Clinical trial NCT05230043: The Choice of a Violent Suicidal Means: a MRI Study With Computational Modeling of Decision-making
Official title: The Choice of a Violent Suicidal Means: a MRI Study With Computational Modeling of Decision-making
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide, Attempted
Keywords: Neuroimaging
decision-making
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Four groups of participants will be recruited:

1. 20 individuals with personal history of mood disorder (bipolar disorder or depressive disorders) and at least one suicidal act committed with a violent means within the last 12 months.
2. 20 individuals with personal history of mood disorder (bipolar disorder or depressive disorders) and at least one suicidal act conducted within the last 12 months but no lifetime history of suicidal act with a violent means.
3. 20 individuals with personal history of mood disorder (bipolar disorder or depressive disorders) who never attempted suicide and have no family history of suicidal behavior up to the second biological degree.
4. 20 individuals with no personal history of major mental disorder or suicidal act and no family history of suicidal behavior up to the second biological degree.

Brief summary: The study authors hypothesize a combination of cognitive, brain structural, brain functional and brain connectivity impairments in Suicide Attempters compared to Patient Controls and Healthy Controls, with deficits more marked in suicide attempters using violent suicidal means including:

1. Impaired choices at the reversal learning task with responses influenced by immediate outcome. This deficit would be correlated with brain activity in ventromedial Prefrontal Cortex during resting state and with several peripheral markers of the 5HT-system.
2. Reduced loss aversion. These deficits would be related to altered dynamics of Blood-Oxygen Level Dependent signal in the dorsal and ventral striatum as well as in ventral Prefrontal Cortex/ orbitofrontal cortex during the loss aversion task. These deficits would also be correlated with several peripheral markers of the 5HT-system.
3. Increased pain tolerance facilitating the execution of a violent and possibly painful act. These deficits measured with the algometer would be correlated with several peripheral markers of the 5HT-system.
4. Reduced behavioral inhibition in aversive context at the orthogonalized GoNoGo task facilitating the choice of a violent means. These deficits would be associated with altered Blood-Oxygen Level Dependent signal in ventral Prefrontal Cortex/ orbitofrontal cortex and parietal cortex during the resting state and correlated with several peripheral markers of the 5HT-system.


Eligibility criteria: Inclusion Criteria:

* Right-handed (as assessed with the Edinburgh Handedness Scale).
* Agreement to participate and sign the informed consent form.
* Is insured or beneficiary of a health insurance plan.
* Speaks French.
* Suicide Attempters using Violent Means group:

  * a personal history of mood disorder (bipolar disorder or depressive disorders according to DSM-5 criteria measured with the MINI 7.0);
  * at least one suicidal act committed with a violent means within the last 5 years.
* Suicide Attempters using Non-Violent Means group:

  * a personal history of mood disorder (bipolar disorder or depressive disorders according to DSM-5 criteria measured with the MINI 7.0);
  * at least one suicidal act conducted within the last 5 years;
  * no lifetime history of suicidal act with a violent means.
* Patient Control group:

  * a personal history of mood disorder (bipolar disorder or depressive disorders according to DSM-5 criteria measured with the MINI 7.0);
  * never attempted suicide in their lifetime;
  * no family history of suicidal behavior up to the second biological degree.
* Healthy Control group:

  * no personal history of major mental disorder according to the MINI 7.0;
  * never attempted suicide in their lifetime;
  * no family history of suicidal behavior up to the second biological degree.

Exclusion Criteria:

* Current participation or in the exclusion period of another research protocol in a category 1 RIPH
* Currently under judicial protection, or under adult guardianship.
* Refusal to participate.
* Is pregnant or breast feeding.
* The suicide attempt may have impacted the brain functioning (e.g. following hanging, asphyxia by drowning, head trauma following jumping from height, bullet impact, etc). This criteria will be assessed clinically by the investigator.
* Mental retardation (known or observed during the interview).
* Current psychotic disorder (according to the MINI 7.0).
* Current hypomanic episode (according to the MINI 7.0).
* Current manic, mixed, rapid cycling episodes (according to the MINI 7.0).
* Alcohol or substance disorder within last 3 months (according to the MINI 7.0).
* Past major brain trauma (with loss of consciousness \> 1 minute).
* Contra-indication to MRI (metal in body (including due to suicidal act), claustrophobia, impossibility to lie still on the back during one hour).
* Electroconvulsive therapy within the last three months.

Primary outcomes:
measure: Brain activity between groups
timeFrame: Day 0
Secondary outcomes:
measure: Impaired reversal learning between groups
timeFrame: Day 0
measure: Loss aversion between groups
timeFrame: Day 1
measure: Pain tolerance between groups
timeFrame: Day 0
measure: Behavioral inhibition in aversive context between groups
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: Fabrice Jollant
role: STUDY_DIRECTOR
References: