder or bipolar disorder and having realized in his life at least one suicide attempt
- arm emotional Witnesses : Personal history of unipolar depressive disorder or bipolar disorder and have never done in his life attempted suicide
- arm healthy Witnesses : any current or past personal history of psychiatric disorders of Axis I and have never done in his life attempted suicide
Key exclusion criteria (2 listed)
- Cons-indications to the use of MRI
- Existence of a past history of head trauma with loss of consciousness or neurological brain disorder or secondary neurological suffering suicidal gesture.
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 |
|---|---|---|
| Magnetic resonance imaging (MRI) | Device | emotional witness, healthy volunteers, patient suicide |
Primary outcome
MRI variations
Time frame: at day 0
activation of specific brain areas during the procurement of a test decision
Results and safety
The study was stopped early (reason given: recruitment difficult). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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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 Magnetic resonance imaging (MRI) in people with Suicidal Behavior, 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 2 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: stopped early, as of the sponsor's last update on 9 Nov 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?
The study was stopped early (reason given: recruitment difficult). 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?
MRI variations (time frame: at day 0). 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 9 Nov 2016.