DepressionCOMPASSNCT03898648
Behavioral Adaptation to Negative Social Cues in Depressed Patients According to Personal History of Suicide Attempt- COMPASS
A study testing Waiting room task in people with Depression and History of Suicide Attempt, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Social interactions are part of daily life. To decide to interact with someone or not is a routine for humans. To ensure the quality of interpersonal relationships, emotional cues must be taken into account to adapt optimally the investigator's behavior. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, History of Suicide Attempt
- What is being tested?
- Waiting room task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 9 Apr 2019to 10 Oct 2021
- 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
- Being between 18 and 65 years old
- Meeting the DSM-5 criteria for a current major depressive disorder
- For suicidal patients : having a lifetime history of suicide attempt
- For affective controls : having no personal history of suicide attempt
- Being able to understand the nature, purpose and methodology of the study
- Having signed the informed consent
- Being affiliated to a social security system
Who cannot join
- Current depressive episode with psychotic characteristics
- Mental retardation or sever medical co-morbidity
- Lifetime Diagnosis of schizophrenia or schizoaffective disorder
- Current manic or hypomanic episode
- Sensory or cognitive disability
- Pregnant or breastfeeding woman
Show all 9Show fewer
- Deprivation of liberty (by judicial or administrative decision)
- Protection by law (guardianship or curatorship)
- Inability to understand, speak and write French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behavioral Adaptation to Negative Social Cues in Depressed Patients According to Personal History of Suicide Attempt
Social interactions are part of daily life. To decide to interact with someone or not is a routine for humans. To ensure the quality of interpersonal relationships, emotional cues must be taken into account to adapt optimally the investigator's behavior.
Difficulties in interpersonal relationships often trigger suicidal behavior. Suicide attempters are characterized by an impaired decision - making associated with difficulties in familial relationships.
Read more
To date, little data on emotional recognition and social decision- making in clinical population is available.
The study aims to compare behavioral response to negative social cues in 82 depressed patients according to their history of suicide attempt using a computerized neuropsychological task.
Read the detailed description
To identify the nature of the mechanisms involved in social decisions, Mennella and coll. have developed a computerized task (waiting room task) in which the participant is asked to avoid or to approach individuals expressing negative emotional expressions, in this case: anger or fear. In practice, participants have to choose between two chairs to sit in a waiting room in which subjects expressing a neutral face or negative emotions are present. To make this choice they must press a specific keyboard button. In addition to that, in order to evaluate motivation, some of the trials are reversed, meaning that the choice made by the participant will result in the opposite result.
Using this task they have shown that: (1) anger is associated with more avoidance behavior than fear, (2) this behavior is goal- directed and, (3) the higher the level of impulsivity of the subjects, the less able they are to adapt their responses.
The proposed study will use this neuropsychological assessment, the waiting room task, to evaluate if depressed patients would avoid or approach individuals expressing negative facial emotions. The main objective is to compare behavioral adaptation to anger vs neutral cues among depressed patients with and without history of suicide attempt.
The study also aims to :
- compare behavioral response to fear vs. neutral and anger vs. fear in depressed patients according to suicidal history ;
- assess the modulation of behavioral adaptation by history of childhood maltreatment, level of impulsivity, anxiodepression and anhedonia;
- correlate behavioral adaptation to negative cues (anger and fear) with decision-making performances using the Iowa Gambling Task.
The hypothesis is that depressed patients with a history of suicide attempt will exhibit anger specific hyper-responsiveness resulting in an increased avoidance behavior compared to subjects without suicidal history. It is expected that depressed suicide attempters will not have a different emotional reactivity compared to patients without suicidal history for another negative emotion, namely fear.
To that purpose, 82 depressed patients will be recruited in the study. Half of them will have a history of suicide attempt (suicide attempters) while the other half will have none (affective controls). Their participation will consist of an unique visit.
- Conditions
- Depression, History of Suicide Attempt
- Being tested
- Waiting room task
- Keywords
- Depression, Suicide attempt, Neuropsychology, Decision- making, Social interaction, Implicit Emotional processing
- Medical subject headings
- Depression, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waiting room taskOther
The waiting room task consists in a computerized neuropsychological task in which the participant is asked to freely choose a chair to sit in a waiting room. In a row of four chairs, the two in the middle are occupied by two males or females. One of the two subjects sitting either has a neutral face, or express a negative emotion (fear or anger).
To make their decision, participants must press the "S" keyboard button to go left or the "L" keyboard button to go right in a time limit of 1500 milliseconds.
One third of the time, the cursor moves in the opposite direction to that requested by the participant. For example, if the subject presses "S", the cursor moves to the right instead of to the left.
Those reverse trials are used to evaluate their motivation to correct the movement of the cursor.
The participant will repeat the task 360 times for the assessment to be completed.
| Study group | Role | What they receive |
|---|---|---|
| Depressed patients with history of suicide attempt | Experimental | Depressed patients with a lifetime history of suicide attempt will be evaluated regarding their behavioral adaptation toward negative social cues. Receives: Other: Waiting room task |
| Depressed patients without any history of suicide attempt | Experimental | Depressed patients without history of suicide attempt will be evaluated regarding their behavioral adaptation toward negative social cues. Receives: Other: Waiting room task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation to avoid anger during the emotional task
Calculation of the proportion of avoidance vs. approach choices from people expressing anger
Measured: At inclusion
Secondary outcomes (4)
Change in the proportion of avoidant choices in reverse trials compared to normal trials
Computerized calculation of the proportion of avoidance choices in reverse trials and comparison to the proportion calculated in normal trials.
Measured: At inclusion
Reaction time before clicking
Computerized measurement of reaction time before clicking to make the avoidant or approach choice
Measured: At inclusion
Reaction time between first and second choices in reverse tests
Computerized measurement of reaction time between the first choice and the second choice during the reverse condition
Measured: At inclusion
Iowa Gambling Test score
Decision- making impairment assessment with the Iowa Gambling Task. In this task participants are asked to choose between four piles of cards allowing them to earn or lose money. - Among those piles, two are advantageous (little gain and little loss) while the other two are disadvantageous (bigger gain but bigger loss). The goal is to earn as much money as possible. Persistence to choose the disadvantageous piles is interpreted to reflect impulsivity.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start9 Apr 2019
- Primary completion10 Apr 2021
- Study completion10 Oct 2021
Why it stopped: the follow up of the last patient has been done
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U960 - Cognitive Neuroscience Laboratory - Paris, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898648
- Sponsor's protocol ID
- RECHMPL19_0024
- Acronym
- COMPASS
- Status last verified
- Dec 2021
- First submitted
- 29 Mar 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Adaptation to Negative Social Cues in Depressed Patients According to Personal History of Suicide Attempt
- ClinicalTrials.gov ID
- NCT03898648
- Acronym / sponsor ID
- COMPASS / RECHMPL19_0024
- Conditions
- Depression, History of Suicide Attempt
- Keywords
- Depression, Suicide attempt, Neuropsychology, Decision- making, Social interaction, Implicit Emotional processing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the follow up of the last patient has been done
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM U960 - Cognitive Neuroscience Laboratory - Paris, France
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 2 Apr 2019 (actual)
- 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.
Social interactions are part of daily life. To decide to interact with someone or not is a routine for humans. To ensure the quality of interpersonal relationships, emotional cues must be taken into account to adapt optimally the investigator's behavior.
Difficulties in interpersonal relationships often trigger suicidal behavior. Suicide attempters are characterized by an impaired decision - making associated with difficulties in familial relationships.
To date, little data on emotional recognition and social decision- making in clinical population is available.
The study aims to compare behavioral response to negative social cues in 82 depressed patients according to their history of suicide attempt using a computerized neuropsychological task.
Detailed description
To identify the nature of the mechanisms involved in social decisions, Mennella and coll. have developed a computerized task (waiting room task) in which the participant is asked to avoid or to approach individuals expressing negative emotional expressions, in this case: anger or fear. In practice, participants have to choose between two chairs to sit in a waiting room in which subjects expressing a neutral face or negative emotions are present. To make this choice they must press a specific keyboard button. In addition to that, in order to evaluate motivation, some of the trials are reversed, meaning that the choice made by the participant will result in the opposite result.
Using this task they have shown that: (1) anger is associated with more avoidance behavior than fear, (2) this behavior is goal- directed and, (3) the higher the level of impulsivity of the subjects, the less able they are to adapt their responses.
The proposed study will use this neuropsychological assessment, the waiting room task, to evaluate if depressed patients would avoid or approach individuals expressing negative facial emotions. The main objective is to compare behavioral adaptation to anger vs neutral cues among depressed patients with and without history of suicide attempt.
The study also aims to :
- compare behavioral response to fear vs. neutral and anger vs. fear in depressed patients according to suicidal history ;
- assess the modulation of behavioral adaptation by history of childhood maltreatment, level of impulsivity, anxiodepression and anhedonia;
- correlate behavioral adaptation to negative cues (anger and fear) with decision-making performances using the Iowa Gambling Task.
The hypothesis is that depressed patients with a history of suicide attempt will exhibit anger specific hyper-responsiveness resulting in an increased avoidance behavior compared to subjects without suicidal history. It is expected that depressed suicide attempters will not have a different emotional reactivity compared to patients without suicidal history for another negative emotion, namely fear.
To that purpose, 82 depressed patients will be recruited in the study. Half of them will have a history of suicide attempt (suicide attempters) while the other half will have none (affective controls). Their participation will consist of an unique visit.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed patients with history of suicide attempt | Experimental | Other: Waiting room taskDepressed patients with a lifetime history of suicide attempt will be evaluated regarding their behavioral adaptation toward negative social cues. |
| Depressed patients without any history of suicide attempt | Experimental | Other: Waiting room taskDepressed patients without history of suicide attempt will be evaluated regarding their behavioral adaptation toward negative social cues. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being between 18 and 65 years old
- Meeting the DSM-5 criteria for a current major depressive disorder
- For suicidal patients : having a lifetime history of suicide attempt
- For affective controls : having no personal history of suicide attempt
- Being able to understand the nature, purpose and methodology of the study
Key exclusion criteria (9 listed)
- Current depressive episode with psychotic characteristics
- Mental retardation or sever medical co-morbidity
- Lifetime Diagnosis of schizophrenia or schizoaffective disorder
- Current manic or hypomanic episode
- Sensory or cognitive disability
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 |
|---|---|---|
| Waiting room taskThe waiting room task consists in a computerized neuropsychological task in which the participant is asked to freely choose a chair to sit in a waiting room. In a row of four chairs, the two in the middle are occupied by two males or females. One of the two subjects sitting either has a neutral face, or express a negative emotion (fear or anger). To make their decision, participants must press the "S" keyboard button to go left or the "L" keyboard button to go right in a time limit of 1500 milliseconds. One third of the time, the cursor moves in the opposite direction to that requested by the participant. For example, if the subject presses "S", the cursor moves to the right instead of to the left. Those reverse trials are used to evaluate their motivation to correct the movement of the cursor. The participant will repeat the task 360 times for the assessment to be completed. | Other | Depressed patients with history of suicide attempt, Depressed patients without any history of suicide attempt |
Primary outcome
Motivation to avoid anger during the emotional task
Time frame: At inclusion
Calculation of the proportion of avoidance vs. approach choices from people expressing anger
4 secondary outcomes
Change in the proportion of avoidant choices in reverse trials compared to normal trials
Time frame: At inclusion
Reaction time before clicking
Time frame: At inclusion
Reaction time between first and second choices in reverse tests
Time frame: At inclusion
Iowa Gambling Test score
Time frame: At inclusion
Results and safety
The study was stopped early (reason given: the follow up of the last patient has been done). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
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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 Waiting room task in people with Depression and History of Suicide Attempt, 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 7 inclusion and 9 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 5 Jan 2022. 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: the follow up of the last patient has been done). 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?
Motivation to avoid anger during the emotional task (time frame: At inclusion). 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 5 Jan 2022.